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Telephone support for women during pregnancy and the first six weeks postpartum

  1. Tina Lavender1,*,
  2. Yana Richens2,
  3. Stephen J Milan3,
  4. Rebecca MD Smyth1,
  5. Therese Dowswell4

Editorial Group: Cochrane Pregnancy and Childbirth Group

Published Online: 18 JUL 2013

Assessed as up-to-date: 12 FEB 2013

DOI: 10.1002/14651858.CD009338.pub2


How to Cite

Lavender T, Richens Y, Milan SJ, Smyth RMD, Dowswell T. Telephone support for women during pregnancy and the first six weeks postpartum. Cochrane Database of Systematic Reviews 2013, Issue 7. Art. No.: CD009338. DOI: 10.1002/14651858.CD009338.pub2.

Author Information

  1. 1

    The University of Manchester, School of Nursing, Midwifery and Social Work, Manchester, UK

  2. 2

    University College London Hospital Foundation Trust, Elizabeth Garett Anderson and Obstetric Hospital, London, UK

  3. 3

    St George's University of London, Population Health Sciences and Education, London, UK

  4. 4

    The University of Liverpool, Cochrane Pregnancy and Childbirth Group, Department of Women's and Children's Health, Liverpool, UK

*Tina Lavender, School of Nursing, Midwifery and Social Work, The University of Manchester, Oxford Road, Manchester, M13 9PL, UK. tina.lavender@manchester.ac.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 18 JUL 2013

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Characteristics of included studies [ordered by study ID]
Bloom 1982

MethodsRCT. 3 groups of primiparous breastfeeding mothers; 51 in the experimental and 49 in the control group.  The study involved a 3rd group of formula-feeding mothers n = 57; this non-randomised group is not included in the results in the review.


ParticipantsSetting: hospital in Halifax, Nova Scotia, Canada. 100 women recruited 3 days after birth – all interviewed by same female research assistant (nurse who had breastfed own child).  

Inclusion criteria: primiparous breastfeeding mothers.

Exclusion criteria: multiparous mothers excluded from study to remove effects of previous breastfeeding experience.  Also excluded were mothers with baby below 2500 g at birth or where Apgar at 5 minutes was below 5, those who had operant deliveries or twins, those relinquishing their infants, single mothers and those who did not speak/understand English.


InterventionsAll breastfeeding women received pamphlet on breastfeeding technique and infant behaviour. 

Experimental group (51) received 3 telephone calls at 1-week intervals beginning 10 days postpartum (to offer support to breastfeeding mother). All calls were made by same nurse and were described as friendly 5-10 minute conversations asking about experiences with her baby and breastfeeding.  Advice on breastfeeding and infant behaviour in general was offered.  Problems described and changes of feeding practice were recorded. Mothers expressing special concern or requesting medical advice were reassured and referred to nurse (specialised in breastfeeding guidance) at the maternity hospital.  During the first call mothers were asked if they had found the information pamphlet helpful. Calls were discontinued when a mother stopped breastfeeding

Control group: (49 women). All breastfeeding mothers received pamphlet on breastfeeding technique and infant behaviour. 


OutcomesAt 6 weeks postpartum a second female interviewer called (unaware of which group allocated to or changes with feeding practice) for 10-minute interview to assess mothers adjustment to the first few weeks at home with baby and aspects of the infant's behaviour.

Reports: ‘the average duration of breastfeeding was extended one week for the experimental group (mean 28.6 days v 21 days P = 0.05)’.  (SD was not reported so we imputed a SD based on the P value given in the paper P = 0.05). 

On page 12 authors refer to Fig 1 but there are no figures in the paper.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskStudy described as randomised – no further detail provided. 

Allocation concealment (selection bias)Unclear riskStudy described as randomised – no further detail provided. 

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding of women and staff providing care not feasible.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskSecond nurse collecting outcome data was reported to be blinded to allocation but it is unclear how effective this would have been in practice as it may have become quickly apparent in conversation with a mother which group she had been allocated to.

Incomplete outcome data (attrition bias)
All outcomes
Low risk1 woman lost to follow-up.

Selective reporting (reporting bias)Unclear riskMost of the results were not comparisons of the randomised groups. It was not clear when women were followed up. It was reported that there were telephone interviews at 6 weeks but - mean duration of breastfeeding in the intervention and control groups was reported but no SD was reported. Also if follow-up was at 6 weeks postpartum; reporting the mean suggests that all women had discontinued breastfeeding by 6 weeks but elsewhere it was stated that 25% of the breastfeeding control group changed to formula feeding within 6 weeks, which suggests that most women were still breastfeeding.

Other biasUnclear riskResults were confusing. Samples from 2 different studies were compared, randomised and non-randomised women were compared. Results were not reported in full.

Boehm 1996

Methods2-arm RCT with individual randomisation (a 2nd non-randomised control group have not been included in the analysis).


ParticipantsSetting: 42 women at high risk of preterm birth attending 2 hospitals in the USA between 1989 to 1993; recruitment from 20 weeks’ gestation. 

Inclusion criteria: 18 years or more, previous preterm birth (< 37 weeks and not related to incompetent cervix, multiple gestation, pregnancy-induced hypertension or intrauterine growth retardation), 20 weeks' gestation or more and absence of maternal conditions that might lead to early delivery (e.g. diabetes or drug abuse), telephone access at home. 


InterventionsIntervention group (21 women) in addition to usual care, daily telephone calls from recruitment to delivery from the research nurse, women were asked about symptoms and opportunity for women to discuss any concerns.

Control group (21 women) usual care which included 24 hour phone access help line if they had any problems and prenatal visits at least fortnightly from 20 weeks to delivery.


OutcomesDiagnosis and treatment of preterm labour, number of prenatal visits, mode of delivery, mean length of hospital stay for mother and baby, gestational age at delivery and infant birthweight.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot described.

Allocation concealment (selection bias)Unclear riskNot described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot blinded.

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskIt appeared that all women randomised were followed up.

Selective reporting (reporting bias)Unclear riskAssessment from published study report.

Other biasUnclear riskGroups appeared comparable at baseline.

Bryce 1991

MethodsRCT (Zelen design), 2 arms with individual randomisation.


ParticipantsSetting: women attending 3 public hospitals of obstetrician or GP antenatal clinics in Perth, Western Australia. 1970 recruited and randomised.

Inclusion criteria: women were enrolled at their first antenatal visit if they had a history of preterm birth (< 2500 g), perinatal death, 3 or more first trimester miscarriages or more than 1 second trimester (12-19 weeks) miscarriages or antenatal haemorrhage in previous pregnancy.

Exclusion criteria: non-English speaking, more than 25 weeks’ gestation or if the fetus was dead.


InterventionsIntervention (983 women). In addition to usual care women received support during pregnancy by midwives. Women received additional home visits (at roughly 4-6 weeks intervals) and between visits midwives telephone women to provide general support and empathy rather than education or antenatal checks. It was not clear how many phone calls women received.

Control (987 women) women received usual antenatal care with no additional home visits or phone calls.


OutcomesPrimary outcome was incidence of preterm birth. Other outcomes included mode of delivery, and stillbirth and neonatal death.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskBlock randomisation (block size not stated) carried out by computer programmer.

Allocation concealment (selection bias)Low riskZelen method. Women were randomised before they consented. Outcomes for women who refused consent or could not be followed up were analysed along with women who received the intervention.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskStaff providing antenatal care were reported to be blind to group allocation. Women and those delivering the intervention would not be blind. The impact of lack of blinding on outcomes assessed was not clear.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskIt was not clear if outcome assessment was blinded.

Incomplete outcome data (attrition bias)
All outcomes
Low riskZelen randomisation method 93/983 in the intervention group either refused consent or not available to follow-up but were analysed by ITT.

There were very little missing outcome data for primary outcome.

Selective reporting (reporting bias)Unclear riskAssessment from published study report.

Other biasUnclear riskGroups appeared comparable at baseline.

Bullock 1995

MethodsRCT, 2 arms with individual randomisation.


ParticipantsSetting: 131 women recruited from outpatient department of a large public maternity hospital, general practice surgeries and self-referral to the study.  Recruitment between March 1993 and December 1993

Inclusion criteria:  women at less than 20 weeks' gestation, either single or in a relationship where partner was unemployed.

Exclusion criteria: being unable to access a telephone (no women were in this category).


InterventionsIntervention group: 65 women. Women in both the intervention and control groups received a package of educational materials. In addition women in the intervention group received a weekly telephone call from a trained volunteer. Calls started from initial assignment to intervention group until 12 weeks after baby was born.

19 women volunteers delivered the weekly calls (received training in healthy mothers/healthy babies, research methods, communication techniques, and general information about normal occurrences in the antenatal and postnatal period. Calls included questions about the pregnancy and health behaviours such as  alcohol and drug use, smoking and number of meals a day and in last week and when woman was going for next antenatal appointment, and whether she had felt stressed in the last week. Each volunteer contacted between 2-6 women.

Control group: given a package of publicly available educational material on healthy behaviours during pregnancy.


OutcomesAll interviewed (by the PI) 4 times during study: at baseline, 34 weeks' gestation, 6 weeks and 12 weeks' postnatal.  To assess stress level, social support from partner, social support from family and friends, self-esteem, anxiety, depression and a variety of health behaviours as well as demographic factors. In this report of the trial only baseline and 34 weeks data were included.  


NotesData are reported as baseline and late pregnancy means and P values but not SEMs. We have contacted the author to see if the corresponding SDs (or SEMs) are available.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated assignment’ in balanced blocks of 50.

Allocation concealment (selection bias)Unclear riskNot described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot mentioned.

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot described.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk131 women were randomised and 122 followed up; 3 women were lost from the control group and 6 from the intervention group. It was not clear whether there were further missing data.

Selective reporting (reporting bias)Unclear riskAssessment from published study report. Mean scores were provided with no SDs which meant that results were difficult to interpret.

Other biasLow riskAt baseline there were no differences in stress, social support, self-esteem, STAI and depression indices. 

Bullock 2009

MethodsRCT. Factorial design. Block randomisation into 4 groups. Randomisation at the individual level.


ParticipantsSetting: reported as: ‘Women (N = 695) attending 21 rural Women Infant and Children Nutritional Supplement (WIC) clinics in a Midwest state’  They were recruited ‘between January 2002 and October 2005'.

Inclusion criteria: reported as: Women ‘smoking at least 1 cigarette per day, spoke English, and were 18 years or older and less than 24 weeks gestation’.

Exclusion criteria: reported as ‘The most frequent reasons for ineligibility were age (below 18 years) and spontaneous abortion prior to the home visit’.


Interventions4 study groups  (695 randomised and included in ITT analysis).

For analysis in this review groups 1 and 2 (telephone support with or without booklet) were treated as the intervention group and 3 and 4 (no telephone support, with or without booklet) as the control group.

1. (170 women) telephone support plus booklet. Telephone support was by trained nursing staff. The intervention was scheduled weekly telephone calls at a time convenient to women. The purpose of the call was general support (information and emotional support) and smoking cessation messages were only offered when the nurses thought women would be receptive to them. Women also had access to 24-hour nurse support for any additional support needed. The intervention was designed to be responsive to individual support needs. Women also received 8 booklets (mailed weekly) with smoking cessation messages. (BEEP intervention = Behavioral Education Enhancement of Pregnancy)

Nurses delivering intervention received 80 hours training on the intervention and the study design.

