A randomised controlled trial of flexibility in routine antenatal care

Authors


Correspondence: Dr D. Jewell, Division of Primary Health Care, University of Bristol, Canynge Hall, Whiteladies Road, Bristol BS8 2PR, UK.

Abstract

Objective To assess changes in satisfaction associated with a flexible approach to antenatal care schedules offered to women at low obstetric risk.

Design Randomised controlled trial.

Setting Eleven primary care centres providing midwifery care in Avon.

Participants Six hundred and nine women at low risk of obstetric complications presenting for antenatal care.

Methods A standard antenatal care schedule (‘traditional care’) was compared with a schedule based on a minimum number of visits and additional visits with timing agreed between women and midwives (‘flexible care’).

Main outcome measures Women's attitudes to pregnancy and motherhood using a subscale of the Maternal Adjustment and Maternal Attitudes scale, satisfaction with antenatal care, and perception of the speed of recognition of antenatal complications.

Results There was no difference between the two groups in terms of attitudes to pregnancy and motherhood (mean difference on Maternal Adjustment and Maternal Attitudes scale −0.64, 95% CI −1.39 to 0.11, P= 0.068) and no difference in the proportions of women reporting antenatal problems as soon as possible (traditional group 74.5%, flexible group 76.4%, difference −2%, 95% CI −12.1 to 8.2, P= 0.70). Women receiving traditional care reported higher levels of satisfaction for the care provided by community midwives (P < 0.01). Women receiving flexible care were more likely to report having a choice over the number and timing of their antenatal visits (P < 0.001), but were also more likely to report that they would like to have been seen more often (P < 0.01). There was no difference between the groups in rates of obstetric complications.

Conclusions An imposed reduction in antenatal visits has been reported to increase dissatisfaction in other studies. In this study, encouraging women to adopt a flexible approach to antenatal care resulted in a similar finding. Successful implementation of such approaches may depend on more careful selection of women who welcome such an approach, more encouragement to pregnant women to express their own needs and greater feelings of commitment on the part of the care providers.

INTRODUCTION

For some years there has been a trend in favour of reducing the number of routine antenatal attendances in low risk pregnancies. The value of such a high number of visits was first questioned in 1980 on the grounds of effectiveness1. The Expert Maternity Group, in its report Changing Childbirth2, expressed the same concern and recommended that the total number of antenatal visits for women with uncomplicated pregnancies should be reviewed in the light of the available evidence. While the assumption has been that, on the whole, women may get psychological benefit from frequent antenatal attendances, McDuffie et al.3 has suggested possible advantages to less care including reducing the time spent away from work or home and lower direct medical costs.

In the last few years there have been several studies evaluating packages of care aimed at reducing the number of antenatal attendances3–8. All of these studies have achieved reductions in the numbers of visits, but in some at the cost of an increase in anxiety over certain aspects of pregnancy or dissatisfaction with the quality of care. In two studies it was also found difficult to achieve the originally intended reduction in the number of visits4,7.

If a prescribed reduction in the number of attendances results in some women feeling they have not been properly cared for, then it is worth trying to establish if such an outcome can be avoided by introducing a reduction in a more flexible way, where women are encouraged to adapt the package of antenatal care to their own needs. This study is a randomised controlled trial designed to address this question among pregnant women at low risk of medical or obstetric complications. The main purpose of the study was to measure changes in maternal satisfaction associated with a more flexible approach to antenatal care.

METHODS

Eleven practices were recruited when general practitioners and midwives expressed confidence to experiment with changing patterns of antenatal care following an hour's presentation and discussion. Other approached practices declined to participate because they were unwilling to abandon the traditional pattern. One practice had already abandoned traditional pattern and was not adequately staffed to revert to it.

