Antenatal day care units versus hospital admission for women with complicated pregnancy

Abstract

Background

Antenatal day care units have been widely used as an alternative to inpatient care for women with pregnancy complications including mild and moderate hypertension, and preterm prelabour rupture of the membranes.

Objectives

The objective of this review is to compare day care units with routine care or hospital admission for women with pregnancy complications in terms of maternal and perinatal outcomes, length of hospital stay, acceptability, and costs to women and health services providers.

Search methods

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (February 2009).

Selection criteria

Randomised controlled trials comparing day care with inpatient or routine care for women with complicated pregnancy.

Data collection and analysis

Two review authors independently carried out data extraction and assessed studies for risk of bias.

Main results

Three trials with a total of 504 women were included. For most outcomes it was not possible to pool results from trials in meta‐analyses as outcomes were measured in different ways.

Compared with women in the ward/routine care group, women attending day care units were less likely to be admitted to hospital overnight (risk ratio 0.46, 95% confidence interval 0.34 to 0.62). The average length of antenatal admission was shorter for women attending for day care, although outpatient attendances were increased for this group. There was evidence from one study that women attending for day care were significantly less likely to undergo induction of labour, but mode of birth was similar for women in both groups. For other outcomes there were no significant differences between groups.The evidence regarding the costs of different types of care was mixed; while the length of antenatal hospital stays were reduced, this did not necessarily translate into reduced health service costs.

While most women tended to be satisfied with whatever care they received, women preferred day care compared with hospital admission.

Authors' conclusions

Small studies suggest that there are no major differences in clinical outcomes for mothers or babies between antenatal day units or hospital admission, but women may prefer day care.

Plain language summary

Antenatal day care units versus hospital admission for women with pregnancy complications

Many women experience complications during pregnancy such as high blood pressure, threatened early labour or abnormal and heavy bleeding (haemorrhage). Admission to hospital may be necessary but can be disruptive to the mother and her family. Often tests and monitoring are needed so that the condition of the mother and baby can be assessed and treatment can be provided. Sometimes this care can be given in day care units to avoid the need for an overnight stay in hospital. The review compares day care units with hospital admission or routine care. Three trials, involving 504 pregnant women with high blood pressure or preterm prelabour rupture of the membranes, were included in the review. The findings were that women receiving day care had to make more visits to hospital as outpatients but were less likely to stay in hospital overnight. Care in day units did not seem to affect other outcomes for mothers and babies or increase or reduce interventions in labour; although women in one trial were less likely to have their labours induced if they received day care. Two studies provided evidence that women preferred day care to hospital admission and no women expressed a preference for more inpatient care; most women in both groups felt they had received good care and were satisfied with it.

The aim of antenatal care is to reduce adverse outcomes for mothers and babies but these are relatively infrequent and could not be investigated in this review. A proportion of women attending for day care require subsequent inpatient care, and a range of non‐medical considerations such as travelling distance to emergency facilities, social factors and women's emotional wellbeing may lead to admission to hospital. All studies included in the review were carried out as part of evaluations of new services.

Background

This review updates and replaces an earlier Cochrane Review on antenatal day care units (Kroner 2001).

Introduction

Many women experience pregnancy complications that could potentially lead to hospital admission. Dunlop et al have suggested three main reasons why women are admitted to hospital during pregnancy (Dunlop 2003). First, a woman may need treatment that it would not be feasible to provide outside hospital; second, she may be at risk of her condition worsening over a short period of time, and need emergency facilities close at hand; and third, tests and monitoring may be needed so that the condition of the mother and baby can be assessed and decisions about treatment made. In the latter case, it may be more convenient to women, and more efficient for health service providers, if women do not stay in hospital overnight, but instead attend an antenatal day care unit for initial tests and monitoring. Subsequently, women may be admitted for inpatient care, or discharged home with arrangements for any necessary follow up.

Admission to hospital during pregnancy

Several large observational surveys have provided information on the numbers of women admitted to hospital during pregnancy and on trends in admission rates. They have also described those women most at risk of, and those complications most likely to result in, hospitalisation (Adelson 1999; Bacak 2005; Bennett 1998; Franks 1992; Liu 2007; Scott 1997).

Population‐based studies in the United States (US) have revealed a considerable decline in antenatal hospital admissions during the 1980s and 1990s (Bacak 2005; Bennett 1998). Between 1991 to 1992 and 1999 to 2000 the total rate of (non‐delivery) admissions in the US declined from 17.6 to 12.8 per 100 deliveries (Bacak 2005). Similar declines in the rate of admissions during pregnancy have been described elsewhere (Liu 2007). This decline (which generally mirrors declining overall rates of hospitalisation) has been ascribed to different management rather than reflecting any reduction in the incidence and prevalence of pregnancy complications (Bacak 2005; Bennett 1998). Over the same period, the average length of hospital stay has also declined; and again this is thought to relate to changed management as well as improved therapies, rather than to reduced morbidity.