2. (175 women) As 1 but telephone support intervention only (no booklets).

3. As group 1 but booklet only (179).

4. No intervention (171).


OutcomesThe main outcome was smoking cessation (salivary cotinine of 30 ng/mL or less). Samples were taken monthly during pregnancy and 6 weeks postpartum. Self-report data on smoking at 28-32 weeks and 6 weeks postpartum. (Information on stress and mental health was also collected at these time points but results are not reported.)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskReported as: 'Random assignments were prepared individually for each nurse, and assignments were computer generated in blocks of 40 for an evenly distributed workload'.

Allocation concealment (selection bias)Low riskReported as: ‘At the completion of the interview, the baseline assessment, the nurse opened an opaque, sealed envelope, prepared by the PI that contained the study group assignment’. It was not clear that all envelopes were accounted for.

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and clinical staff were not blinded and collection of self-reported outcomes was not blinded.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskCotinine analysis was blinded: ‘The laboratory was blind to study group assignment while running the cotinine analyses. The assistants who collected the monthly saliva sample may or may not have been blinded to the study group but the rule was to treat all the women the same way. The nurses who collected samples when they conducted the follow-up interviews in late pregnancy and 6-weeks postdelivery were aware of the study group assignment’.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskRelatively few women dropped out, however, there was a loss of cotinine samples (balanced across groups) for 165 women. An ITT analysis was carried out for the whole sample for the primary outcome, but other analysis was for 530 women. Complete data were available for 476 women (missing data were also relatively evenly spread across groups).

Selective reporting (reporting bias)Unclear riskIt was not clear whether the intervention aimed to address stress and mental health. Although data were collected on a range of measures of stress and mental health findings for these outcomes were not reported.

Other biasLow riskGroups appeared comparable at baseline. No other bias apparent.

Bunik 2010

MethodsRCT, 2-arm trial (with block randomisation). Randomisation at the individual level.


ParticipantsSetting: ‘primiparous women who delivered a term infant at an urban safety-net hospital in Denver Colorado’  Recruited February 2005 to May 2006.  The study hospital provided services to a predominantly Hispanic “medically underserved” population.

341 women randomised.

Inclusion criteria: ‘women 18 years or older who delivered a healthy, term, singleton infant, and who were willing to consider breastfeeding.

Exclusion criteria: ‘if their primary language was not English or Spanish, if they had medical complications that interfered with breastfeeding, and if they required a hospital stay longer than 72 hours for vaginal deliveries or longer than 96 hours for cesarean section, or if their infant had medical problems that required admission to the intensive care nursery or hospitalisation for more than 72 hours'.


InterventionsIntervention group: (161 women) the intervention was daily telephone support from the day following hospital discharge until 2 weeks postpartum. The intervention was by trained nurses following a specific protocol covering advantages and disadvantages of breastfeeding, cultural issues, technique, and discussion of problems with referral for any lactation or medical problems.

Control group: (180 women)  all women received usual hospital care which included pamphlets on breastfeeding, a breast pump, lanolin cream and a water bottle and usual discharge care with commercial discharge packs. Usual care also included scheduled healthcare visits at 3-5 days and at 2 weeks at the local community health centre


OutcomesDuration and exclusivity of breastfeeding, maternal satisfaction with feeding, rationale for discontinuing breastfeeding and healthcare utilisation.  Maternal confidence assessed at 3 months.  Assessed by maternal report over telephone at 1, 3 and 6 months postpartum.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated block randomisation.

Allocation concealment (selection bias)Unclear risk‘allocation assignment was not blinded and was done using sequentially numbered opaque sealed envelopes.’

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot mentioned.

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot mentioned.

Incomplete outcome data (attrition bias)
All outcomes
High risk341 women were randomised. At 1 month there approximately 8% loss to follow-up. By 6 months 27% loss. 73% were described as included in the analyses; women in the intervention group that did not receive the intervention as planned were not included.

Selective reporting (reporting bias)Unclear riskAssessment from published study reports.

Other biasLow riskGroups appear well balanced at baseline.

Dennis 2002

MethodsRCT, 2-arm trial with individual randomisation.


ParticipantsSetting: 2 hospitals (described as semi-urban) near Toronto, Canada. Recruitment Sept 1997 to June 1998.

258 women randomised. 

Inclusion criteria:  reported as ‘Eligible participants were all in-hospital, primiparous, breast-feeding women who were at least 16 years of age, able to speak English, had a singleton birth at 37 weeks’ gestation or later and resided in the surrounding region accessible by a local telephone call‘.  

“The majority of the 256 participants were married (91.4%), identified themselves as Canadian (73%), completed post-secondary education (74.7%), and had an annual household income greater than $40,000 Canadian (77.8%). The mean age was 29.0 years (SD = 4.68) ranging from 17”.

Exclusion criteria: reported as ‘Mothers were excluded if they had a factor that could significantly interfere with breast-feeding, such as serious maternal illness, infant congenital abnormality or an infant in the special care nursery who would not be discharged home with the mother. We also excluded mothers if they had enrolled prenatally with the participating volunteer breast-feeding organization'.


InterventionsReported as: ‘conventional care plus telephone-based support, initiated within 48 hours after hospital discharge, from a woman experienced with breast-feeding who attended a 2.5-hour orientation session’.

Intervention group: (132 women allocated to intervention) usual care plus telephone support from peer volunteers to promote breastfeeding. Peer supporters were recruited by a local voluntary organisation specifically for the trial and received training. Volunteers had breastfeeding experience, positive attitudes about breastfeeding and completed 2.5 hours training session and provided with handbook with information and details of referral contacts. Volunteers were paired with women and asked to contact them by telephone within 48 hours of hospital discharge. The number and timing of subsequent telephone contacts were not prescribed (volunteer logs suggested approximately 5 contacts lasting an average of 16 minutes). Most contacts were initiated by the volunteers. The purpose of the calls was to provide information, feedback and emotional support.

Control group: (126 women) usual care which included hospital and community support by nursing and medical staff, access by telephone to a breastfeeding support line, access to a hospital lactation consultant clinic.


OutcomesOutcome data collected at baseline, then at 4, 8, and 12 weeks postpartum. Primary outcome – self-reported breastfeeding in the 24 hours before the 12-week telephone interview.

Secondary outcomes, breastfeeding duration (any, exclusive) maternal satisfaction with feeding, problems with breastfeeding, health service utilisation, perceptions re peer support.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskReported as: ‘Randomization was achieved using consecutively numbered, sealed, opaque envelopes containing randomly generated numbers constructed by a biostatistician who was not involved in the recruitment process'.

Allocation concealment (selection bias)Low riskReported as: ‘Randomization was achieved using consecutively numbered, sealed, opaque envelopes containing randomly generated numbers constructed by a biostatistician who was not involved in the recruitment process'.

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and staff would not be blind to intervention. Outcome data were reported by women in telephone interviews.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome data collected by research assistants reported to be blind to allocation (it was not clear whether blinding was successful). Data entry also by blinded investigators.

Incomplete outcome data (attrition bias)
All outcomes
Low risk258 women were randomised and all but 2 (both in the control group) were followed up at all 3 data collection points.The authors stated that analysis was according to ITT with women analysed according to allocation whether or not they received the intended intervention. Secondary analysis looked at treatment effect according to the intervention received.

Selective reporting (reporting bias)Low riskAdditional data provided by the author.

Other biasUnclear riskThere was some baseline imbalance; there was a significant difference between 2 groups on ‘Decided to breast-feed before pregnancy’ (with more doing so in peer support than in control group) and fewer women in the peer support group than in the control group had a cesarean section (18.9% v. 27.4%); 'although this difference is not statistically significant, it is clinically important’.

Dennis 2009

MethodsMulti-site RCT, 2 arms with individual randomisation.


ParticipantsSetting: reported as: “Women were recruited from seven large health regions and their corresponding public health departments across Ontario, Canada, between November 2004 and September 2006.” 701 women randomised.

Inclusion criteria:  women were assessed at routine telephone call by public health nurse 24-48 hours after hospital discharge after birth. Participants were women approximately 2 weeks postpartum scoring more than 9 on the EPDS ‘Eligible participants were all new mothers about two weeks postpartum or less who were at least 18 years of age, able to speak English, had a live birth, and were discharged home from hospital'.

Exclusion criteria: described as: ‘We excluded women whose babies were not discharged home with the mother and women who were currently taking antidepressant or antipsychotic drugs'.


InterventionsIntervention group: usual care and peer support (n = 349),  Reported as ‘Proactive individualised telephone based peer (mother to mother) support, initiated within 48-72 hours of randomisation, provided by a volunteer recruited from the community who had previously experienced and recovered from self reported postnatal depression and attended a 4-hour training session.’The volunteers were asked to make a minimum of 4 contacts and to interact and refer to other agencies as necessary. Women received a mean of 8.8 (SD 6.0) contacts (but this included answer machine contacts). 7% of contacts were initiated by the participants.

Control group: usual care (n = 352) women could proactively seek services from public health nurses, doctors, and other community resources.


OutcomesReported as: ‘Main outcome measures Edinburgh postnatal depression scale, structured clinical interview-depression, state-trait anxiety inventory (STAI), UCLA loneliness scale, and use of health services’.  Also maternal satisfaction with intervention.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskReported as ‘Randomisation was centrally controlled with a web based randomisation service (www.randomize.net), with stratification based on self reported history of depression, a known risk factor for postnatal depression’.

Allocation concealment (selection bias)Unclear riskAlthough a centralised external randomisation service was used it was not clear what happened at the point of randomisation.

Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen and staff delivering the intervention were not blind to group allocation.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskReported as ‘Research nurses blinded to group allocation telephoned all participants at 12 and 24 weeks postpartum to assess trial outcomes. At 12 weeks, women in the intervention group answered questions regarding their experience with the peer volunteer via a mailed questionnaire. While trial participants and peer volunteers could not be blinded to group allocation, health professionals and service providers of standard community postpartum care were not informed of any mother’s participation in the trial or group allocation.’

‘To assess for blinding of the outcome assessor, at the end of the interview the data collection nurses indicated whether they thought the participant was in the control group or the intervention group or they did not know. At the 12 week interview, the data collection nurses had no opinion regarding which group 595 (97%) women were allocated to; a similar rate was found at the 24 week interview (n = 588, 98%).’

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskOf 349 women randomised to the intervention group, 297 (85.1%) were followed up at 12 weeks and 289 (82.8%) at 12 weeks; for controls 352 randomised, 316 (89.8%) were followed up at 12 weeks and 311 (88.3) at 24 weeks. Fewer women in the intervention group were followed up at 24 weeks. It is possible that women lost to follow-up were more likely to be depressed.

Selective reporting (reporting bias)Unclear riskAssessment from published study report.

Other biasLow riskAuthors reported that ‘There were no clinically important differences between the two groups'. Other bias not apparent.

