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Routine pre-pregnancy health promotion for improving pregnancy outcomes

  1. Melissa Whitworth1,*,
  2. Therese Dowswell2

Editorial Group: Cochrane Pregnancy and Childbirth Group

Published Online: 7 OCT 2009

Assessed as up-to-date: 27 FEB 2009

DOI: 10.1002/14651858.CD007536.pub2


How to Cite

Whitworth M, Dowswell T. Routine pre-pregnancy health promotion for improving pregnancy outcomes. Cochrane Database of Systematic Reviews 2009, Issue 4. Art. No.: CD007536. DOI: 10.1002/14651858.CD007536.pub2.

Author Information

  1. 1

    St Mary's Hospital, Manchester, UK

  2. 2

    The University of Liverpool, Cochrane Pregnancy and Childbirth Group, School of Reproductive and Developmental Medicine, Division of Perinatal and Reproductive Medicine, Liverpool, UK

*Melissa Whitworth, St Mary's Hospital, Central Manchester and Manchester Children's University Hospitals NHS Trust, Hathersage Road, Manchester, M13 0JH, UK. mkw@doctors.org.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 7 OCT 2009

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Characteristics of included studies [ordered by study ID]
Elsinga 2006

MethodsCluster-randomised trial carried out in the Netherlands (unit of randomisation was GP practices).


ParticipantsWomen aged 18 to 40 years attending for care with 67 GPs (in 54 GP practices).

There were a total of 27,226 women aged between 18 and 40 years attending the 30 intervention practices during the 3-year study period (it was not clear what the figure was for control practices; information on the 37 control practices and women attending these practices was not provided in the study publications).

In the intervention practices, GPs excluded 12,306 (45%) of women on grounds of completed family, infertility or sterility, inability to understand Dutch, or adverse family circumstances.

Of 14,915 women offered preconception care, 45% responded (6782). Of these 1820 (27%) intended to get pregnant within the next 5 years. 348 women attended for preconception counselling over the 3-year study period (representing 1.3% of the women in the relevant age group eligible for the study intervention). Results reported in study publications relate to those women attending for care.


InterventionsIntervention group: women were asked to express an interest in pre-conception care. Those expressing interest were sent a risk assessment questionnaire and invited to attend with their partner for pre-conception care provided by their GP. Advice addressed both general risk factors and specific advice on risks identified from the risk assessment questionnaire.

Control group: women received routine care (no routine invitation to attend for pre-conception care).


OutcomesKnowledge, anxiety, pregnancy rates, changes in lifestyle and behaviour to reduce pregnancy risk factors (folic acid use, alcohol, smoking, infection, exposure to hazardous substances).


NotesThanks to Dr Elsinga for providing helpful additional information about the study.

The analyses for this trial were not carried out by randomisation group. Women in the intervention group who attended for pre-conception care (a small proportion of the eligible age group) were matched with women attending for routine care. Information is not available on the whole randomised sample. We have been unable to include the data from the trial in the analyses in this review.


Risk of bias

ItemAuthors' judgementDescription

Adequate sequence generation?UnclearCluster randomisation. Randomisation was stratified.

Allocation concealment?UnclearNot described.

Blinding?
Clinical staff
NoIt is not feasible to blind clinical staff to this type of intervention.

Blinding?
Participants
NoEducational intervention.

Blinding?
Outcome assessors
UnclearMost analyses were not according to randomisation group. It may have been possible to blind outcome assessors to group allocation for some outcomes.

Incomplete outcome data addressed?
All outcomes
NoLarge numbers of women were excluded from the intervention group by their GP both before and after the intervention. Response rates were low and attendance for care was low.

Free of selective reporting?NoDue to low attendance for care, an ITT analysis was not performed. Rather, women in the intervention group who had attended for care were matched with women from the comparison group. Figures on outcomes were not available for all women randomised who became pregnant during the study period.

Floyd 2007

MethodsRCT.


Participants830 women aged 18-44 capable of becoming pregnant and who had had sexual intercourse in the previous 3 months without contraception, who were not pregnant or planning pregnancy at the time of the intervention and who were "risky" drinkers (defined as have had 8 drinks per week or more than 5 drinks on 1 occasion).

Setting: community-based settings including primary care practices, hospital clinics, prisons and drug and alcohol treatment centres in the USA. Recruitment between 2002-4. (Project CHOICES).