The complications leading to hospital admission during pregnancy include the onset of preterm labour or threatened preterm labour (accounting for approximately a quarter of admissions); hypertensive disorders including pre‐eclampsia; hyperemesis (severe vomiting); antenatal haemorrhage; genito‐urinary complications and diabetes (Adelson 1999; Bacak 2005; Franks 1992; Liu 2007; Scott 1997; Zwart 2008). Evidence from observational studies shows that risk of hospitalisation during pregnancy is greater for younger women and those without private health insurance, and that it varies for different ethnic groups, and in different geographical areas and healthcare settings (Adelson 1999; Bacak 2005; Liu 2007; Scott 1997).

Antenatal day care units

Admission to hospital during pregnancy is likely to disrupt the lives of women and their families, and may be associated with costs to women (who may lose time at work or need to arrange for the care of other children) and to health service providers. Women may prefer to be cared for in less formal settings and to remain at home overnight, and hospital admission may exacerbate anxiety. On the other hand, women may be reassured by being cared for in hospital, and care in day units may not necessarily lead to cost savings for women or healthcare providers.

During the1980s an alternative to inpatient care for women with pregnancy complications was introduced: the antenatal day assessment unit. In different contexts these facilities have been given different names (e.g. antenatal day care units or obstetric day wards) and their functions vary. Women attending the units frequently undergo the same tests and monitoring as they would receive as inpatients, and treatment may be initiated. Where results of investigations indicate that no immediate inpatient treatment is necessary, women may be discharged home, possibly with arrangements to attend the unit for further monitoring. These facilities were set up with a view to reducing overnight hospital stays, although it was not clear that transferring care to other settings would realise cost savings. Early evaluations suggested that the units were acceptable to women and care providers, and offered the potential for cost reductions compared with inpatient care (Dunlop 2003; Lewis 1993; Rosenberg 1990; Twaddle 1992; Twaddle 1995; Walker 1993).

The organisation of different day units varies; some are staffed by midwives (with medical support) and offer informal facilities with home‐like furnishings and facilities for families to accompany women; other facilities resemble more traditional hospital wards which close overnight. Women attending units may stay for several hours during which time tests and monitoring are carried out (including assessment of both mother and baby). Women frequently receive their test results, and subsequent management is arranged, on the same day (Dunlop 2003; Lewis 1993; Rosenberg 1990).

While hospital admission for pregnancy complications such as hypertension has declined over the past 20 years a significant proportion of women continue to require inpatient care (Duley 2006; Rosenberg 1990); some women have serious and deteriorating conditions and require immediate admission. A proportion of those attending for day care will require subsequent inpatient care, and a range of non‐obstetric considerations (travelling distance from emergency facilities, social factors, and women's emotional wellbeing) may prompt formal admission to hospital. Many units were set up before any formal evaluations by randomised controlled trials had been carried out.

Objectives

The objective of the review is to examine whether antenatal day care units improve outcomes for women with complicated pregnancy compared with hospital admission or routine care.

Compared with hospitalisation or routine care,

• does antenatal day care improve clinical outcome for mothers and babies?

• does antenatal day care improve satisfaction and the psychological wellbeing of women?

• is antenatal day care more cost effective?

Methods

Criteria for considering studies for this review

Types of studies

Randomised or quasi‐randomised allocation to an intervention (day care) or a control group (hospital admission or routine management of pregnancy complications).

Types of participants

Women with any pregnancy complication that would have ordinarily led to hospitalisation or where hospitalisation was an option as part of routine care.

Types of interventions

Definition of antenatal day care: admission and discharge home with no overnight stay. The control group receives inpatient care or routine management (which includes the option of inpatient care).

Types of outcome measures

Primary outcomes

Maternal

• Admission to hospital

• Length of antenatal stay

• Number of antenatal day care visits

• Serious maternal morbidity

• Maternal mortality

Perinatal

• Apgar score at five minutes

• Gestational age at delivery before 37 weeks

• Birthweight less than 2500 g

• Admission to special/intensive care units

• Length of postnatal stay

• Perinatal mortality

Secondary outcomes

Maternal

• Induction or augmentation of labour

• Mode of delivery

• Length of postnatal stay

Psychosocial outcomes

• Satisfaction with care

• Anxiety

• Depression

Economic outcomes

• The incremental public health service cost per episode

• The incremental personal cost

Search methods for identification of studies

We contacted the Trials Search Co‐ordinator to search the Cochrane Pregnancy and Childbirth Group’s Trials Register (February 2009). 

The Cochrane Pregnancy and Childbirth Group’s Trials Register is maintained by the Trials Search Co‐ordinator and contains trials identified from:

1. quarterly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);

2. weekly searches of MEDLINE;

3. handsearches of 30 journals and the proceedings of major conferences;

4. weekly current awareness alerts for a further 44 journals plus monthly BioMed Central email alerts.

Details of the search strategies for CENTRAL and MEDLINE, the list of handsearched journals and conference proceedings, and the list of journals reviewed via the current awareness service can be found in the ‘Specialized Register’ section within the editorial information about the Cochrane Pregnancy and Childbirth Group.

Trials identified through the searching activities described above are each assigned to a review topic (or topics). The Trials Search Co‐ordinator searches the register for each review using the topic list rather than keywords. 

We did not apply any language restrictions.

SeeAppendix 1 for details of the searching carried out for the previous version of the review.