Pregnant women booking for antenatal care between January 1996 and February 1997 who were at low risk of obstetric complications were invited by midwives to participate in the trial. The definition of low risk is defined by the following exclusion criteria: stillbirth or neonatal death; preterm birth (< 37 weeks of gestation); a baby born with birthweight less than 2.5 kg; severe pregnancy induced hypertension (not otherwise defined); woman's mother having a history of severe pregnancy induced hypertension (nulliparous women only); severe medical condition in current pregnancy; addiction to controlled drugs; recurrent (three or more consecutive) miscarriages. Of the 11 practices, five had midwives attached to, and based at, the practice; five had midwives attached to, but working separately from, the practice; and one had midwifery support provided by a midwifery team working independently from the practice. Women were provided with written information about the study prior to their booking appointment. In Bristol it has been standard practice for many years that pregnant women at low obstetric risk receive almost all their antenatal care in community settings.

Women were randomly assigned to a traditional or flexible schedule of antenatal care. The schedules of antenatal attendances were defined as:

  • • Traditional schedule of antenatal visits: See monthly until 28 weeks, then every two weeks until 36 weeks, then every week until delivery.
  • • Flexible schedule of antenatal visits (nulliparous women): See at least every eight weeks from booking until 32 weeks, then see at least every two weeks from 33 weeks until delivery.
  • • Flexible schedule of antenatal visits (parous women): See at least every eight weeks from booking until 32 weeks, then see at least every three weeks from 33 weeks until delivery.

The traditional schedule was intended to define exactly when women were seen. The flexible schedule was intended to define a minimum number of visits, with additional visits determined by the participating women's own wishes. Adherence to the schedules was encouraged by attaching a label to the front of the standard patient-held maternity record with wording of the above definitions. As the intervals between visits were not fixed it was impossible to specify the content of each visit. This was determined by the health professionals providing care. Who provided the care in each case was determined by the practice in each centre. The schedules of visits had been agreed beforehand with the clinical directors of the divisions of obstetrics and gynaecology of the two NHS trusts responsible for maternity care in Bristol. No specific training was provided for the health professionals and their willingness to participate was taken to signify confidence with the study protocol. The study was approved by the research ethics committees for the three NHS trusts in Bristol.

Randomisation was performed during the antenatal booking interview, following written consent, by telephone to the Division of Primary Health Care, Bristol University, stratifying by parity (nulliparous or parous) and by stage of gestation at time of booking (≤ 20 weeks, or > 20 weeks). Randomisation involved blocks of 20 women within strata, generated by an individual not involved in patient recruitment.

Women's views on maternity care were assessed by postal questionnaires sent at three points: within one week of recruitment, at 36 weeks of gestation and 10 weeks after delivery. These points were selected primarily to ensure comparability with respect to stage of pregnancy and time postpartum, and was preferred to choosing fixed points in time from randomisation. Two reminders were sent at fortnightly intervals to nonresponders. Details of antenatal attendances, including the place and health professional providing care, were recorded on a form inserted in the maternity record. The booking visit was counted as the first visit. Visits made exclusively for blood tests or routine ultrasound scans were not counted. Obstetric outcome data were obtained from maternity records following delivery.

Questionnaires requested the following information for measurement: demographic and obstetric history at booking; attitudes to pregnancy and motherhood, measured by one subscale of the Maternal Adjustment and Maternal Attitudes questionnaire9; the Reading and Cox adjectival scale measuring attitudes to pregnancy and the fetus10; the Edinburgh Postnatal Depression Scale 11; and attitudes to the antenatal care received. All questionnaires were piloted before use.

Primary outcomes selected a priori were: women's adjustment to motherhood measured by the Maternal Adjustment and Maternal Attitudes questionnaire; satisfaction with antenatal care; and perception of the speed of recognition of antenatal complications.

The number of antenatal attendances is reported as a measure of process and not of outcome. The process was also assessed by a focus group study of the midwives involved in the conduct of the trial and has been reported elsewhere12.