InterventionsThe aim of the intervention was to reduce the number of alcohol-exposed pregnancies by encouraging women to avoid risky drinking or to use contraception, or both.

Intervention: motivational interviews by trained counsellors. Women attended 4 sessions (approximately 1 hour each) and were given advice on reducing alcohol, with personalised feedback and goal setting. Women also received an appointment with a healthcare provider to discuss contraception. 63% of the sample attended all 4 counselling sessions.

Comparison group: written information on alcohol risks and women's health.

Both groups were assessed at baseline and at 3, 6 and 9 months following the intervention. Women were reimbursed for the time taken to complete assessments or to attend counselling sessions and for travel expenses.


OutcomesAlcohol use (< 7 drinks per week or < 5 drinks on any 1 occasion).

Risk of alcohol exposed pregnancies (risky drinking and no contraception).


NotesA number of women in the sample were recruited from alcohol treatment centres. We had intended to exclude studies recruiting women actively participating in alcohol treatment programmes. In the context of the study, such women formed part of a larger sample mainly recruited from other community-based settings and we decided to include this study.


Risk of bias

ItemAuthors' judgementDescription

Adequate sequence generation?YesComputer generated (some block randomisation in some recruitment centres).

Allocation concealment?YesSealed, opaque, sequentially numbered envelopes.

Blinding?
Clinical staff
NoNot feasible.

Blinding?
Participants
NoNot feasible.

Blinding?
Outcome assessors
UnclearFollow up was conducted by staff unaware of group allocation.

Incomplete outcome data addressed?
All outcomes
Unclear830 women were randomised. 237 were lost to follow up (29% attrition). There was further loss at longer-term follow up. It was possible to include all women randomised in an ITT analysis by assuming that behaviour did not change in women lost to follow up.

Free of selective reporting?UnclearNot apparent.

Free of other bias?YesNo baseline imbalance was apparent. Analysis was conducted to take account of attrition and recruitment setting.

Jack 1998

MethodsRCT.


Participants170 women recruited and assessed (it was not clear how many women were randomised to intervention and control groups).

Inclusion criteria: women with negative pregnancy test results enrolled by a nurse experienced in prenatal risk assessment.

Exclusion criteria: women who had had a pregnancy test as part of a specific medical assessment (e.g. for abdominal pain).


InterventionsAll women completed a preconception risk survey to identify medical, psychosocial and behavioural risk factors.

Intervention group: women and clinical staff caring for them were notified about risk factors identified; women received a booklet on reducing risks before pregnancy and were offered an appointment with their primary care doctor to discuss them. Primary care doctors received a letter describing the findings of the assessment and asked to initiate interventions or treatment to address risks and to document actions.

Routine care: no feedback on the assessment was provided.


OutcomesRisk factors (e.g. alcohol use, infection, nutrition) identified and addressed by interventions.


NotesThanks to Dr Jack for providing the review team with helpful additional information about this study.

Analysis in this study was carried out for a subgroup of women who had attended for care in the year following the initial assessment (100 women). Findings were not available for all women randomised.


Risk of bias

ItemAuthors' judgementDescription

Adequate sequence generation?UnclearA coin was tossed by the enrolling nurse (it was not clear at what stage in the recruitment process the coin was tossed).

Allocation concealment?NoIt would be possible for the enrolling nurse to change group allocation.

Blinding?
Clinical staff
NoPrimary care doctors were informed of risk assessment.

Blinding?
Participants
NoEducation and advice intervention.

Incomplete outcome data addressed?
All outcomes
UnclearData on most outcomes were only available for those women attending for care in the year following assessment.

Free of selective reporting?UnclearMost of the analyses was for a subgroup of women who attended for care.

Lumley 2006

MethodsRCT.


ParticipantsSetting: study in Melbourne, Australia in a newly established pre-pregnancy walk-in service.

1579 women randomised (786 included in analysis). The aim was to recruit women at higher risk of poor pregnancy outcomes including recent migrants, lone parents and women with low incomes. An interpreter was available.

Inclusion criteria: women attending government funded maternal and child health centres after the birth of their first child living in designated areas.

Exclusion criteria: women attending for specialist care (for example, after the death of their first child).


InterventionsIntervention group: home visit by pre-pregnancy midwife to discuss first pregnancy, labour, etc and to answer questions. In addition, midwife counselling including identification of risk factors (genetic, social, health or lifestyle) and timing and preparation for next pregnancy. Offer of referral for problems identified (e.g. to dietician or genetic services). Arrangements for rubella immunisation, advice on smoking and medication.