Data collection and analysis

Selection of studies

Two review authors (P Middleton (PM), T Dowswell (TD)) independently assessed the eligibility for inclusion for all the studies we identified as a result of the search strategy. We resolved any disagreement through discussion.

Data extraction and management

We designed a form to extract data. For eligible studies, two review authors (PM, TD) extracted data using the agreed form. We resolved discrepancies through discussion. We entered data into Review Manager software (RevMan 2008) and checked them for accuracy.

Assessment of risk of bias in included studies

Two review authors independently assessed risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2008). We resolved any disagreement by discussion or by involving a third assessor.

(1) Sequence generation (checking for possible selection bias)

We have described for each included study the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.

We assessed the method as:

• adequate (any truly random process, e.g. random number table; computer random number generator);

• inadequate (any non random process, e.g. odd or even date of birth; hospital or clinic record number);

• unclear.   

 (2) Allocation concealment (checking for possible selection bias)

We have described for each included study the methods used to conceal the allocation sequence to assess whether intervention allocation could have been foreseen in advance of, or during recruitment, or changed after assignment.

We assessed methods as:

• adequate (e.g. telephone or central randomisation; consecutively numbered sealed opaque envelopes);

• inadequate (open random allocation; unsealed or non‐opaque envelopes, alternation; date of birth);

• unclear.   

(3) Blinding (checking for possible performance bias)

We have described for each included study all the methods used, if any, to blind study personnel from knowledge of which intervention a participant received. We have provided information on whether the intended blinding was effective. With an intervention such as allocation to a day care unit rather than hospital admission, it is generally not feasible to blind women and clinical staff to treatment allocation, but it may be possible to blind outcome assessors.

We assessed the methods as:

• adequate, inadequate or unclear for outcome assessors.

(4) Incomplete outcome data (checking for possible attrition bias through withdrawals, dropouts, protocol deviations)

We have described for each included study and for each outcome, or class of outcomes, the completeness of data including attrition and exclusions from the analysis. We state whether attrition and exclusions were reported, the numbers included in the analysis at each stage (compared with the total randomised participants), reasons for attrition or exclusion where reported, and whether missing data were balanced across groups or were related to outcomes. 

(5) Selective reporting bias

We have described for each included study how the possibility of selective outcome reporting bias was examined by us and what we found.

We assessed the methods as:

• adequate (where it is clear that all of the study’s pre‐specified outcomes and all expected outcomes of interest to the review have been reported);

• inadequate (where not all the study’s pre‐specified outcomes have been reported; one or more reported primary outcomes were not pre‐specified; outcomes of interest were reported incompletely and so could not be used; study failed to include results of a key outcome that would have been expected to have been reported);

• unclear.

(6) Other sources of bias

We have described for each included study any important concerns we have about other possible sources of bias such as baseline imbalance across groups.

We assessed whether each study was free of other problems that could put it at risk of bias:

• yes;

• no;

• unclear.

(7) Overall risk of bias

We have made explicit judgements about whether studies are at high risk of bias, according to the criteria given in the Handbook (Higgins 2008). With reference to (1) to (6) above, we have assessed the likely magnitude and direction of the bias and whether we consider it is likely to impact on the findings. 

Measures of treatment effect

Dichotomous data

For dichotomous data, we have presented results as summary risk ratio with 95% confidence intervals. 

Continuous data

For continuous data, we have used the mean difference where outcomes in trials were measured in the similar ways. In updates of the review we will use the standardised mean difference to combine trials that measure the same outcome, but use different methods.  

Unit of analysis issues

Cluster‐randomised trials

We did not identify any cluster‐randomised trials; in updates of the review, if such trials are identified, we will include them in the analyses along with individually‐randomised trials. The standard error will be adjusted using the methods described in Higgins 2008. We will use an estimate of the intracluster correlation co‐efficient (ICC) derived from the trial (if possible), or from another source. If ICCs from other sources are used, this will be reported and sensitivity analyses conducted to investigate the effect of variation in the ICC (Gates 2005). If we identify both cluster‐randomised trials and individually‐randomised trials, we plan to synthesise the relevant information. We will consider it reasonable to combine the results from both if there is little heterogeneity between the study designs and the interaction between the effect of intervention and the choice of randomisation unit is considered to be unlikely.

Crossover trials

Crossover designs are not an appropriate study design for this topic area and trials using this design have not been included.

Dealing with missing data

For included studies, levels of attrition have been noted.

For all outcomes analyses have been carried out, as far as possible, on an intention‐to‐treat basis, i.e. we attempted to include all participants randomised to each group in the analyses. The denominator for each outcome in each trial was the number randomised minus any participants whose outcomes were known to be missing.

Assessment of heterogeneity

We examined the forest plots of each analysis to look for heterogeneity amongst the trials. We used the I² statistic to quantify the level of heterogeneity. For most of the outcomes in the review results were from individual trials or results from only two trials were pooled and levels of heterogeneity were generally low. 

Assessment of reporting biases

Where we suspected reporting bias (see 'Selective reporting bias' above), we have noted this.