Di Meglio 2010

MethodsRCT, 2 arms with individual randomisation.


ParticipantsSetting: recruited from 2 Rochester NY USA hospitals between Sept 1996 to June 1997.  Women were approached 12-36 hours after vaginal or 24-48 hours after caesarean delivery.

78 mothers randomly assigned (38 receiving telephone peer support and 40 not receiving this support).

Inclusion criteria: breastfeeding single infant.  Aged under 20 years.  No contraindications to breastfeeding and uncomplicated postpartum course.  For infant: gestation age above 36 weeks, weight above 2000 g, not in ICU or special care unit for more than 6 hours, no anomalies that would interfere with nursing (cleft lip or palate) and discharged home with mother.


InterventionsIntervention group: (40 women) peer telephone support 2, 4 and 7 days post discharge and then at 2, 3, 4 and 5 weeks post discharge.  Peers introduced themselves and asked about breastfeeding experience and gave mother telephone number so she could also call them. 5 adolescents who had recently breastfed were trained* to give support.  *Peer counselor training programme – 10 2 hour sessions developed and delivered by La Leche League leaders.  They were advised to refer the young women who were experiencing problems for breastfeeding information or to their physician.  Intervention based on breastfeeding promotion information disseminated by the Women Infants and Children (WIC) programme. An independent interviewer called all mothers weekly to determine feeding patterns – every week for 5-10 minute interviews for 4 weeks and then every two weeks for 4 weeks, and then once a month until breastfeeding stopped to review infant feeding.

At 1, 2, 3, 4, 6 and 8 weeks postpartum (for completing this they received a 25$ mall certificate). Peer counsellors and the mothers in intervention group could meet at monthly pizza parties.

Control group: (38 women) Women received standard care (no telephone support from peers) both intervention and control groups had access to other care including paediatric care and hospital lactation consultants.


OutcomesPrimary: breastfeeding duration (i.e. age when breastfeeding ceased).

Secondary: exclusive breastfeeding duration (i.e. age when supplement introduced – water, juice, vitamins or formula).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated random numbers.

Allocation concealment (selection bias)Low riskSealed numbered envelopes.  Only PI aware of group assignment and had no contact with participants.

Envelopes were sequentially opened as participants were recruited.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskReported as ‘Subjects blinded to research hypothesis and group assignment’ .  However, mothers were aware of role of peer support adolescents in the study – and were therefore probably aware of the purpose of the study. It was not clear whether blinding was successful. 

Peer supporters were blinded to research hypothesis and group assignment, but again it was not clear whether attempted blinding was successful.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskReported as ‘Interviewer blinded to research hypothesis and group assignment'.

It is unclear how effective this attempt at blinding may have been given that participant and individuals giving peer support were aware peer support was being given and the interviewer in weekly conversation with the participant may have become aware that some individuals had received support and some had not.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk11 (of the 78) dropped out immediately.  54 were contacted at 8 weeks (end point of participation incentive)  In 13 who could not be contacted 8 had already discontinued breastfeeding and 5 were lost to follow-up. A further 16 dropped out between 8 and 37 weeks. 46 were successfully followed to breastfeeding cessation (22 in intervention and 24 in control group).

Authors state that an ITT analysis was carried out but this was not clear.

Selective reporting (reporting bias)Unclear riskThe analysis is presented in diagrams (Kaplan-Meier Curves) and are not simple to interpret. Assessment from published study report.

Other biasHigh riskThere was very poor compliance with possibly only half of the intervention group receiving the intervention. There was no apparent baseline imbalance between groups.

Donaldson 1988

MethodsRCT. 2-arm trial with individual randomisation/


ParticipantsSetting: University of California Medical Centre, USA January to July 1987

39 low risk primiparous women randomised to 6 weekly ‘nurse-initiated postpartum telephone contacts following hospital discharge’ (n = 19) versus standard postpartum nursing care (n = 20).

Inclusion criteria: low-risk women experiencing a ‘normal’ childbirth.  Primiparous women aged between 18 and 38 years, able to speak and read English, healthy term infant, currently living with father of baby, access to telephone.

Exclusion criteria: infant with anomaly, maternal or infant illness requiring hospitalisation beyond normal 1 or 2 day post delivery, maternal history of psychiatric disorder/substance abuse, maternal report of current significant distress or  unable to receive telephone contacts.


InterventionsIntervention group (19 women) 6 weekly nurse-initiated postpartum telephone contacts following hospital discharge’.  For ‘educational and supportive postpartum follow-up’. Delivered by a single staff clinical nurse specialist.  Most calls lasted 15-30 minutes.

Control: (20 women) standard postpartum nursing care which included nurse education prior to discharge from hospital.


OutcomesMaternal postpartum adaptation (maternal reported mood disturbance, maternal sense on competence as a parent, maternal developmental expectations).  Data collected at 8 weeks postpartum using mailed self-report questionnaires: Profile of Mood States (POMS) Parental sense of competence scale (PSOC) and Developmental Expectations (DE).  Mailed to mother at 6 weeks to be completed in own home – instructed to complete within 5 days of infant at 8 weeks of age. 

Data also included: mothers feelings about being a mother, perceived greatest concerns, mothers rating of general health/infant health.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskMentions table of random numbers – although process described as ‘subjects alternately assigned to each group based on their sequence of induction’.

Allocation concealment (selection bias)Low riskSealed and numbered envelopes (those inducting participants were blind to group assignment) and allocation known only when envelopes opened.

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding not feasible.

Blinding of outcome assessment (detection bias)
All outcomes
High riskDescribed as unmasked.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk46 recruited and 7 lost to follow-up.

Selective reporting (reporting bias)Unclear riskNot apparent.

Other biasUnclear riskRecruitment insufficient so study did not have the power to detect differences between groups.

No differences between groups for demographic and baseline variables.

Ershoff 1999

Methods3-arm trial with individual randomisation.


ParticipantsSetting: ‘Between November 1996 and June 1997 in a prospective, randomised trial we recruited women initiating prenatal care at Kaiser Permanente Southern California (KPSC)’. 

Inclusion criteria: 390 women. Women who had a prepregnancy smoking rate of 7 or more cigarettes per week and had not quit by recruitment, aged 18 or more, who had begun prenatal care by 26 weeks’ gestation.

Exclusion criteria: reported as ‘women under the age of 18 (n = 59) and those beginning prenatal care beyond the 26th week of pregnancy (n = 69)'.


Interventions3 study arms. Intervention focusing on smoking cessation.

1.    131 (controls) Booklet giving advice on stopping smoking.

2.    133 (booklet plus computer). Booklet with access to an interactive telephone computer programme free of charge. (Only 25 women accessed the service).

3.    126 (booklet plus motivational interviewing). Women in this group (intervention) had counselling from trained nurse educators. Counsellors were asked to complete 4-6 calls of 10-15 minutes duration with each woman assigned to them. Weekly calls were recommended but this was at the discretion of the nurses.

For this review we have used data for groups 1 (control) and 3 (intervention) only.


OutcomesReported as ‘Biochemically confirmed abstinence measured by level of cotinine in urine samples obtained during a routine prenatal visit at approximately the 34th week of pregnancy.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot described.

Allocation concealment (selection bias)Unclear riskNot described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen and clinical staff delivering the intervention were not blind to group allocation although it was reported that other care providers were blind to study participation and group assignment.

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBiochemical analysis for primary outcome.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskOf 390 women randomised, cotinine analysis was carried out for 332 (85%). Follow-up interview data were available for 285 women.

Selective reporting (reporting bias)Unclear riskThe way results were reported in tables was confusing and several results were for subsamples.

Other biasUnclear riskNo baseline imbalance apparent. Ther were considerable discrepancies between cotinine-validated quit rates and self-report measures.

Ferrara 2011

MethodsPilot RCT, 2 arms with individual randomisation.


ParticipantsSetting: 197 women receiving care through Kaiser Permanente Medical Care Program in Northern California USA. The study was carried out between 2005-2008.

Inclusion criteria; 96 women diagnosed with GDM.

Exclusion criteria:  aged under 18 years, multiple gestation, diabetic retinopathy, high-risk pregnancy (drug or alcohol abuse, chronic illness, thyroid disease or pregnancy complications), non-English speaker.


InterventionsIntervention group (96 women) a complex lifestyle intervention including telephone support encouraging changes in diet and exercise and promoting breastfeeding.  During pregnancy women had individual counselling from a dietician and this was followed by 2 telephone counselling contacts to encourage women to comply with IOM guidelines on weight gain and to engage in moderate intensity exercise. Women also received written information on diet. Towards the end of pregnancy women were referred to a lactation consultant who then scheduled between 1-4 telephone calls during the first 6 weeks after delivery to encourage breastfeeding. During the postpartum period women had 8-16 sessions on diet and exercise, 2 face-to-face with dieticians the rest over the telephone which encouraged women to exercise and reduce fat intake so as to regain their pre-pregnancy weight or reduce weight if they were overweight. Women were given diaries to monitor their exercise.

Usual care: 101 women received printed educational materials on GDM.


OutcomesBreastfeeding at 6 weeks and 7 months postpartum, reported amount of calories from fat and change in physical activity, number of women exceeding IOM weight gain goals at 6 weeks and 7 and 12 months postpartum.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskA computer randomisation program.

Allocation concealment (selection bias)Unclear riskNot described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot mentioned.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskIt was stated that research assistants collecting outcome data were unaware of group assignment. It was not clear if attempted blinding was successful.

Incomplete outcome data (attrition bias)
All outcomes
High riskIn the intervention group 20% were lost to follow-up by 12 months postpartum compared with 10% in the control group. It was not clear why loss was greater in the intervention group.

Selective reporting (reporting bias)Unclear riskAssessed from published study report.

Other biasUnclear riskResults were not consistent over time so some results were difficult to interpret. Groups appeared balanced at baseline.

Hoddinott 2012

MethodsPilot RCT, 2 arms with individual randomisation.


ParticipantsSetting: 69 women admitted to a maternity hospital in Scotland between July and October 2010.

Inclusion criteria: women living in the 3 most disadvantaged postcode areas served by the hospital and giving the baby some breast milk at hospital discharge.

Exclusion criteria: women under 16 or with serious medical or psychiatric problems or insufficient English to communicate by telephone.


InterventionsIntervention group: (35 women) proactive phone calls from hospital discharge up to 14 days by a member of the feeding team. The median number of calls per women was 8 calls and the median length was 3 minutes. The calls were to provide support. Women could also initiate calls themselves.

Control group: (34 women) reactive phone calls made by women up to 14 days pp. Only 1 woman called for advice.


OutcomesBreastfeeding or exclusive breastfeeding at 6-8 weeks. Satisfaction with care. Cost of intervention and service utilisation.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomisation by Internet randomisation sequence service set up by an independent  statistician. Stratified by parity.

Allocation concealment (selection bias)Low riskBy independent statistician. Women were only aware of allocation if they received calls.

Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen would be aware of calls and staff providing care may have been informed by women if they received calls.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskFollow-up at 6 weeks by researcher who was reported to be blind of study allocation and had no other contact with the women.