The sample size of the trial was calculated to provide 80% power to detect, with a 5% two-sided significance level, a 15% increase in the proportion of women satisfied with their antenatal care (i.e. from 55% to 70%)13. The sample size required to detect such a change was 500 women, 250 in each arm. Assuming a loss of no more than 15% of recruited women, it was estimated that 600 women would need to be recruited into the study.

Statistical analysis

A strict intention-to-treat analysis was not possible with some women lost in the course of the study. All women were analysed according to the group to which they were assigned. The following tests were used: χ2 test for categorical variables; unpaired t test for continuous variables; and the Wilcoxon rank sum test where parametric tests were not suitable. A 5% level of significance was chosen for primary outcomes and 1% for all other outcomes. For primary outcomes 95% CI were calculated, while for secondary outcomes 99% CI were determined. Data were analysed using SPSS for Windows. For differences in proportions, confidence intervals were calculated using the package Confidence Interval Analysis.

RESULTS

Details of the sample are shown in Fig. 1. A total of 1242 women registered with the participating practices booked for maternity care during the recruitment period. Four hundred and fifty-five women were not invited to participate: 146 because their obstetric or medical history excluded them and 309 because either they did not receive the information to enable them to take part, or the midwives forgot or were too busy to recruit them. Of the 787 women eligible and invited to join the study, 609 (77.3%) agreed to participate and were recruited. Subsequently, 65 were lost from the study: 28 miscarried; 13 moved away; seven had multiple pregnancies: six were identified as having been incorrectly recruited: four left voluntarily; and seven women's pregnancies ended in termination, stillbirth or neonatal death. Two other women who experienced a neonatal death continued, and returned their post delivery questionnaire. Of the 58 women whose patient-held maternity records were not available, the hospital maternity records were accessed to obtain outcome data on 55, leaving three women whose obstetric outcome data were unavailable. Response rates to the postal questionnaires at booking, 36 weeks of gestation, and 10 weeks post delivery were 95%, 90% and 88%, respectively. Demographic details on the 609 randomised are shown in Table 1, with data for comparison derived from the total population booking at one of the NHS trusts. The two randomised groups are similar to each other, and apart from a higher proportion of nulliparous women, they were also highly representative of the booking population (Table 1).

Figure 1.

Flow chart of women's progress in the study.

Table 1.  Demographic characteristics of sample. Values are given as %, unless otherwise indicated. NA = not available.
 Traditional care (n= 300)Flexible care (n= 309)Booking population (n= 7033)
Age (mean)28.028.228.3
Nulliparous48.451.641.2
Employed62.963.2NA
Living with partner85.288.388.4
Partner employed78.281.9NA
Smoking in pregnancy18.319.7NA

Pattern of antenatal attendances

Table 2 shows the pattern of attendances by the two groups. Flexible care resulted in fewer visits than traditional care; the difference was small but statistically significant (difference 1.5, 99% CI 0.7 to 2.3, P < 0.001), essentially through a reduction in the visits made to the community based midwives. This difference in overall attendance between the groups occurred in the period 21–32 weeks (mean 4.1 for the traditional group and 3.2 for the flexible group, P < 0.001). In addition, the longest period without an antenatal check was slightly longer in the flexible group than for those in the traditional group (difference 1.1 weeks, 99% CI 0.7 to 1.5, P < 0.001). There were no differences in the number of attendances made to general practitioners or hospital antenatal clinics. Although traditional care resulted in more visits, it did not lead to an increase in the number of different health professionals providing antenatal care to an individual woman. Instead it led to an increased number of visits to the professional seen most frequently (Table 2).

Table 2.  Antenatal attendances. Value are given as mean (SD) or mean [99% CI], unless otherwise indicated.
 Traditional care (n= 250)Flexible care (n= 236)Mean differenceP
  1. Comparisons by unpaired t test.