Data synthesis

We carried out statistical analysis using RevMan 2008. We used fixed‐effect meta‐analysis for combining data where trials examined similar interventions, and the trials’ populations and methods were judged sufficiently similar.

Subgroup analysis and investigation of heterogeneity

By parity (nulli‐ versus multiparous women)

We planned to carry out subgroup analysis by parity for primary outcomes. However, data were not available to conduct these analyses. In updates of the review, if such data become available for fixed‐effect meta‐analyses, we will conduct planned subgroup analyses classifying whole trials by interaction tests as described by Deeks 2001. For random‐effects meta‐analyses, we will assess differences between subgroups by inspection of the subgroups’ confidence intervals; non‐overlapping confidence intervals indicate a statistically significant difference in treatment effect between the subgroups.

Sensitivity analysis

We planned to carry out sensitivity analysis whereby in pooled analyses we would remove those studies with poor allocation concealment to see whether this would have any impact on the size or direction of the treatment effect. In the event, one study provided little information on methods (Hooker 1986) while the remaining two included studies had adequate allocation concealment. However, the study with poor allocation concealment contributed only very limited data and we did not think further analyses would be particularly illuminating.

Results

Description of studies

Using the search strategy we identified four trials for possible inclusion. We excluded one study as the intervention group included women attending antenatal clinics as well as day care units, and separate results were not available for those women attending the day care unit (Leung 1998).

We included three studies with a total of 504 women. Two of the studies were carried out in the United Kingdom in the 1980s (Hooker 1986; Tuffnell 1992) and one study in Australia between 1998 and 2001 (Turnbull 2004).

In the study by Hooker 1986, 55 women with mild to moderate hypertension were randomised to attend a day care unit versus hospital admission. Women attending the day unit had two‐hourly blood pressure checks, but it was not clear how long they remained on the unit, and there was no information on how those women admitted as inpatients were managed.

The study by Tuffnell 1992 also focused on women with hypertension. In this trial, women in the intervention group attended a four‐bed day care unit for blood pressure measurements (five readings), urine analysis and a range of other tests. Women were reviewed and then either discharged home with arrangements for any necessary follow up, or admitted to hospital. The comparison group received routine care which varied at the discretion of the referring clinician, and did not necessarily involve inpatient care.

The third and largest of the three studies (Turnbull 2004), focused on three pregnancy complications frequently leading to hospital admission: hypertension with proteinuria, hypertension without proteinuria, and preterm premature rupture of the membranes. In this study, the day care unit was compared with admission to a hospital ward. The day care unit was described as "deinstitutionalised" with informal seating and dining areas where women could be accompanied by other family members.

Further details of the inclusion criteria, interventions and participants are set out in the Characteristics of included studies tables.

Risk of bias in included studies

One study provided little information on study design (Hooker 1986). In this study it was not clear how the randomisation sequence was generated, whether there was any attempt to conceal group allocation, or the number of women included in the analyses for different outcomes. Results from this study may be at high risk of bias and should be interpreted with caution. The remaining two studies had adequate allocation concealment and low rates of attrition (at least for those outcomes where data were collected from case notes) (Tuffnell 1992; Turnbull 2004). It was not possible to blind women or clinical staff to group allocation in any of these studies, and this may be a source of bias. It is possible that where an intervention represents a new and innovative form of care (that is being evaluated in a trial) clinical staff serving women in the intervention arm may be particularly motivated to provide a high standard of care.

Effects of interventions

This review aimed to answer questions about length of hospital stay, clinical outcomes, satisfaction with care and costs in day care units compared with routine management or hospital admission.

Primary outcomes

Antenatal length of stay, admissions and visits (Analysis 1.1 to Analysis 1.5)

All three trials provided some data on antenatal admissions; however, outcomes were measured in a number of ways and we were unable to pool data from trials for most outcomes.

In the study by Tuffnell 1992, there was a significant reduction in length of antenatal hospital stays for the women in the day care group compared with women receiving routine care (mean difference (MD) of 4.00 fewer days, 95% confidence interval (CI) ‐5.96 to ‐2.04) (Analysis 1.1). In the later study by Turnbull et al (Turnbull 2004), the average length of stay was also considerably shorter for women attending the day care unit. The overall length of hospital stay was reported to be less than a day in the day care group (median stay 17 hours, interquartile range (IQR) 5 to 9 hours). This compared with an average stay of more than two days for those in the ward group (median length of antenatal stay 57 hours, IQR 35 to 123 hours). The difference between groups was reported to be statistically significant (P < 0.001).

1.1. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 1 Length of antenatal stay.

Two studies (with 109 women) provided information on the number of women admitted to hospital for at least one night. As might be expected, fewer women in the day care group were admitted to hospital overnight for antenatal complications (risk ratio (RR) 0.46, 95% CI 0.34 to 0.62) (Analysis 1.2). In contrast, compared with women receiving routine care, women in the day care group made more outpatient visits. In the trial by Tuffnell 1992, women made more separate visits to hospital (MD 1.5 more visits, 95% CI 0.54 to 2.46). Similarly, in the Turnbull 2004 study, compared with women admitted to the ward, those in the day care group were reported to have, on average, more separate care "episodes" in the antenatal period (total episodes included hospital admissions, day care unit visits and visits to the emergency department) (MD 0.41, 95% CI 0.05 to 0.77) (Analysis 1.4). Hooker 1986 reported that there was no difference in the number of women requiring three successive days' care either in hospital or on the day unit (Analysis 1.5).