Effect on outcomes of partial blinding unclear.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk69 women were randomised and 11 lost to follow-up. It was stated that an ITT analysis was carried out for women with complete data at follow-up.

Selective reporting (reporting bias)Unclear riskPilot study. Assessment from published study report.

Other biasUnclear riskWomen in the intervention group were on average 1 year older and more likely to be living in the most disadvantaged areas and hospital stays were slightly longer, otherwise groups were comparable.

Jareethum 2008

MethodsRCT 2 arms with individual randomisation.


ParticipantsSetting: 68 healthy pregnant women who attended the antenatal clinic and delivered at a Bangkok hospital May-October 2007.

Inclusion criteria: age over 18 years old, no medical diseases or obstetric complications, singleton pregnancy, dating confirmed by ultrasound, gestational age less than 28 weeks at recruitment. All participants had their own mobile phone and could receive and understand short message service (SMS) messages. 

Exclusion criteria: pregnant women who aborted before 28 weeks of gestation or changed to deliver at another hospital were excluded after randomisation.


InterventionsNot clear how many randomised to intervention and control groups. At follow-up 32 in the intervention group and 29 in the control group.

Intervention group: SMS via mobile phone for prenatal support.  Reported as: ‘two SMS messages per week from 28 weeks of gestation until giving birth’. Added to same standard care as control. Message contained information and warnings relating to abnormal symptoms which, if the pregnant woman had, would require that they consult the doctor. The SMS messages were appropriate to the women’s gestational age.

Control group: standard care.

'Both groups received the same antenatal and perinatal care’.


OutcomesSatisfaction with antenatal and perinatal care (VAS) also anxiety scores (not clear how measured), gestational age at delivery, preterm delivery, birthweight and mode of delivery. Information was collected on the postnatal ward (therefore assessment of antenatal anxiety would be retrospective).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskReported as ‘table of random numbers’.

Allocation concealment (selection bias)Unclear riskNot described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot mentioned. Women would be aware of intervention and most outcomes were self-reported.  

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot mentioned. Most outcomes self-reported.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk68 women randomised, 61 followed up. It was not clear that loss was balanced across groups.

Selective reporting (reporting bias)Unclear riskAssessment from published study report.

Other biasUnclear riskGroups were reported to be comparable at baseline.

Johnson 2000

MethodsRCT, 2 arms with individual randomisation.


ParticipantsSetting: 254 women in 5 hospitals in Canada (unclear). 

Inclusion criteria: reported as ‘Women who gave birth at one of 5 hospitals who: identified herself as a smoker before pregnancy; quit smoking once aware of pregnancy or in attempting to become pregnant; ceased smoking for at least 6 weeks before delivery; if smoking occurred in 6 week period immediately before delivery smoked on fewer than 6 occasions; gave birth to a healthy infant not requiring hospitalisation beyond discharge of the mother; planned to remain in hospital for at least 24 hours; able to read and comprehend English; could be contacted by telephone’.


InterventionsIntervention group: 125 women in treatment group included in analysis.

Postpartum counselling intervention to prevent smoking relapse. The intervention was provided one-to-one by specially recruited and trained nurses. Women received initial counselling in hospital along with pamphlets and no smoking signs for their homes. There were then 8 postnatal phone calls (weekly during the first month, then fortnightly) which lasted between 1 and 20 minutes. Only 25% of the intervention group received all 8 calls.

Control group: 126 women in the analysis.

Received usual care (did not include any information about effects of smoking or prevention of smoking relapse).


OutcomesSelf-report smoking status, Bedfont EC50 Smokerlyzers, Carbon monoxide (CO) readings of 10 or more parts per million (ppm).  Continuous abstinence: complete avoidance of smoking during the entire 6-month period. Smoking cessation self-efficacy was measured by the Smoking Abstinence Self Efficacy Scale. 


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskBlock randomisation (in groups of 50) randomisation via ‘computer software package’.

Allocation concealment (selection bias)Unclear riskUnclear  “identification numbers randomly assigned to two groups”.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot described.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskAt 6 months after delivery both groups were interviewed by research assistants in own home who had not delivered the intervention and who were reported to be blind to group assignment.   Carbon monoxide in expired air was also measured for some women.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskFollow-up interviews actually occurred between 24 and 50 weeks after baseline data collection. 11 interviews conducted away from woman’s home and 19 were over telephone (so breathalyzer not completed. 6 from control and 4 from treatment refused to participate. They (the 10) were coded as failing to maintain abstinence as daily smokers – self-efficacy scores were not imputed for these 10 women.

3 women excluded from analysis: reported as: ‘ 1 assigned to control group but inadvertently given intervention and 3 were assigned to treatment group but did not receive any telephone contacts’.

Selective reporting (reporting bias)Unclear riskAssessment from published study report.  

Other biasUnclear riskIt was reported that smoking related variables were similar in the 2 groups at baseline.

Little 2002

MethodsRCT, 2 arms, randomisation by individual.


ParticipantsSetting: study in the USA. Reported as ‘Those taking part in the study were high-risk pregnant women who obtained prenatal care from two large obstetric clinics and delivered at a level-3 tertiary center’. Also reported ‘The first referral to the study was made in mid-March 1999, and the first delivery was in late November 1999. The last delivery was in mid-March 2001’.  

175 women randomised.

Inclusion criteria:  described as ‘high-risk pregnant women who obtained prenatal care from two large obstetric clinics and delivered at a level-3 tertiary center’, women were ‘primarily of minority cultural and racial backgrounds’ and predominantly low-income.

Only those with singletons were retained in final analysis regarding infant gestational age, infant birthweights, and costs. However, it appears that both those with singletons and twins were retained in final analysis of satisfaction.


InterventionsIntervention group (91 women): ‘The nurse case managers contacted the patients in the case-managed group every 7 to 14 days to assess their pregnancy status and offer support and teaching related to pregnancy and their diagnoses.' The patients could contact the nurse case managers with non-emergent questions or concerns. Appropriate written educational materials were sent after the initial assessment contact and throughout the pregnancy. Contacts were made by the nurse case managers, as appropriate, to the patient’s health care providers (physicians and home care agencies) to obtain information regarding the pregnancy status and/or plan of treatment, and to initiate and/or follow-up on home care services provided to the woman. A final contact was made after delivery to obtain delivery information and to complete a postpartum mother/infant assessment.

‘The treatment group participants were educated in the signs and symptoms of preterm labor, importance of good hydration throughout the pregnancy, and self-monitoring of fetal movement. They were encouraged to maintain good prenatal care by keeping their regular clinic appointments and to report concerns or questions to their health care providers. They were also encouraged to partner in decision-making regarding their own care. In certain cases the nurse case manager was able to assure that the participant obtained more thorough nutrition education’.

Control group: 84 women. Standard care. The control group was contacted twice during the study, once to complete the initial pregnancy risk screening and a final contact to gather delivery information and to complete a postpartum mother/infant assessment. No teaching or written educational materials were provided, and no contacts were made to healthcare providers involved in the control patients’ care.


OutcomesGestational age at delivery, birthweight, costs, satisfaction and mode of delivery.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskIt was reported that the study administrator randomly assigned women.

Allocation concealment (selection bias)Low riskAdditional information from the author:

For our study, we employed a nurse who would attend the clinic to explain the study to Medicaid patients and she would enrol them if they were interested in participating. She was not a case manager with ROSEBUD and was not involved in assignment of the patients to the ROSEBUD case managers. Our administrative assistant (not a nurse) would assign these patients randomly to the nurses who would be their ROSEBUD case managers. The treatment group patients were assigned to 1 of 2 nurses and a third nurse followed the control group… there was no involvement with the nurse enrolling the patients and also assigning them. We kept these 2 areas completely separate and the information about the patients was not known to the case manager nurses prior to being randomly assigned."

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot described. Different nurses were involved in the care of intervention and control group women.

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot mentioned.

Incomplete outcome data (attrition bias)
All outcomes
High risk175 women were randomised. Women who were difficult to contact, expecting twins or not available to follow-up were not included in the analysis. For patient outcomes relating to satisfaction there were data for only 71 women.

Selective reporting (reporting bias)Unclear riskThis study is very complicated in terms of reporting (largely because of lack of balance between groups); all results were adjusted for a number of related variables.   

Other biasUnclear riskSome baseline imbalance.  ‘The case management group (N = 61) and control group (N = 50) did not differ significantly in demographic characteristics, but authors report:

‘The treatment group had significantly larger proportions of patients with anemia, obesity, symptoms of preterm labor, and undiagnosed vaginal bleeding in pregnancy. The control group had significantly more patients who were substance abusers and more patients in the control group had poor prenatal care, but not significantly so. The treatment group contained more who were experiencing stress in their environments. Treatment group participants were more likely to have abnormal ultrasound results and to report decreased fetal movement. The groups did not differ significantly on such medical risk factors as mental illness, cardiac disease, chronic hypertension, gestational diabetes, or insulin dependent diabetes mellitus’.

With respect to birthweight analysis they note ‘A multiple analysis of variance with covariates was performed, controlling for maternal obesity and NICU admission, as well as study group, gestational age at referral, and number of preterm births.

Similarly, with respect to gestational age at delivery as they note ‘A multivariate analysis of variance and covariance also was performed on gestational age at delivery, controlling for study group (treatment or control), maternal age, gestational age at referral, number of preterm births, and admission to the NICU.' 

Lund 2012

MethodsCluster-randomised trial (24 primary healthcare clinics randomised) in Zanzibar.


Participants(24 healthcare facilities randomised in 2009-10) 2550 women attending for antenatal care at participating primary healthcare facilities. Women were recruited at their first antenatal appointment and were followed until 6 weeks postpartum. All pregnant women were eligible for inclusion.


InterventionsMobile phone intervention to encourage women to seek skilled attendants for the birth. All women received routine care which included at least four antenatal visits, offer of skilled attendant for the birth and at least one postnatal visit within 48 hours of the birth for women not delivering in healthcare facilities.

Mobile phone intervention (12 centres, 1351 women recruited). Women in the intervention group with phones received automated short mobile phone health education messages and mobile phone vouchers to allow women to call healthcare staff. All women received free mobile phone vouchers irrespective of whether or not they owned a phone (38% had their own phone). Messages encouraged women to attend antenatal care appointments, and to seek skilled attendance for the birth. Messages were tailored to gestational age. Midwives, ambulance drivers and healthcare staff were provided with phones.

Control group: (12 centres, 1286 women) usual care.


OutcomesThe number of women with skilled attendants at the birth. maternal death.


NotesWe contacted the author of this trial in January 2012 for more information to allow us to adjust data to take account of cluster- design effect. We have included adjusted results for this trial in an additional table.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskSimple random allocation.

Allocation concealment (selection bias)Unclear riskNot described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen and staff were not blind to the intervention.

Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding.

Incomplete outcome data (attrition bias)
All outcomes
Low riskData were available for women at all centres (24) randomised. Of 2637 women recruited 82 were not included in the analysis (no end of study data).

Selective reporting (reporting bias)Unclear riskAssessment from published study report. More data are available from this trial (future publications).

Other biasLow riskAnalysis accounted for cluster- design effect. No evidence of baseline imbalance between groups.