Total no. of checks13.1 (3.3)11.6 (3.5)1.5 [0.7 to 2.3]< 0.001
Maximum no. of weeks without a check4.5 (1.5)5.6 (1.9)−1.1 [−1.5 to −0.7]< 0.001
Reported continuity of care    
  No. of different midwives seen2.8 (1.5)2.8 (1.7)−0.020 [−0.41 to 0.36]0.85
  No. of different doctors seen1.3 (0.9)1.4 (1.1)−0.1 [−0.36 to 0.12]0.20
  No. of checks with the professional seen most frequently7.6 (4.9)6.3 (3.5)1.3 [0.15 to 2.45]0.004

There were no differences between the two groups in the numbers of day admissions, ultrasound scans, inpatient admissions and total nights in hospital prior to admission for delivery (data not shown).

Primary outcomes

There were no differences between groups in terms of satisfaction expressed for care provided by general practitioners. For antenatal care provided by community midwives or in the hospital, higher satisfaction was expressed by the women in the traditional group. For care provided by the hospital, there is a difference for the dichotomised data, but not when significance testing is applied to the original 5-point scale (Table 3).

Table 3.  Primary outcomes. Values are given as n/ntotal (%), % [95% CI] or mean {95% CI}, unless otherwise indicated. MAMA = maternal adjustment and maternal attitudes.
 Traditional careFlexible careDifferenceP
  1. *Figures are those reporting “very satisfied” on 5 point scale. Significance testing by Wilcoxon rank sum test using all data.

  2. Nupmbers reporting problems identified ‘as soon as possible’. Significance testing by x2 test.

  3. Attitudes to pregnancy and motherhood subscale (range 12–48). Significance testing by unpaired t test.

Overall satisfaction    
  With care provided by midwives*174/242 (72)135/224 (60)11 .6 [3.1 to 20.2]0.01
  With care provided by family doctors*109/213 (51)90/196 (42)5.3 [−4.4 to 14.9]0.76
  With care provided by hospital*50/88 (54)36/86 (42)15 [2.7 to 29.6]0.18
Antenatal problems    
  No. reporting problems102/137 (74)107/140 (76)−2 [.12.1 to 8.2]0.70
MAMA    
  Attitudes to pregnancy and motherhood subscale(n= 239) 19.9 (4.1)(n= 215) 20.5 (3.9)−0.64 {.1.39 to 0.11}0.068

There were no differences between the two groups on the other two primary outcomes: the perception of how quickly antenatal problems had been identified, and on the adaptation to motherhood.

The number of women not completing the trial was not trivial (Fig. 1). Since almost all withdrawals occurred for reasons unrelated to the intervention, it was felt unlikely to affect the overall result. However, we conducted sensitivity analyses for Maternal Adjustment and Maternal Attitudes scores, replacing missing values at the mean, one standard deviation above and one standard deviation below for that group. For recognition of antenatal problems, we replaced all missing values either with problems recognised as soon as possible or not as soon as possible14. This was only carried out for missing data among women who were genuinely eligible for the trial, (i.e. women who had moved, withdrawn, had stillbirths or neonatal deaths). Women who were valid post-randomisation withdrawals (e.g. incorrectly recruited, twins, miscarriages or terminations) were omitted from the sensitivity analyses. The total number of women for the sensitivity analyses were therefore 288 in the traditional group and 278 in the flexible group. For the recognition of antenatal problems the results were the same. The results for the maternal adjustment and maternal attitudes scores were also very little affected, although there were small but significant differences for scores at the mean or one SD above the mean, with those in the flexible group showing higher scores. However, the difference between the group means remained < 1 in each case.