1.2. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 2 Women admitted antenatally.

1.4. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 4 Total antenatal care episodes.

1.5. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 5 Antenatal hospital stay for less than three days (as either inpatient or staying on the day unit).

Maternal morbidity and other maternal outcomes

There was no maternal mortality in the two studies reporting this outcome (Analysis 1.6). Maternal morbidity (the development of further complications) in the antenatal period did not differ significantly between the day care and the inpatient groups (RR 1.30, 95% CI 0.57 to 2.95).

1.6. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 6 Maternal mortality.

(In an unpublished paper by Hooker 1986, it was reported that one woman allocated to the day care group was later admitted to hospital; she then discharged herself, and was later admitted to another hospital with fulminating pre‐eclampsia and a placental abruption. We have included this case in the analysis for maternal complications according to randomisation group. It was not clear what the eventual outcomes were for the mother or for the baby.)

Neonatal outcomes

No perinatal mortality was recorded in any of the trials (although the outcome for one baby whose mother had serious morbidity, but who withdrew from the study, was not reported in the Hooker 1986 study). There were no significant differences between groups for Apgar scores at five minutes (Analysis 1.10; Analysis 1.11), gestational age at delivery (Analysis 1.12), admission to neonatal special care (Analysis 1.13) or birthweight (Analysis 1.14).

1.10. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 10 Apgar score at five minutes.

1.11. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 11 Apgar score seven or less at five minutes.

1.12. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 12 Gestational age at delivery (days).

1.13. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 13 Admission to intensive care unit/special care unit.

1.14. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 14 Birthweight (grams).

Secondary outcomes

There was little information on interventions in labour. Turnbull 2004 reported that there were no significant differences between groups for mode of birth or interventions in labour. Data from the Tuffnell 1992 study partly supported these findings, with similar numbers of women in the day care and comparison group having instrumental and caesarean deliveries (Analysis 1.19; Analysis 1.20; Analysis 1.21). However, in this study, fewer women in the day care group had their labours induced compared with women receiving routine care (RR 0.43, 95% CI 0.22 to 0.83). (Overall, the numbers of women undergoing induction or augmentation, or both, were similar for both study groups in the Turnbull 2004 study; separate figures for inductions were not reported (Analysis 1.18).)

1.19. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 19 Normal vaginal birth.

1.20. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 20 Forceps birth.

1.21. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 21 Caesarean section.

1.18. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 18 Induction/augmentation of labour.

The length of postnatal stay for women randomised to day care versus routine or hospital care was similar (Analysis 1.15).

1.15. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 15 Postnatal stay.

In Turnbull 2004 the overall length of stay (including antenatal, intrapartum and postnatal hospital care) for mothers and babies was significantly shorter in the day care group than in the inpatient group (MD 1.31 fewer days, 95% CI ‐2.36 to ‐0.26) but this did not translate into any overall reduction in health service costs for women in this group compared with the ward group (Analysis 1.26; Analysis 1.27). In the study by Tuffnell 1992, unpublished data revealed that compared with hospital admission, day care was potentially cheaper for both health service providers and for women. However, the authors noted that not all savings are realisable; many costs remain fixed, unused resources may not be redeployed, and the existence of an alternative form of care (day care unit) may exert new demand (e.g. if clinicians do not use the same threshold for referral for day care as for hospital admission).

1.26. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 26 Average total length of stay (antenatal, intrapartum, postnatal) all cases (mothers and babies).

1.27. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 27 Public health cost: average total cost (all cases, includes mothers and babies)(Australian $s).

Patient views on their care were collected in two studies. In the Tuffnell 1992 study, five comparison group and two day unit women felt they had spent too long in hospital (Analysis 1.22). When asked about care in any subsequent pregnancy, 42 of the 45 respondents said they would have been prepared to attend outpatients at least twice a week to avoid hospital admission, and 17 women would have been prepared to attend every day to avoid admission. No women expressed a preference for more inpatient care. In the study by Turnbull 2004, most women in both groups felt they had received good care and were satisfied with it. However, at four days after delivery, overall, significantly more women in the hospital group expressed dissatisfaction with their care compared with those randomised to the day unit (Analysis 1.23). For other measures of dissatisfaction measured at four days, differences between groups were not significant (Analysis 1.24; Analysis 1.25) although in a detailed breakdown of psychosocial outcomes at four days after delivery, the authors report that 12 of 28 items examining satisfaction with care favoured the day care group, and for other items there were no significant differences between groups.

1.22. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 22 Dissatisfaction with care: "spent too much time in hospital".

1.23. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 23 Dissatisfaction with care: "I am satisfied with the care I received" (number disagreeing or not sure).

1.24. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 24 Dissatisfaction with care: "my care was very good" (number not sure or disagreeing).

1.25. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 25 Dissatisfaction with care: "I felt I was being well looked after" (number not sure or disagreeing).