McBride 1999

MethodsRCT, 3 arms with individual randomisation.


ParticipantsSetting: 1007 women randomised. Women were stratified by site (2 sites) and baseline smoking status (2 levels: current smoker vs recent quitter). ‘The clinical sites for the trial were Group Health Cooperative of Puget Sound (Seattle) and Park-Nicollet of Minnesota. Group Health Cooperative is a health maintenance organisation that serves over 450 000 enrollees in western Washington State. Park- Nicollet is a multispecialty group practice with a patient base that is 60% health maintenance organisation and 40% traditional fee-for-service’.

Inclusion criteria: reported as ‘Women were eligible for the intervention trial if they completed the baseline survey, were fewer than 20 weeks pregnant, and reported being a current smoker or a recent quitter (had been a smoker in the 30 days before pregnancy but had quit by the time of the baseline survey)’.

Exclusion criteria: ‘women (Seattle n = 60; Minnesota n = 28) subsequently miscarried between baseline and the 28-week follow-up.’  And ‘22 women in Seattle were mailed the wrong intervention materials; they were also excluded'.


Interventions3-arm trial.

  1. Mailed self-help booklet on stopping smoking and tips to prevent relapse (control).
  2. Mailed booklet and a telephone support intervention during pregnancy. A personal letter and 3 antenatal telephone calls from a smoking counsellor based on motivational interviewing techniques. (mean call duration 8.5 minutes (SD 6.3 minutes). The aim of the calls was to encourage women to stop smoking or to support women who had stopped to prevent relapse.
  3. Mailed booklet and pregnancy telephone support plus 3 further calls in the postpartum period up to 4 months postpartum. Average call duration 7.7 minutes (SD 6.5 minutes) and postpartum newsletters at 2, 6 and 12 weeks postpartum.


(In this review data for groups 2 and 3 (telephone support) have been combined.)


OutcomesThe proportion of women who reported not having smoked in the previous 7 days at the 28-week follow-up.   

3 postpartum outcomes were assessed: postpartum relapse, the proportion of women who were abstinent at 28 weeks but had returned to smoking; postpartum cessation, the proportion who had been smoking at the 28-week follow-up but had not smoked any cigarettes in the 7 days preceding the postpartum follow-up; and postpartum 7-day prevalent abstinence, the proportion of all women randomised who had not smoked any cigarettes in the 7 days preceding the postpartum follow-up.

For women who reported stopping smoking there was saliva cotinine analysis although results were not reported (64%-78% of women who reported stopping smoking returned saliva samples – there was no ITT reported).


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskStratified randomisation, but it was not clear how this was carried out.

Allocation concealment (selection bias)Unclear riskStratified randomisation, but it was not clear how this was carried out.

Blinding of participants and personnel (performance bias)
All outcomes
High riskThe staff recruiting women and carrying out telephone follow-up were not involved in delivering the intervention or other care. Women and smoking counsellors would be aware of the intervention and the main outcome was a self-report measure.

Blinding of outcome assessment (detection bias)
All outcomes
High riskThe staff recruiting women and carrying out telephone follow-up were not involved in delivering the intervention or other care. Women and smoking counsellors would be aware of the intervention and the main outcome was a self-report measure.

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskThere were some post-randomisation exclusions. Of 1007 randomised, 88 miscarried and were excluded, and 22 women were mailed the wrong information and were excluded. 897 women were followed up. Response rates were good with 80% of women responding at all 4 data collection points.

Selective reporting (reporting bias)Unclear riskResults for cotinine analysis were not reported. Results were difficult to interpret as many were for subgroups (e.g. for women who had reported stopping at a given time point) and denominators were not clear).

Other biasUnclear riskGroups were similar at baseline although there were some differences in sample characteristics at the two sites and the analysis was adjusted to take account of these differences.

Milgrom 2011

Methods2-arm trial with individual randomisation.


ParticipantsSetting: 143 women were recruited from 2 hospitals in Melbourne, Australia when 20–32 weeks pregnant’.

Inclusion criteria: women were assessed for depression and women with high scores and a proportion of those with low scores were recruited (13 or more on EPDS or the Risk Assessment Checklist). 143 women recruited; 43 with high scores and 100 with low.

Exclusion criteria: reported as ‘1) inability to understand written English, 2) presence of psychotic symptoms, 3) extreme levels of distress requiring crisis management, or 4) stage of pregnancy >32 weeks gestation’.


InterventionsIntervention group (43) women received the Towards Parenthood intervention in addition to community networking. The intervention consisted of a self-help workbook which women read each week (8 sessions) and then discussed the content with a psychologist or trainee psychologist in a weekly telephone support session. The postnatal unit was completed 6 weeks following the birth. Telephone calls lasted approximately half an hour and allowed for tailored discussion and problem-solving around the unit content. Telephone calls were made by the therapist at a regular prearranged time each week. Psychologists followed structured session prompts and kept detailed notes.

8 telephone sessions were scheduled (covering 9 workbook units).  However there was considerable variability in terms of number of sessions that the mothers received;  ‘only 56/100 women in the intervention attended one or more sessions, and of these only 46 attended five or more sessions’.

Control group (100 women): routine care. Community networking was implemented as in the intervention condition. Women in routine care were sent the Towards Parenthood workbook post-study.


OutcomesIt was hypothesised that the intervention would be beneficial in terms of:

1) less depression, (Beck depression index II);

2) less anxiety, (Depression and anxiety Short scale (DASS));

3) less parenting dysfunction;

4) less general stress.

Outcomes were measured at 12 weeks postpartum.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk‘Women were allocated to either intervention or routine care via a coded, double-blinded, variable-length permuted block randomised treatment allocation schedule produced by an independent person prior to commencement. The schedule was stratified for screening score (high or low), to ensure a balanced representation across treatments, and was administered by a hospital administrator blind to coding’.

Allocation concealment (selection bias)Low riskSee above.

Blinding of participants and personnel (performance bias)
All outcomes
High riskThis was described as a double-blind study but women and psychologists would be aware of the intervention and most of the measures were self-report so it is difficult to assess the impact of lack of blinding on outcomes.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskThis was described as a double-blind study but women and psychologists would be aware of the intervention and most of the measures were self-report so it is difficult to assess the impact of lack of blinding on outcomes.

Incomplete outcome data (attrition bias)
All outcomes
High riskThere was considerable loss to follow-up. Of 143 randomised, observed data were available for only 89 (62%). An ITT analysis was carried out where scores were imputed for missing data using “maximum likelihood methods”.

Selective reporting (reporting bias)Unclear riskAssessment from published study report.

Other biasUnclear riskGiven the low compliance it was difficult to draw conclusions about effectiveness.

There was some baseline imbalance with more women in the intervention group with post-high school education but level of education was reported not to be associated with outcomes.

Mongeon 1995

MethodsRCT, 2 arms with individual randomisation.


ParticipantsSetting: 200 women attending prenatal care at primary care clinics in Quebec, Canada. 

Inclusion criteria: women planning to breastfeed for the first time (first time mothers or women who had not previously breastfed).


InterventionsIntervention group (100 women) usual care plus visits and phone calls by peer volunteers. Volunteers were woman who had previously breastfed and each volunteer contacted 1 to 3 women. Volunteers were trained and supervised and visited women at home once during the first month postpartum, then weekly phone calls for 6 weeks then fortnightly phone calls until the baby was 5 months old or until breastfeeding discontinuation.

Control group (100 women) usual care involved a home visit from a primary care nurse and then other visits and phone calls as required.


OutcomesBaseline data collected at 32 weeks' gestation and follow-up was at 6 months postpartum. Breastfeeding at 1, 2, 3, 4, 5 and 6 months after the birth, breastfeeding problems and women’s views about breastfeeding.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot described, (translated as “shared randomly in two groups by drawing numbered papers").

Allocation concealment (selection bias)Unclear riskNot described, (translated as “shared randomly in two groups by drawing numbered papers").

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot mentioned.

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot mentioned.

Incomplete outcome data (attrition bias)
All outcomes
High riskMost women were available for follow-up (6/200 lost to follow-up). More than 30% missing for some outcomes.  

Selective reporting (reporting bias)Unclear riskNot clear (assessment from translation notes).

Other biasUnclear riskNot clear (assessment from translation notes).

Moore 1998

Methods RCT 2-arm trial with individual randomisation. Analysis was stratified by race and age.


ParticipantsSetting: 1554 women randomised attending community clinics in North Carolina USA.

Inclusion criteria: Black women (all ages) white and other women at high risk of preterm birth and white and other women aged 18 or younger. English speaking, access to telephone with gestational age 22-32 weeks at entry.


InterventionsIntervention group: ‘Women in the intervention group received telephone calls from a registered nurse, one or two times weekly from 24 weeks’ through 37 weeks’ gestation'.'Nurse telephone calls were made on the schedule to which nurse and subject agreed, from the time of the home visit (22–32 weeks’ gestation) until the 37th week. The timing of the calls was designed to suit the woman’s convenience. The goal was three telephone contacts per week. Women without telephones could contact their primary nurse via the nurse’s pager when they were near a telephone. The nurse returned the call immediately. Although no formal script was followed, each telephone call addressed three major areas: assessment of health status (perception of uterine contractions and other pregnancy changes, color of urine as an assessment of hydration, number of meals eaten, number of cigarettes smoked, alcohol and drug use, and ingestion of a prenatal vitamin capsule on the previous day); recommendations based on assessment; and discussion of any additional issues important to the mother. The duration of each call was recorded. Three experienced nurses, hired specifically for the telephone intervention study, conducted the intake interviews and all of the telephone intervention'.

‘Women in the intervention group received additional instruction about the signs of preterm labor, and a schedule was established for the time and frequency of telephone calls they would receive from the nurse, as well as instructions about contacting the nurse by telephoning her pager number’.

Women were given a $25 dollar gift voucher if they returned their assessment and remained in contact with the nurse.

Control group: standard care. Women were given a booklet about preventing preterm birth which was available in the clinic and routine care. They were given a $10 gift voucher for completing assessments.


OutcomesLBW or preterm births. Cost data reported for a subsample.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer randomisation table.

Allocation concealment (selection bias)Low riskReported as; ‘Random assignment was directed by the biostatistician. The words “phone” for the intervention group and “book” for the control group were placed in opaque envelopes that were numbered and sealed by the biostatistician’.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskWomen were not blinded; it was reported that clinical staff were blind to intervention but it was not clear if this was successful. ‘Clinic personnel, including attending physicians, residents, nurses, and others were blinded to group assignment. If a referral to clinic, the labor suite, or another agency was needed, the nurse instructed the patient to make the call and then ascertained that the call was made’.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskData collection was done by an additional nurse hired specifically for this task. She did not participate in the intervention, was not present at any meetings during which patients were discussed, and was blinded to group assignment.’  It is not clear how effective the blinding would actually be in practice.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk121 women randomised; 7.8% changed healthcare providers, moved from the community, or had multiple gestation pregnancies.

It was stated that analysis was on an ITT basis.

Selective reporting (reporting bias)Unclear riskAssessment from published study report.

Other biasUnclear riskThere were no clear differences between groups at baseline; analysis was stratified by age and race.