Secondary outcomes

Women receiving flexible care were significantly more likely to perceive that they had a choice over the number and timing of their visits, at every stage of their antenatal care compared with women receiving traditional care (P < 0.001 before 25 weeks, at 25 to 34 weeks, and after 34 weeks). More women in the traditional group felt able to ask for additional visits, but this was not significant at the 1% level (traditional 75.1%, flexible 66.4%, difference 8.7; 99% CI −2.1 to 19.6, P= 0.039). Similarly, although the majority of women in both groups (traditional 73.9%; flexible 68.8%) stated that the number of visits they had was ‘just the right number’, women receiving flexible care were more likely to state that they had too few visits (traditional 16.5%, flexible 28.0%), and less likely to state that they had too many visits (traditional 9.6%, flexible 5.2%, P= 0.006).

Women were asked at 36 weeks which type of care they would recommend to a friend. Of the 218 women receiving traditional care, 49% said they would recommend traditional care, and 51% flexible care. Of the 231 women receiving flexible care 51% said they would recommend traditional care and 49% flexible care.

Table 4 shows antenatal complications and obstetric outcomes. There were no significant differences between the groups in the rates of detection, rates of referral to hospital or treatment for hypertensive disorders of pregnancy; investigation for or diagnosis of small for gestational age; having a glucose tolerance test; induction of labour; hours in hospital before delivery; mode of delivery; gestation at delivery; infant birthweight; admission to the neonatal unit; and Apgar scores.

Table 4.  Clinical outcomes. Values are given as %, mean (SD), % [99% CI] or mean {99% CI}, unless otherwise indicated.
 Traditional care (n= 279)Flexible care (n= 265)DifferenceP
  1. *Unpaired t test.

  2. *cχ2 test.

Hypertensive disorders of pregnancy    
  Hypertension identified8.610.9−2.3[−8.9 to 4.2]0.36
  Referred to hospital for assessment7.57.9−0.4[−6.3 to 5.5]0.86
  Treated with antihypertensives1.11.5−0.4[−2.9 to 2.1]0.88
Small for gestational age    
  Suspected3.98.3−4.4[−9.7 to 0.9]0.033
  Diagnosed prior to labour2.23.8−1.6[−5.4 to 2.2]0.26
Glucose tolerance test performed(n= 275) 10.2(n= 260) 11.5−1.4[−8.3 to 5.6]0.61
Labour    
  Induction of labour (any reason)21.120.01.1[−7.8 to 10.1]0.74
  Spontaneous vaginal delivery73.876.6−2.8[−12.3 to 6.8]0.45
Neonatal outcomes    
  Gestation at delivery (days)*278 (15)278 (16)0.51{−4.1 to 3.0}0.71
  Birthweight (kg)*3.42 (0.63)3.44 (0.56)−0.016{−0.15 to 0.12}0.74
  Admitted to neonatal unit(n= 277) 6.1(n= 264) 5.3−0.8{–4.3 to 6.0}0.68
  Apgar score at 5 minutes*9.4 (1.1)9.4 (0.9)−0.07{−0.3 to 0.1}0.41

Psychosocial variables

At 36 weeks of pregnancy there were no statistically significant differences between the two groups with respect to the level of confidence reported by women about the forthcoming labour, birth, infant feeding or general baby care. Similarly, there was no difference in positive or negative attitudes expressed towards the fetus. The two groups did not differ significantly in scores obtained on the Edinburgh Postnatal Depression Scale, either in terms of mean scores (traditional 4.9, flexible 5.2; difference −0.31; 99% CI −1.31 to 0.68; P= 0.69) or in the proportion of women above the standard cut off score for depression of 12 (traditional 4.0%, flexible 5.9%; difference −1.9; 99% CI −7.1 to 3.3; P= 0.35). There were no differences in feelings of tiredness, or the degree of confidence or worry expressed over coping with the new baby.

Women in the two groups felt similarly about the amount of information received and in the understanding of information given to them during their visits. Women receiving flexible care were as likely as women receiving traditional care to state that they saw staff who knew them at visits. The two groups of women felt equally able to ‘discuss things fully’ with their midwife and general practitioner. There were no significant differences in the proportions of women in the two groups who expressed a desire to ‘know more about’ labour and related topics, or who had attended antenatal classes.