Longer‐term outcomes including maternal anxiety and depression were not reported in these trials.

Non‐prespecified outcomes

One study recorded maternal complications at the birth and in the postnatal period, and again there were no significant differences between groups (Analysis 1.7). This finding held for other maternal outcomes such as high blood pressure recorded at delivery (Analysis 1.8).

1.7. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 7 Maternal complications.

1.8. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 8 Maternal high blood pressure.

Details of readmissions and visits to emergency departments in the postnatal period were reported in the Turnbull 2004 study; differences between groups were not significant (Analysis 1.16; Analysis 1.17).

1.16. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 16 Women requiring readmission after discharge (postnatal).

1.17. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 17 Women visiting emergency department after discharge (postnatal).

Discussion

Summary of main results

Women attending day care units were less likely to be admitted to hospital and, therefore, average length of antenatal admissions were shorter, although outpatient attendances were increased for this group. For most other outcomes there were few differences between groups. Maternal and perinatal outcomes were similar. There was some evidence that women attending for day care were less likely to undergo induction of labour. Changes in the rate of induction of labour are not simple to interpret; the decision to induce may be taken to reduce prolonged observation in hospital and the reduction in length of stay for women in the day care group may thus be underestimated if more women in the hospital group are induced. However, other outcomes including mode of birth were similar for women in both groups, and there were no significant differences in infant birthweight. Length of stay for intrapartum and postnatal care were similar for the two groups. It was not clear that reductions in hospital admissions in the antenatal period resulted in overall cost savings for health service providers.

While most women tended to be satisfied with whatever care they received, women appeared to prefer day care to hospital admission.

Overall completeness and applicability of evidence

Interpreting the findings of this review is not straightforward. The review includes only three trials, and all these were carried out as part of evaluations of new service developments, with possibly new facilities. This could affect the results in different ways. First, when there has been major investment in an innovative new service, it may be difficult for clinical staff and investigators to maintain equipoise. The clinical staff recruited to serve in new services may be particularly enthusiastic; especially if the service represents a new innovation in the care offered by a particular professional group (e.g. a midwifery‐led day care unit). Further, staff that are aware that they are part of a trial evaluating the very service that they are providing may not offer 'routine' care. Both of these may increase the quality of care in the new unit. Conversely, however, staff may not have complete confidence in a new service in which the intensity of care is reduced. This may lead to them regressing to traditional forms of care for the more serious cases. In the Tuffnell 1992 study, there were a number of protocol deviations as some clinical staff preferred to refer women to the day care unit rather than admitting them as inpatients, irrespective of randomisation. Although in this review analysis was by randomisation group, these protocol violations make the results more difficult to interpret.

The aim of antenatal management of hypertension (or preterm premature rupture of membranes) is to reduce the frequency of maternal and fetal adverse outcomes. These, however, are relatively infrequent even in this high‐risk group. In Turnbull 2004, for example, an Apgar score of under seven at five minutes was only reported in 5.1% of women whilst severe hypertension in labour was only seen in 6.6%. Even for these relatively 'soft' outcomes, the studies in this meta‐analysis are hugely underpowered with only 26% and 33% power to detect a reduction of 50% in the rate of low Apgar and severe hypertension respectively (at a 95% significance level). With such small numbers, therefore, it would be unlikely for us to see a statistically significant difference unless the difference were very large. This gives further reason to interpret these results with care.

Day care management in obstetrics and in other medical specialties is now widespread. Observational studies on antenatal day care units have supported the findings of this review in as much as they have suggested that day care offers the potential for cost savings. However, savings are only realised if resources are redeployed and day care does not create new demand. Clinical staff may have lower thresholds for referring women to day care units than for ward admission. Further, management of a discrete episode of care in the antenatal period accounts for only a small part of overall cost. Reduced length of stay on one occasion will only result in cost savings if there is an overall reduction in health service utilisation including, for example, the use of out‐of‐hours, community‐based health services (which was not reported in these trials). Interpreting cost data is further complicated by the wide variation in the cost of care (and in length of hospital stay in the antenatal and postnatal periods) for individual women and their babies; a small number of women and babies may incur very high costs and this may mean that "average" cost data may not be particularly informative.

The results in this review concerning women's views about their care are supported by findings from another non‐randomised study (Twaddle 1995) which found 57% of women prepared to attend day care five times a week to avoid a seven‐day admission and all women were prepared to come at least once. However, some women may prefer hospital admission, and it may be important to offer women choice about the way their pregnancy complication is managed; this may apply especially to those women who have experienced a poor outcome in a previous pregnancy (Duley 2006).

Quality of the evidence

Two of the three studies included in the review had adequate allocation concealment; however, blinding of women and service providers is not possible for this type of intervention and, as we have discussed above, this may lead to some bias in the conduct of trials. This is especially true when a new innovative service is being introduced. In both the intervention and comparison groups, the type of care given in the three studies varied and this means that caution is needed in the interpretation of any pooled results. Further, each trial measured different outcomes in different ways. Outcomes relating to length of stay are particularly difficult to interpret.

Authors' conclusions

Implications for practice.

Randomised trials to date have been too small to assess the effect of day care units on important clinical outcomes. There was, however, some evidence that women preferred day care to hospital admission.