Naughton 2012

MethodsRCT, 2 arms with individual randomisation.


ParticipantsSetting:  7 National Health Service Trusts in England between 2008-9. 207 women randomised.

Inclusion criteria: women recruited at booking visit by midwives. Gestational age less than 21 weeks, 16 years of age or more, smoked 7 or more cigarettes per week, had use of mobile telephone and could understand written English.


InterventionsIntervention group:  (MiQuit) women were mailed an individually tailored four page colour self-help leaflet by post, 3 days later automated phone text messages were sent. Women could be sent 0-2 texts each day randomly . The system sent out approximately 80 texts over the 11-week intervention period to each woman. Women could request instant response supportive texts at any time and could stop texts (102 women).

Comparison intervention: women were mailed a non-individually tailored self-help leaflet but received no phone intervention (105 women).


OutcomesMain outcomes were acceptability and self-efficacy scores. Women were also assessed at 3, 7 and 12 weeks and reported smoking behaviour (7 day point prevalence). Women who reported quitting at 12 weeks were asked to mail saliva sample for cotinine validation.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskStratified (by  baseline smoking rate)  block randomisation (block size 2) “Generation of the randomization tables and allocation of participants were implemented in a computer program and managed by [investigator] who had no contact with participants".                                         

Allocation concealment (selection bias)Low risk“Generation of the randomization tables and allocation of participants were implemented in a computer program and managed by {investigator} who had no contact with participants.” Allocation sequence was concealed from staff providing care and staff carrying out data collection.

Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen would not be blind to intervention. It was reported that clinical staff and staff collecting outcome data were blind  but women may have revealed allocation (24% in the intervention group thought the texts were annoying and 26% thought they got too many texts and may have revealed this before the final assessment).   

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskCotinine validation of reported quit rates would reduce detection bias for this outcome.    

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk207 women were randomised and 174 completed assessment at 12 weeks (84%). There were missing data for some outcomes and less than half of the women who reported quitting smoking had this confirmed by cotinine validation).

Selective reporting (reporting bias)Low risk(Supplementary information available.) No obvious outcome reporting bias.

Other biasUnclear riskGroups appeared similar at baseline apart form more participants in the control group had smoked in a previous pregnancy. Authors reported carrying out sensitivity analysis adjusted for this.

Parker 2007

MethodsRCT. 3-arm trial with individual randomisation.


ParticipantsSetting:1065 women attending for antenatal care at 22 urban clinics in Rhode island, Connecticut and Massachusetts, USA. 80% insured by Medicaid.

Inclusion criteria: women who were identified as smokers (smoked at least 1 puff of a cigarette in the previous 30 days), no more than 26 weeks’ gestation, have access to a phone and able to speak English or Spanish.


Interventions3 groups.

  1. (Control, 378 women) self-help materials to encourage smoking cessation including written materials and a video.
  2. (Control, 329 women). Self-help materials as group 1 plus entry into a lottery if women quit smoking.
  3. (Intervention, 358 women). Self-help materials, prize draw and up to 3 motivational interviewing telephone calls. The calls were made by trained counsellors and the objectives of the calls were to discuss women’s smoking behaviour, enhance perception of risks of smoking during pregnancy and to provide support.


OutcomesOutcomes included reported and cotinine-validated quit rates at 32 weeks and at 6 weeks and 6 months postpartum. Information on process variables and cost of the programme were also collected. The published paper does not report results by randomisation group and we were not able to include them in the analysis.


NotesWe contacted the author for more information on results and are awaiting a response.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskDescribed as “randomly assigned”.

Allocation concealment (selection bias)Unclear riskDescribed as “randomly assigned”.

Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen and staff would be aware of the intervention.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskReported smoking cessation was cotinine validated (but results by randomisation group not reported in this paper).

Incomplete outcome data (attrition bias)
All outcomes
High riskBy 6 months 688 (65%) of the 1065 randomised were available to follow-up.

Selective reporting (reporting bias)Unclear riskResults by randomisation group not reported in this paper.We contacted the author for more information on results and are awaiting a response.

Other biasUnclear riskResults focused on feasibility and process outcomes.

Pugh 2002

MethodsRCT 2 arms with individual randomisation.


ParticipantsSetting:  the trial was conducted between April 1999 and February 2000 in a large hospital in the USA.

Inclusion criteria 41 women on low incomes (receiving financial medical assistance support). Women were recruited in hospital after the birth of their baby.


InterventionsWomen in both groups received breastfeeding support from hospital nurses and all women had access to telephone advice. Women whose babies were born on weekdays were visited by a lactation consultant.

Intervention group (21 women) women received extra visits from the community health nurse or one of the peer counsellor team daily while they were in hospital then at home during weeks 1,2 and 4. In addition peer counsellors provided telephone support twice weekly until the babies were 8 weeks old and then weekly until the baby was 6 months old (even if the mother had stopped breastfeeding).

Control group (20 women) Usual care.


OutcomesDuration of breastfeeding, duration of exclusive breastfeeding, costs of care, health service utilisation.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot described.

Allocation concealment (selection bias)Unclear risk"assigned randomly by a sealed envelope technique.”

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot mentioned.

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot mentioned.

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo women appeared to be lost to follow-up.

Selective reporting (reporting bias)Unclear riskNot clear, assessment from published study report.

Other biasUnclear riskNot apparent.

Rasmussen 2011

Methods2 separate randomised trials are described in the same paper. Here we have included details of 1 of these trials examining postnatal telephone support. 2-arm RCT with individual randomisation.


ParticipantsSetting: hospital in a rural area of New York, USA with established health promotion and support for breastfeeding. May 2006-Feb 2007.

Inclusion criteria:  (50 women randomised) reported as ‘infant delivered at term and within the period of study data collection, ever put to the breast, not injured during delivery, and not placed in foster care or cared for elsewhere; mother still available for telephone contact... and those with a prepregnancy BMI > 29 kg/m2 were approached during one of their prenatal visits by a research assistant for the study. Women were enrolled in the studies if they intended to breastfeed, had no history of breast surgery, resided near Bassett Healthcare (Cooperstown), were least 19 years old, and were carrying a singleton fetus 35 weeks of gestational age at the time of enrolment'.


InterventionsParticipants in both groups received a telephone call during pregnancy from a lactation consultant, in the intervention group (targeted-care group) the pregnancy call was more detailed and women were asked about knowledge and expectations about breastfeeding and were given practical information. After the birth nurses encouraged women to get up and move around and encouraged visitors to give the woman privacy for breastfeeding. At 24 and 72 hours after hospital discharge women received additional calls from the lactation consultant and gave standardised advice and responded to questions and addressed any other issues that came up. If necessary the lactation consultant could arrange to visit the woman. 

Intervention group: 25 women randomised, 5 excluded post randomisation, 20 followed up (In the event only approximately half of the women received the scheduled telephone calls 11).

Control group: 25 women randomised, 5 excluded post randomisation, 20 followed up. (Only 11 women in the control group received the pregnancy phone call.)


OutcomesReported initiation of breastfeeding (still breastfeeding at 4 days after the birth), breastfeeding (any, 30 and 90 days postpartum) and exclusive breastfeeding (7 and 30 days). Duration of exclusive or any breastfeeding after hospital discharge.  Outcome data collected in telephone interviews with women.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot described.

Allocation concealment (selection bias)Unclear riskNot described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen and care providers were not blinded and would be aware of receiving the intervention.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskIt was stated that the research assistants recruiting women and carrying out interviews were not aware of participants assigned groups. Women may have disclosed this information.

Incomplete outcome data (attrition bias)
All outcomes
High risk50 women were randomised and 10 excluded post-randomisation (20%). It was stated that an ITT analysis was carried out but this was not for all women only those 40 that remained eligible and were followed up. Women were analysed by intervention group whether or not they received the intervention and large numbers of women (almost half) did not receive the scheduled phone calls (11 women in intervention and 11 in control received study phone calls).

Selective reporting (reporting bias)Unclear riskAssessment from published study report.

Other biasUnclear riskThere was some baseline imbalance; 'There were no statistically significant differences between treatment groups in the initial characteristics of mother–infant dyads.... However, women in the targeted-care group in BIBS 1 tended ( P < 0.07) to have a higher prepregnancy BMI as well as a higher ( P < 0.051) BMI at delivery than those in the usual-care group'.

Rigotti 2006

MethodsRCT, 2-arm trial with individual randomisation.


ParticipantsSetting: 442 pregnant smokers referred by Massachusetts prenatal providers. Pregnant smokers were identified from 2 sources: 1) Tufts Health Plan, a non-profit Massachusetts-based network-model managed care organisation, and 2) a group of community-based prenatal care practices. Recruitment 2001-2004.

Inclusion criteria:  ‘Pregnant women identified as current cigarette smokers at a prenatal care visit were recruited if they had smoked at least 1 cigarette in the past 7 days, were 18 years of age or older, at 26 weeks or less of gestation, willing to consider altering their smoking during the pregnancy, reachable by telephone, English- speaking, and expected to live in New England for the next year.

Exclusion criteria:  ‘The major reasons for ineligibility were referral after 26 weeks of gestation, miscarriage, and patient denial of smoking in past week.’ Women who miscarried were excluded post randomisation.


InterventionsIntervention group: (220 women) best practice care (mailed pregnancy tailored smoking cessation booklet) and care providers sent ACOG smoking cessation guideline and reminder to address smoking at participants’ visits and a brief telephone call by a trained counsellor of about 5 minutes to discuss smoking, In addition women in the intervention group received a series of phone calls  and additional mailed material. Each women had a counsellor offering up to 90 minutes of phone counselling during pregnancy and 15 minutes in the postpartum period. The counselling was tailored to women’s readiness to quit and focused on encouraging smoking reduction or quitting using motivational interviewing or cognitive behavioural strategies to increase sense of self-efficacy and social support. Participants received a mean of 5 calls (range 0-20) on average 4 during pregnancy (total duration mean 63 minutes) and 1 postpartum (mean 5 minutes).

Control group: (222 women) best practice care (mailed pregnancy tailored smoking cessation booklet) and care providers sent ACOG smoking cessation guideline and reminder to address smoking at participants’ visits and a brief telephone call by a trained counsellor of about 5 minutes to discuss smoking; smokers who requested further help were referred to a 'quitline'.


OutcomesCotinine-validated and self-report quit rates at late pregnancy (after 28 weeks) and at 3 months postpartum. Women also reported number of attempts at quitting and reduction of 50% in number of cigarettes smoked.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskWomen were assigned to treatment conditions using a computer-generated randomisation list arranged in balanced blocks of 4 and stratified by referral source (Tufts Health Plan versus community practice).

Allocation concealment (selection bias)Low risk ‘The list was contained in the computer-assisted interviewing application used for the study and accessible only to the application’s developer. Counselors could not view the list; the application revealed the next assignment only after the smoker had consented to participate in the study.'

Blinding of participants and personnel (performance bias)
All outcomes
High riskWomen and counsellors would be aware of intervention.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskResearch assistants rather than counsellors collected self-report data at telephone follow-up (it was not clear whether they would be aware of randomisation group). Self-report of quitting was validated by mailed saliva samples for cotinine analysis (low risk for outcome detection bias for primary outcome).