Comparison group: home visit by pre-pregnancy midwife to discuss first pregnancy and to answer questions. No active counselling intervention.


OutcomesPrimary outcomes: low birthweight, gestational age at birth, preterm birth, perinatal deaths and birth defects.

Interval between pregnancies (not pre-specified).


Notes


Risk of bias

ItemAuthors' judgementDescription

Adequate sequence generation?YesRandom number tables, balanced block randomisation.

Allocation concealment?UnclearNot described. Allocation occurred before the midwife delivering the intervention met the women recruited.

Blinding?
Clinical staff
UnclearState that usual caregivers were blind to group allocation.

Blinding?
Participants
NoNot feasible.

Blinding?
Outcome assessors
No

Incomplete outcome data addressed?
All outcomes
No1579 women randomised. 176 became ineligible before the start of the trial. Of the remaining 1403 women there was further attrition (44%). 364 (26%) women were lost to follow up and 253 (18%) did not become pregnant during the study period. For the 786 women included in analyses there were low levels of missing data.

(As part of this review we have carried out a sensitivity analysis where we attempted to include all women potentially eligible for that outcome, so we have added those women failing to become pregnant (but not lost to follow up) to the denominators of the study groups.)

Free of other bias?YesNot apparent.

Robbins 2005

MethodsRCT.


Participants322 women randomised aged 18-45 years, capable of becoming pregnant, attending routine gynaecology clinics. Approximately 12% of the sample were planning pregnancy within the next year and 60% at some stage in the future.

Exclusion criteria: women who were already pregnant or specifically attending for preconception or non-routine care. Women who could not speak English or who had had hysterectomy, tubal ligation or a previous NTD pregnancy.


InterventionsIntervention group: brief counselling (approximately 1 minute) specifically about folic acid use by gynaecologist, pamphlet on benefits of folic acid and starter bottle of folic acid tablets. Follow-up phone call reinforcing the message 1-2 weeks later. (160 women.)

Comparison group: routine brief counselling on health issues (e.g. breast examination, seat belt and sunscreen use. The advice could include information on folic acid depending on the usual practice of the clinician) and voucher for folic acid (which could be redeemed by posting off the voucher) (162 women).

Groups were followed up after 2 months.


OutcomesWeekly and daily folic acid use.


NotesThe author kindly provided additional unpublished data for inclusion in the review.


Risk of bias

ItemAuthors' judgementDescription

Adequate sequence generation?UnclearDescribed as permuted block method. Block size specified - 10.

Allocation concealment?UnclearDescribed as "assigned randomly".

Blinding?
Clinical staff
NoNot feasible.

Blinding?
Participants
NoNot feasible.

Incomplete outcome data addressed?
All outcomes
UnclearData available for 279 of 322 randomised (attrition 13%).

Velott 2008

MethodsRCT (individual randomisation).


ParticipantsSetting: 15 low-income rural communities in Pennsylvania (USA) (The Central Pennsylvania Women's Health Study). Women in the area reported high levels of risk for obesity, poor nutrition, depression, alcohol use, smoking, infection and psycho-social stress.

Inclusion criteria: non-pregnant pre- and inter-conceptional women aged 18-35 who were capable of becoming pregnant.

Exclusion criteria: women who were known to be infertile (e.g. following hysterectomy or sterilisation).


Interventions362 women followed up (692 randomised, 2:1 intervention: control ratio).

All women completed baseline risk assessment and women with blood pressure, cholesterol or other bio-physical markers outside the normal range were referred to healthcare providers.

Intervention: group education addressing pregnancy and conception, managing stress, improving health through lifestyle changes and preventing infection. Women attended 6 2-hour sessions over a 12-week period, with "buddy" mutual support and home work.

Comparison group: no active intervention.

Women received gift voucher incentives to attend intervention sessions and assessments. Women were followed up 14 weeks after the baseline assessment.


OutcomesAttitudes, self-reported behaviour (e.g. physical activity, use of multi-vitamins and folic acid, alcohol use and smoking), cholesterol and blood pressure and other physical measurements.


NotesThere was some baseline imbalance between intervention and control groups at baseline and at follow up.

The authors provided additional, helpful, unpublished information on the study to the review team.


Risk of bias

ItemAuthors' judgementDescription

Adequate sequence generation?UnclearNot clear.

Allocation concealment?UnclearNot clear.