Implications for research.

As day care units are now an accepted part of antenatal services in many areas, it is difficult to carry out further randomised studies. However, the trials included in the review included little information on psychological outcomes for women. Qualitative studies have examined the impact on women of hospital admission during pregnancy, but there has been little work on anxiety and depression for women attending day care units, or on those aspects of service provision which are associated with optimum outcomes or are preferred by women. Such research could underpin further service development in this area.

What's new

Date	Event	Description
12 February 2009	New search has been performed	We updated the search which identified three new trials; two have been included (Hooker 1986; Turnbull 2004) and one excluded (Leung 1998). The background and methods have been updated.
12 February 2009	New citation required and conclusions have changed	The review has been updated by a new review team. The results and conclusions have been revised as a result of the inclusion of new trials. The small studies suggest that there are no major differences in clinical outcomes for mothers or babies between antenatal day units or hospital admission, but women may prefer day care.

History

Protocol first published: Issue 4, 1999
 Review first published: Issue 4, 2001

Date	Event	Description
10 June 2008	Amended	Converted to new review format.

Appendices

Appendix 1. Searching carried out for previous version of this review

Authors searched the Cochrane Controlled Trials Register (Central/CCTR), CINAHL (1982‐04 to 1998‐10), and Current Contents (Life Sciences/Clinical Medicine 1995‐05 to 1999).

Conference proceedings of PSANZ (Perinatal Society of Australia and New Zealand) and FIGO (Fédération Internationale de Gynécologie et d'Obstétrie) (1997) were searched and authors of articles were contacted for a contribution to the search.

Search terms were: day care or assessment or unit* or prenatal care or midwifery or maternity and high‐risk‐pregnancy or pregnancy‐complications‐therapy or preeclampsia.

Data and analyses

Comparison 1. Antenatal day care units versus inpatient care.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Length of antenatal stay	1	54	Mean Difference (IV, Fixed, 95% CI)	‐2.00 [‐5.96, ‐2.04]
2 Women admitted antenatally	2	109	Risk Ratio (M‐H, Fixed, 95% CI)	0.46 [0.34, 0.62]
3 Outpatient hospital visits	1	54	Mean Difference (IV, Fixed, 95% CI)	1.5 [0.54, 2.46]
4 Total antenatal care episodes	1	395	Mean Difference (IV, Fixed, 95% CI)	0.41 [0.05, 0.77]
5 Antenatal hospital stay for less than three days (as either inpatient or staying on the day unit)	1	55	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.64, 1.41]
6 Maternal mortality	2	449	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7 Maternal complications	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
7.1 antenatal (additional)	2	450	Risk Ratio (M‐H, Fixed, 95% CI)	1.30 [0.57, 2.95]
7.2 during labour and birth	1	395	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.63, 1.36]
7.3 postnatal	1	395	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.49, 1.87]
8 Maternal high blood pressure	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
8.1 > 140/90 mmHg at birth	1	395	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.82, 1.17]
8.2 requiring urgent assessment (> 160 mmHg)	1	395	Risk Ratio (M‐H, Fixed, 95% CI)	0.69 [0.38, 1.27]
8.3 medical emergency (> 160/110 mmHg) at birth	1	395	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.32, 1.45]
9 Perinatal mortality	2	449	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
10 Apgar score at five minutes	1	54	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.29, 0.29]
11 Apgar score seven or less at five minutes	1	395	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.38, 2.28]
12 Gestational age at delivery (days)	1	395	Mean Difference (IV, Fixed, 95% CI)	‐1.70 [‐4.40, 1.00]
13 Admission to intensive care unit/special care unit	2	449	Risk Ratio (M‐H, Fixed, 95% CI)	1.81 [0.56, 5.82]
14 Birthweight (grams)	2	448	Mean Difference (IV, Fixed, 95% CI)	‐26.30 [‐135.92, 83.31]
15 Postnatal stay	2	449	Mean Difference (IV, Fixed, 95% CI)	0.14 [‐0.18, 0.47]
16 Women requiring readmission after discharge (postnatal)	1	395	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.22, 1.43]
17 Women visiting emergency department after discharge (postnatal)	1	395	Risk Ratio (M‐H, Fixed, 95% CI)	0.68 [0.35, 1.32]
18 Induction/augmentation of labour	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only
18.1 Induction of labour	1	54	Risk Ratio (M‐H, Random, 95% CI)	0.43 [0.22, 0.83]
18.2 Induction or augmentation of labour	1	395	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.79, 1.13]
19 Normal vaginal birth	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.66, 1.35]
20 Forceps birth	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	1.6 [0.55, 4.68]
21 Caesarean section	1	54	Risk Ratio (M‐H, Fixed, 95% CI)	0.53 [0.10, 2.94]
22 Dissatisfaction with care: "spent too much time in hospital"	1	45	Risk Ratio (M‐H, Fixed, 95% CI)	0.35 [0.08, 1.62]
23 Dissatisfaction with care: "I am satisfied with the care I received" (number disagreeing or not sure)	1	350	Risk Ratio (M‐H, Fixed, 95% CI)	0.40 [0.18, 0.88]
24 Dissatisfaction with care: "my care was very good" (number not sure or disagreeing)	1	348	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.32, 3.34]
25 Dissatisfaction with care: "I felt I was being well looked after" (number not sure or disagreeing)	1	351	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.27, 2.45]
26 Average total length of stay (antenatal, intrapartum, postnatal) all cases (mothers and babies)	1	395	Mean Difference (IV, Fixed, 95% CI)	‐1.31 [‐2.36, ‐0.26]
27 Public health cost: average total cost (all cases, includes mothers and babies)(Australian $s)	1	395	Mean Difference (IV, Fixed, 95% CI)	415.10 [‐603.86, 1434.06]

1.3. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 3 Outpatient hospital visits.