Incomplete outcome data (attrition bias)
All outcomes
Low riskFor the primary outcome there was an ITT analysis with those women not followed up or not mailing saliva samples assumed to be still smoking. Only 23 women who had miscarried were excluded from this analysis.

Selective reporting (reporting bias)Unclear riskAssessment from published study paper.

Other biasUnclear riskSome baseline imbalance:  ‘Partner smokes’ (borderline significantly more in Intervention group than in control) and ‘Made quit attempt in this pregnancy’(more in Intervention group than in control) ‘Nulliparous’ (borderline significantly more in Intervention group than in control) and weeks in gestation (borderline significantly higher in Intervention group than in control, support for quitting from partner more in Intervention group than in control).

Simonetti 2012

MethodsRCT, 2 arms with individual randomisation.


ParticipantsSetting: 114 primiparous women delivering in an Italian maternity ward in 2 months in 2009.

Inclusion criteria: healthy primiparous women intending to breastfeed.

Exclusion criteria:  women with preterm or low birthweight babies, or with baby admitted to NICU or women with any condition that may impede breastfeeding.


InterventionsIntervention group: 55 women. Women received telephone calls during the first 6 weeks postpartum at least weekly. The calls were to provide information on breastfeeding, promote exclusive breastfeeding and to discuss any problems.

Control group: 59 women received usual care which involved visits to the doctor at 1, 3 and 5 months postpartum.

Both groups received breastfeeding education as part of routine antenatal care.


OutcomesExclusive breastfeeding at 1, 3 and 5 months following delivery.


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot described.

Allocation concealment (selection bias)Unclear risk"randomly assigned."

Blinding of participants and personnel (performance bias)
All outcomes
High riskNot mentioned. Women and staff would be aware of the intervention.

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot mentioned.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk114 women were enrolled. It was stated that 4 women in the intervention group were excluded post randomisation as they did not meet inclusion criteria (it was not clear when women were randomised).

Selective reporting (reporting bias)Unclear riskAssessment from published study report.

Other biasUnclear riskThere did not appear to be differences between the groups at baseline. The description of study methods was very brief.

Smith 2008

MethodsRCT, 3 arms with individual randomisation.


Participants840 women randomised 536 randomised to arms included in analysis in this review. Low-risk nulliparous women. Setting not described (UK). Women recruited between 2004-2007.

Inclusion criteria: Low-risk nulliparous women.


Interventions3-arm trial. We have used data for groups 1 and 2 only in this review.

  1. Control (283 women) standard care (not described).
  2. Telephone call from a midwife at 28, 33 and 36 weeks (282 women).
  3. Telephone calls plus additional uterine artery Doppler screening (275 women).


OutcomesNumber of scheduled and unscheduled visits to clinic, STAI at 36 weeks and 6 weeks postpartum. Satisfaction with antenatal care. Other outcomes included social support, pre-eclampsia and infant birthweight.


NotesAdditional unpublished data were provided by the author.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskAuthor reported that sequence generation was by a web-based computer package.

Allocation concealment (selection bias)Unclear riskNot described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskNo blinding.

Blinding of outcome assessment (detection bias)
All outcomes
High riskNo blinding.

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk41/565 (7%) lost to follow-up but there were high levels of missing data for some outcomes. Analysis according to randomised group although many women in the telephone support group did not receive the intervention as planned.

Selective reporting (reporting bias)Low riskBrief conference abstract, additional information provided by the author.

Other biasUnclear riskMany of the women in the telephone support group did not receive the intervention as planned. (28.7% received all three scheduled calls, 30.1% 2 calls, 22.3% 1 call and 18.8% none of the planned calls).

Stotts 2002

MethodsRCT. 2-arm trial with individual randomisation.


Participants269 women (134 in intervention and 135 in control)

Setting: ‘The sample was drawn from 21 satellite locations of three large multispecialty clinics in the Houston and Dallas metropolitan areas’.

Inclusion criteria: current smokers at 28 weeks. Reported as ‘Preliminary eligibility was based on fluency in English, age (18 years or older), smoking frequency (at least 5 cigarettes per week prior to pregnancy), and gestational age at first prenatal visit (before or at 20 weeks)’.  

Exclusion criteria: non-smokers and ex-smokers.


Interventions1-to-1 intervention group. (134 women) Usual care plus 5 newsletters and a video for women and their partners on healthy behaviours (including weight loss and smoking). Newsletters mailed at 2-week intervals from 39th-40th week (i.e. mainly postnatal). Women also received one 20-30 minute telephone counselling call using motivational interviewing strategies within 2 weeks of the 28 weeks’ assessment. They were then mailed a personal feedback letter and then a second telephone counselling intervention was carried out  a few days later. Counselling by trained nurse educators.

The control group (135 women). Usual care included a 3-5 minute counselling session on smoking cessation in pregnancy and were given the first in a series of self-help booklets at 28 weeks. The remaining 7 booklets in the series were mailed to women weekly thereafter. (It was not clear whether women in the control group also received the video and more general pregnancy information; we have contacted the author for more information.)


OutcomesReported as ‘Data for the present study were collected at the first prenatal visit (intake), during the 28th and 34th weeks of pregnancy, and 6 weeks and 3 and 6 months postpartum’.

34th week cotinine testing, and postpartum telephone interviews conducted at 6 weeks and 3 and 6 months for reported smoking behaviour (quit or “light” smoking).


NotesRaw data were not reported for most outcomes. We have contacted the author for more information and are awaiting a response. Cotinine data for a subset only. Very high attrition. Data from this study have not been included in the data and analysis tables.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated random number list.

Allocation concealment (selection bias)Unclear riskNot described.

Blinding of participants and personnel (performance bias)
All outcomes
High riskMost outcomes are self-reported. Women and care providers were not blind to intervention.

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskUrine samples were collected anonymously on 175 of the 269 randomised women during clinic visits and analysed for cotinine. The only markers attached to the cotinine samples were a coded ID number that indicated experimental group status and the amount of intervention received. These women (Intervention n = 84; Control n = 82) represent the Anonymous Cotinine Subsample.’. High risk of detection bias for self-report outcomes.

Incomplete outcome data (attrition bias)
All outcomes
High riskUrine samples were collected on only 175 of the 269 randomised women (40%).   

Postpartum follow-up subsample: These analyses were performed on those who consented to the postpartum follow-up study (n = 166) and not the total randomised sample (62% followed up).

No ITT analysis. Much of the analysis was for women who had received all or part of the intervention (62% of the experimental group).

Selective reporting (reporting bias)High riskNo ITT analysis and outcomes were reported in the postpartum period for light as well as non-smokers (not smoking most of the time but have a few puffs now and again – not clear what this means). It was reported that very few women reported no smoking at 6 weeks, 3 and 6 months pp (12,11, and 11 women not reported by randomisation group).

Other biasUnclear riskInitial comparisons of demographic variables revealed no differences between the experimental and control groups’. However, table 2 reveals a significant difference on Smoking before pregnancy (No. of cigarettes per week) –  there is a higher incidence of smoking more than 61 a week in the intervention group. Figures on reported smoking in the postnatal period were adjusted for baseline behaviour. (Not clear how this was done.)

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Alemi 1996Both intervention and control groups received telephone support.

Bartholomew 2011This study describes 2 methods of blood glucose monitoring in pregnancy; telephone reporting is compared with a new methods involving plugging the glucometer into a cell telephone which relays results to a website for clinical staff to review. There is no support intervention.

Brooten 1994The purpose of the study was to examine the average time nurses spent planning for early hospital discharge and providing home care to women who delivered by unplanned caesarean birth, therefore excluded.

Brooten 2001Telephone support is only a small component of the intervention (prenatal care in the women's homes which included teaching, counselling, telephone outreach, daily telephone availability, postpartum home visit by nurse specialist with physician backup). The study was excluded as the intervention included other elements as well as telephone support and therefore results may be misleading.

Caramlau 2011Publication is a trial protocol.

Chen 1993Randomisation alternate allocation (in order of woman's availability to join trial) therefore excluded.

Dennis 2003The study included women randomised to the intervention between 8 and 12 weeks postpartum, therefore excluded.

Edwards 1997The study included women randomised to the intervention 3 months postpartum, therefore excluded.

Ershoff 2000This was a quasi-experimental historical design study and therefore excluded.

Fjeldsoe 2010The study included women randomised to the intervention up to 12 months postpartum, therefore excluded.

Frank 1986Telephone support is only a small component of the intervention - single telephone contact at 4 months. The study was excluded as the intervention included other elements as well as telephone support and therefore results may be misleading.

Gagnon 2002All women received telephone support (nurse telephone contact at 48 hours post birth), women were then randomised to nurse visit at 3 to 4 days postpartum in either the woman's home by the community nurse (intervention) or by the hospital nurse in the hospital clinic (control).

Gjerdingen 2009This study was excluded as the intervention included several elements as well as telephone support, and the intervention mainly took place after 6 weeks postpartum. The trial focused on women screened as being at high risk of postnatal depression during a well-child clinic visit. Women were recruited at up to a month postpartum and the intervention began within 1 or 2 weeks and continued up to 9 months (i.e. the intervention predominantly took place after 6 weeks postpartum). The intervention was complex and included referral to the primary care provider with a recommendation for treatment either with anti-depressants and/or referral for psychotherapy. Care professionals received decision-support and educational materials. Women were followed up by telephone by a case manager. Women also received educational material. Women in the control group were informed of the depression diagnosis and referred to their primary care provider for usual care (at the discretion of the care provider).

Haider 1997Telephone calls were not the intervention.

Iams 1988Both intervention and control groups received telephone support.

Jang 2008This was a quasi-experimental study and therefore excluded.

Janssen 2006The study aimed at evaluating telephone (the current standard of care) with home-based triage. Triage comprised advice (either over the telephone or at home) as to when to come into hospital at term. The study was excluded as the intervention compared two types of triage.

Katz 2011This study examined a complex intervention aimed at adolescent and teenaged pregnant women. The intervention started early in pregnancy and continued for 18 months postpartum (i.e. the intervention predominantly occurred after pregnancy). The intervention included a range of approaches including telephone support, provision of written materials, face-to-face meetings with a counsellor and lunchtime meetings every 3 months throughout the intervention period. The study was excluded as the intervention included other elements as well as telephone support.

Kersten-Alvarez 2010The study included women randomised to the intervention on average 6 months postpartum. therefore excluded.

Lando 2001This was a quasi-experimental effectiveness study and therefore excluded.

Langer 1993Telephone calls were not the intervention.

Lewis 2011The purpose of this study was to evaluate strategies for recruiting pregnant postpartum women into trials.

Norbeck 1996Telephone support is only a small component of the intervention - social support intervention (4 standard face-to-face sessions 1- interview providing support on three problem areas; 2- video-tape; 3 and 4 - focused on relationships that foster self-esteem. Sessions occurred approximately every 2 weeks and telephone contact was maintained in between). The study was excluded as the intervention included other elements as well as telephone support and therefore results may be misleading.