DISCUSSION

In this study, encouraging a more flexible approach to antenatal care conferred no significant advantage or disadvantage in terms of psychosocial or obstetric outcomes. The main differences concerned the perceptions of the care women received. Women having flexible care were more likely to say that they would have liked to have been seen more often and were more dissatisfied with the antenatal care provided by midwives. Despite encouraging a more flexible approach, and their own sense of being more able to exert control over the timing of their attendances, women in the flexible group did not seem to be able to adapt the package of care to their own needs. In particular, they were less likely than women in the traditional group to feel able to contact the midwife to ask for an extra check-up for reassurance.

The women studied were at low risk of obstetric complications and, because of the centres in which we recruited, were not living in areas of socioeconomic deprivation. The majority were supported by a partner, with either the partner, the woman or both employed. Such women might be expected to find it easier to express their needs to professionals than those from more deprived areas. However, women from higher socioeconomic groups are generally reported to be more consistent users of antenatal care15,16. Women in the flexible group may have been confused by the conflict between the traditional message of compliance and the one that accompanied their care in this study.

The conclusions from this study are broadly consistent with the literature published to date. Of the five published papers of randomised controlled trials where an experimental group had a reduced schedule of visits compared with a standard package, none have shown any differences in maternal or neonatal outcomes3,5–8. Four of these studies gave information on satisfaction. In two studies, the women randomised to a reduced schedule reported less satisfaction with antenatal care5,7, although one of these was associated with improved satisfaction with continuity of care5, and more worries about their babies7. In the other two studies women favoured fewer visits. Women having fewer visits were either more satisfied8, or were more likely to view the number of visits as ‘just right’3. The study conducted in Zimbabwe differed because the unit of randomisation was the antenatal clinics and not the pregnant women, although this was not accounted for in the analysis6.

This study, therefore, shares with Sikorski et al.7 and Binstock et al.5 the finding that a reduction in the number of visits can result in women feeling that they are not being properly looked after.

This study has not succeeded in producing a more effective and acceptable model for care centred around women's individual needs. The possible reasons for this include: a failure at the outset to make sufficiently clear what was being offered to the women in the flexible group; a failure on the part of those providing care to reinforce the message during pregnancy, or to help the pregnant women to consider their needs at scheduled visits; or an unwillingness on the part of the women to consider or express their needs. Providing an overall structure, and asking women to respond flexibly to their own needs within it, may be a conflict that the women found difficult to resolve. As we found when planning this study, providing flexible care that is truly womancentred while reassuring professionals that new models of care remain safe, is difficult. We gained additional insight with the focus group study. Midwives supported the principle both of reducing overall contact and of flexible care. At the same time they found it difficult to implement the changes, expressing anxiety both about women's psychological needs and about what felt like a long interval of eight weeks without being seen. This is reflected in the small differences in the number of visits between the two groups despite statistical significance. Asking professionals to provide less care may create a tension between one model that appears to be scientifically appropriate and another that is familiar and trusted16. It is possible that the professionals consciously or unconsciously transmit such tension to the women who respond accordingly. This would explain the finding, consistent in some of the related studies, that a reduction in visits can be associated with some adverse psychological outcomes, whatever the original pattern of care.

Such a conclusion poses a problem for health policy makers and planners. For women at low risk of obstetric complications it seems to be possible to make small reductions in the amount of routine care offered. There is no apparent increase in obstetric or neonatal risk, but the saving is balanced by women's feelings that they have not been adequately cared for. Relying on pregnant women themselves to respond to their own needs by asking for additional visits when required may, on current evidence, be asking too much of them.

Acknowledgements

This study was funded by a grant from the South West Research and Development Directorate. We should also like to acknowledge the help of the midwives and doctors who took part in the project, and all the pregnant women who agreed to take part and were so conscientious in completing the questionnaires. Bristol is the lead centre of the MRC Health Services Research Collaboration.

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