Blinding?
Clinical staff
NoNot feasible, educational intervention.

Blinding?
Participants
No

Blinding?
Outcome assessors
UnclearThose carrying out physical assessments were described as "blind" to the treatment condition.

Incomplete outcome data addressed?
All outcomes
NoThere were high levels of attrition in both the intervention and control groups (48%) at follow up. Post-test data were not available for women lost to follow up.

Free of selective reporting?UnclearNone apparent.

Free of other bias?UnclearDifferent methods were used in the 15 participating communities to recruit women. It was not clear whether this affected follow up.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Prunty 2008This study focuses on women with multiple sclerosis and examines decision-aid materials to assist women in deciding whether to become pregnant. There was no health promotion intervention to improve pregnancy outcomes.

 
Comparison 1. Pre-pregnancy intervention versus routine care

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

 1 Baby small-for-gestational age (< 10th percentile)1760Risk Ratio (M-H, Fixed, 95% CI)1.30 [0.83, 2.04]

 2 Extremely preterm birth (less than 28 weeks)1781Risk Ratio (M-H, Fixed, 95% CI)9.02 [0.49, 167.03]

 3 Preterm birth (less than 37 weeks)1781Risk Ratio (M-H, Fixed, 95% CI)1.42 [0.77, 2.59]

 4 Birthweight less than 2500 g1787Risk Ratio (M-H, Fixed, 95% CI)1.79 [0.94, 3.39]

 5 Congenital anomaly1786Risk Ratio (M-H, Fixed, 95% CI)2.51 [0.49, 12.87]

 6 Mean birthweight1781Mean Difference (IV, Fixed, 95% CI)-97.0 [-168.05, -25.95]

 7 Maternal behaviour change: daily folic acid use (all women)2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    7.1 Very brief counselling
1279Risk Ratio (M-H, Fixed, 95% CI)1.09 [0.80, 1.47]

    7.2 More intensive intervention
1356Risk Ratio (M-H, Fixed, 95% CI)1.92 [1.49, 2.46]

 8 Maternal behaviour change: daily folic acid use (women planning pregnancy in next year)135Risk Ratio (M-H, Fixed, 95% CI)1.06 [0.68, 1.66]

 9 Maternal behaviour change: less than 8 alcoholic drinks per week at 9 months follow up1593Risk Ratio (M-H, Fixed, 95% CI)1.25 [1.06, 1.47]

 10 Maternal behaviour change: less than 8 alcoholic drinks per week (ITT analysis)1830Risk Ratio (M-H, Fixed, 95% CI)1.20 [0.99, 1.44]

 11 Maternal behaviour change: no more than 5 drinks on any 1 day (9 months follow up)1593Risk Ratio (M-H, Fixed, 95% CI)1.24 [1.06, 1.44]

 12 Maternal behaviour change: no more than 5 drinks on any 1 day (ITT analysis)1830Risk Ratio (M-H, Fixed, 95% CI)1.19 [0.99, 1.42]

 13 Maternal behavioural change: consuming alcohol at follow up1358Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.89, 1.30]

 14 Maternal behaviour change: consumed alcohol on 10 or more days in the last month1358Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.46, 2.27]

 15 Maternal behavioural change: smoking at follow up1360Risk Ratio (M-H, Fixed, 95% CI)0.88 [0.62, 1.25]

 16 Interval between births (in months)1783Mean Difference (IV, Fixed, 95% CI)1.90 [-2.03, 5.83]

 
Comparison 2. Sensitivity analysis: pre-pregnancy intervention versus routine care: including all women randomised and not lost to follow up (Lumley study, pregnancy outcomes)

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

 1 Became pregnant and had baby small-for-gestational age (< 10th percentile)11013Risk Ratio (M-H, Fixed, 95% CI)1.33 [0.85, 2.10]

 2 Became pregnant and had extremely preterm birth (less than 28 weeks)11034Risk Ratio (M-H, Fixed, 95% CI)9.25 [0.50, 171.31]

 3 Became pregnant and had preterm birth (less than 37 weeks)11034Risk Ratio (M-H, Fixed, 95% CI)1.45 [0.79, 2.67]

 4 Became pregnant and birthweight less than 2500 g11034Risk Ratio (M-H, Fixed, 95% CI)1.84 [0.97, 3.50]

 5 Became pregnant and baby had congenital anomaly11039Risk Ratio (M-H, Fixed, 95% CI)2.57 [0.50, 13.20]