Oakley 1990Telephone support is only a small component of the intervention - social support intervention (3 home visits carried out 14, 20 and 28 weeks' gestation, plus 2 telephone contacts or brief home visits in between those times, midwives on-call to the mothers 24 hours/day, semi-structured interviews to provide a basis for flexible and open-ended communication between midwives and mothers, midwives provided topic specific information to mothers) The study was excluded as the intervention included other elements as well as telephone support and therefore results may be misleading.

Rush 1991No clinical outcomes reported. Trial evaluated the frequency of use of a hospital telephone line for new parents.

Sink 2001Telephone calls were not the intervention.

Steel O'Conner 2003The study examined postpartum home visits or screening telephone call. The telephone intervention comprised of a screening call to new mothers on the first day following discharge from hospital. The content of the call was structured to elicit the mothers concerns in the areas of infant feeding, her baby's general health and her emotional status. A home visit was made if either the mother or clinician identified a need. The study was excluded a the telephone calls were used as a screening tool.

Stomp-van den Berg 2007Publication is a trial protocol.

van Doesum 2008The study included women randomised to the intervention up to 12 months postpartum, therefore excluded.

 
Characteristics of ongoing studies [ordered by study ID]
Dennis 2012

Trial name or titleThe effect of telephone-based interpersonal psychotherapy for treatment of postpartum depression.

MethodsRCT. 2 arms. Individual randomisation.

Participants240 women between 2 and 24 weeks postpartum with a diagnosis of major depression.

InterventionsStandard care plus telephone-based interpersonal psychotherapy by a trained nurse (12 sessions) compared with standard care alone.

OutcomesPostpartum depression, depressive symptomatology, anxiety, couple adjustment and health service use.

Starting date212 participants enrolled by March, 2012.

Contact informationCindy-Lee Dennis cindylee.dennis@utoronto.ca

Notes

Evans 2012

Trial name or titleThe Text4baby case study.

MethodsPilot RCT.

ParticipantsPregnant women attending for first prenatal care appointment. Planned recruitment 249 women.

InterventionsUsual care plus mobile phone text messages during pregnancy and the postnatal period (general health promotion, healthcare utilisation, nutrition, smoking, 130 prenatal messages and similar number for the postnatal period) compared with usual care alone.

OutcomesGestational age at delivery, antenatal hospital admissions, attendance at antenatal care, body mass index, weight gain in pregnancy, infant birthweight.

Starting dateNot clear, planned completion of recruitment "late 2012".

Contact informationwdevans@gwu.edu

Notes

Moniz 2012

Trial name or titleInfluenza and text messaging in pregnancy.

MethodsRCT, 2 arms with individual randomisation.

ParticipantsEstimated recruitment 250 women less than 28 weeks' gestation aged between 14-50 and willing to receive text messages and no contraindications to receiving the influenza vaccine.

InterventionsText messages re general health in pregnancy plus messages on influenza vaccination from enrolment until delivery compared with text messages on general health alone.

OutcomesInfluenza vaccination uptake and knowledge re influenza in pregnancy.

Starting dateSeptember 2010.

Contact informationMichelle Moniz, University of Pittsburgh, USA.

Notes

Patel 2011

Trial name or title"Effectiveness of cell phone couseling to improve breast feeding indicators."

MethodsCluster-randomised trial.

Participants1036 women between 32-36 weeks' gestation attending antenatal clinic at 2 hospitals serving socio-economically disadvantaged women in India.

InterventionsBreastfeeding counselling by phone starting during pregnancy and up to 6 months postpartum compared with hospital counselling.

OutcomesExclusive breastfeeding up to 26 weeks postpartum, infant hospitalisation, immunisation uptake.

Starting dateJanuary 2010.

Contact informationdr_apatel@yahoo.com

Notes

 
Comparison 1. Telephone support versus any other supportive intervention, or no telephone support

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Maternal satisfaction with support during pregnancy2132Std. Mean Difference (IV, Fixed, 95% CI)1.16 [0.79, 1.54]

 2 Maternal satisfaction with support in postnatal period (number feeling they were not supported)1181Risk Ratio (M-H, Fixed, 95% CI)0.84 [0.43, 1.64]

 3 Maternal satisfaction with support in postnatal period2119Std. Mean Difference (IV, Fixed, 95% CI)0.54 [0.17, 0.91]

 4 Maternal anxiety in pregnancy2386Std. Mean Difference (IV, Fixed, 95% CI)-0.09 [-0.29, 0.11]

 5 Maternal anxiety (number of women with anxiety) at last postpartum assessment2702Risk Ratio (M-H, Random, 95% CI)0.50 [0.17, 1.46]

 6 Maternal anxiety in postnatal period3952Std. Mean Difference (IV, Fixed, 95% CI)-0.15 [-0.27, -0.02]

 7 Parenting stress: high score on parenting stress index at 12 weeks postpartum194Risk Ratio (M-H, Fixed, 95% CI)0.30 [0.09, 1.00]

 8 General health: general health at 8 weeks postpartum rated as good or very good137Risk Ratio (M-H, Fixed, 95% CI)0.93 [0.72, 1.21]

9 Mortality and serious morbidity00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 10 Health service utilisation: mean number of antenatal visits2563Mean Difference (IV, Fixed, 95% CI)0.24 [-0.26, 0.74]

 11 Health service utilisation: admission to hospital during pregnancy1554Risk Ratio (M-H, Fixed, 95% CI)1.61 [0.95, 2.75]

 12 Health service utilisation: maternal length of hospital stay142Mean Difference (IV, Fixed, 95% CI)0.81 [-1.56, 3.18]

 13 Health service utilisation up to 8 weeks postpartum (mean contacts)1Mean Difference (IV, Fixed, 95% CI)Subtotals only

    13.1 Contacts with community midwife
158Mean Difference (IV, Fixed, 95% CI)-0.40 [-1.46, 0.66]

    13.2 Contacts with health visitor
158Mean Difference (IV, Fixed, 95% CI)-0.5 [-1.33, 0.33]

 14 Health service utilisation in postnatal period (last assessment up to 6 months) Mean number of contact1600Mean Difference (IV, Fixed, 95% CI)-0.03 [-0.28, 0.22]

 15 Postnatal depression: clinical diagnosis of depression at 3 months postpartum1612Risk Ratio (M-H, Fixed, 95% CI)0.65 [0.34, 1.23]

 16 Postnatal depression symptoms (high risk on scale) at 3 months postpartum2701Risk Ratio (M-H, Fixed, 95% CI)0.51 [0.37, 0.70]

 17 Postnatal depression symptoms (mean score on EPDS) at 3 months postpartum1612Mean Difference (IV, Fixed, 95% CI)-0.96 [-1.75, -0.17]

 18 Positive behaviour change: stopped smoking by the end of pregnancy (cotinine validated)41361Risk Ratio (M-H, Fixed, 95% CI)1.12 [0.87, 1.44]

 19 Positive behaviour change: stopped/not smoking by the end of pregnancy (self-report)41638Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.95, 1.23]

 20 Positive behaviour change: stopped smoking at last postpartum assessment (cotinine validated)2949Risk Ratio (M-H, Fixed, 95% CI)0.90 [0.62, 1.32]

 21 Positive behaviour change: stopped smoking at last postpartum assessment (self-report)2670Risk Ratio (M-H, Fixed, 95% CI)1.28 [0.94, 1.73]

 22 Any breastfeeding at up to 6 weeks postpartum5735Risk Ratio (M-H, Random, 95% CI)0.98 [0.86, 1.12]

 23 Any breastfeeding up to 6 months postpartum5691Risk Ratio (M-H, Fixed, 95% CI)1.21 [1.06, 1.38]

 24 Exclusive breastfeeding at 4-8 weeks4465Risk Ratio (M-H, Random, 95% CI)1.27 [0.88, 1.83]

 25 Exclusive breastfeeding at 3 -6 months3411Risk Ratio (M-H, Fixed, 95% CI)1.51 [1.19, 1.93]

 26 Mean breastfeeding duration (any breastfeeding) in days199Mean Difference (IV, Fixed, 95% CI)7.60 [0.06, 15.14]

 27 Positive behaviour change: not drinking in the last month (late pregnancy)1122Risk Ratio (M-H, Fixed, 95% CI)0.95 [0.75, 1.20]

 28 Positive behavioural change: women meeting postpartum weight goals at 6 months postpartum1189Risk Ratio (M-H, Fixed, 95% CI)1.20 [0.67, 2.17]

 29 Preterm birth < 37 weeks43992Risk Ratio (M-H, Fixed, 95% CI)0.91 [0.77, 1.08]

 30 Mean gestational age at delivery142Mean Difference (IV, Fixed, 95% CI)0.0 [-1.49, 1.49]

 31 Low birthweight < 2500 g33862Risk Ratio (M-H, Fixed, 95% CI)0.90 [0.76, 1.07]

 32 Mean birthweight2592Mean Difference (IV, Fixed, 95% CI)-42.11 [-130.36, 46.14]

33 Infant developmental measures00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 34 Neonatal/infant mortality.11884Risk Ratio (M-H, Fixed, 95% CI)1.40 [0.82, 2.42]

 35 Major neonatal/infant morbidity/admission to NICU22403Risk Ratio (M-H, Fixed, 95% CI)0.71 [0.52, 0.97]

 36 Non-prespecified: infant length of hospital stay142Mean Difference (IV, Fixed, 95% CI)0.80 [-0.31, 1.91]

 37 Non prespecified: mean number of infant healthcare visits141Mean Difference (IV, Fixed, 95% CI)-1.4 [-2.57, -0.23]

 38 Non prespecified outcome: satisfaction with infant feeding experience1256Mean Difference (IV, Fixed, 95% CI)0.83 [-0.60, 2.26]

 39 Caesarean section32480Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.90, 1.24]

 40 Non prespecified outcome: diagnosis of preterm labour142Risk Ratio (M-H, Fixed, 95% CI)1.0 [0.50, 2.01]

 
Comparison 2. Verbal telephone support versus text support

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

1 Maternal satisfaction with support during pregnancy and the first six months postpartum00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

2 Maternal anxiety00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

3 Mother-infant attachment00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

4 General health00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

5 Mortality and serious morbidity00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

6 Health service utilisation00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

7 Postpartum depression00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

8 Positive behaviour change00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

9 Preterm birth/low birthweight00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

10 Breastfeeding duration00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

11 Infant developmental measures00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

12 Neonatal/infant mortality.00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

13 Major neonatal/infant morbidity00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

14 Intervention cost00Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Table 1. Mobile phone intervention and skilled attendance at the birth

OUTCOMEIntervention (Total 1311 women)Control (Total 1239 women)Adjusted Odds Ratio (OR)

Skilled attendant at the birth (all)

Unadjusted data
766 (60%)560 (47%)

Skilled attendant at the birth (rural residence)

OR adjusted to take account of cluster-design effect
317 (43%)313 (44%)0.85 (95% CI 0.42 to 1.71)

Skilled attendant at the birth (urban residence)

OR adjusted to take account of cluster-design effect
449 (82%)247 (50%)5.73 (95% CI 1.51 to 21.81) P < 0.01

 CI: confidence interval