1.9. Analysis.

Comparison 1 Antenatal day care units versus inpatient care, Outcome 9 Perinatal mortality.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Hooker 1986.

Methods	RCT.
Participants	55 women with raised blood pressure and, or pre‐eclampsia, who "would normally have been admitted to hospital for monitoring blood pressure... provided that her condition was not so severe that admission was mandatory". Setting: London hospital, UK, 1984.
Interventions	Intervention group: admission to the day care unit (a side ward of the obstetric unit) with 2‐hourly blood pressure monitoring. Comparison group: hospital admission.
Outcomes	Maternal and perinatal morbidity and mortality, Apgar score, subsequent management.
Notes	Published and unpublished data were used for data extraction.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	"Allocated at random."
Allocation concealment?	Unclear risk	No information provided.
Blinding? Women	High risk	Different care management.
Blinding? Clinical staff	High risk
Blinding? Outcome assessors	High risk
Incomplete outcome data addressed? All outcomes	Unclear risk	55 women were randomised. It was not clear in the results whether all women were accounted for (in the unpublished paper 1 woman with serious morbidity who was not followed up in the study hospital was re‐included in our analyses).
Free of selective reporting?	Unclear risk	Data were derived from a short abstract and unpublished data, little information was provided.
Free of other bias?	Unclear risk	The mean diastolic blood pressure at baseline was higher in the day unit group: 98 versus 94 mm Hg in the comparison group.

Tuffnell 1992.

Methods	RCT. Women were informed of group allocation at recruitment (Zelen's pre‐consent randomisation).
Participants	54 out of 59 eligible women were enrolled in the study and randomised. 30 women were enrolled in the day care group, 24 in the control group. Inclusion criteria: women presenting at 26 weeks of pregnancy or later with non‐proteinuric hypertension (diastolic BP > 90 mm Hg and/or systolic BP >150 mm Hg for 2 readings at least 15 minutes apart). Exclusion criteria: women that had had a previous admission to hospital during the index pregnancy and women with proteinuria or with a diastolic BP > 105 mm Hg or systolic BP > 170 mm Hg. Setting: hospital in Leeds, UK in 1989. All women randomised completed the trial.
Interventions	Intervention group: patients referred to the day unit were seen the morning after referral. 5 BP readings were made; urine was checked for protein; platelet count and serum urate concentration were measured; and a cardiotocograph was done. Doppler waveform analyses were done if considered necessary by the clinician. After each visit the woman was reviewed, and further visits were arranged according to perceived clinical need; either discharged back to clinic, followed up in the day unit, or admitted to hospital. Comparison group: patients in the control group were managed according to the judgement and established practice of the referring clinician. This did not necessarily entail admission to the hospital. In the experimental group, 16 women were admitted to hospital without further review, 5 were reviewed by the community midwife 48‐96 hours later and 3 were given appointments to the next antenatal clinic. 3 patients allocated to the control group were referred to the day unit.
Outcomes	A record was kept of the woman's blood pressure, weight and stage of gestation at referral, and the action taken after randomisation. Outpatient attendance and admissions and the proportion of time in hospital were recorded prospectively from day of entry to the study to delivery. Clinical complications, the method of management, and labour and delivery details were recorded. Patient satisfaction was assessed by a confidential postal questionnaire sent to all women 4 to 6 weeks after delivery.
Notes	Economic analyses were performed but not published. Sample size of 25 women in each arm of the study would have an 80% chance of detecting a 50% reduction in duration of stay at P < 0.05 with a 1‐tailed test. 5 eligible women did not enter the study, and were not randomised, because the referring doctors preferred to use the day care unit.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Decribed as "simple randomisation".
Allocation concealment?	Low risk	Sealed opaque sequentially numbered envelopes opened by midwife who had had no previous contact with the women.
Blinding? Women	High risk	Care options were discussed with the women (Zelen randomisation ‐ randomisation before consent, no women withdrew after randomisation).
Blinding? Clinical staff	High risk	Different care protocols.
Blinding? Outcome assessors	High risk	Case notes would have revealed group allocation.
Incomplete outcome data addressed? All outcomes	Unclear risk	Full data available for outcomes collected during the antenatal period and for delivery. 9 women, 3 in the control group and 6 in the intervention group, did not return postal questionnaires about patient satisfaction (17% attrition) which was completed 4‐6 weeks after delivery.
Free of selective reporting?	Low risk	None apparent. Non‐significant findings reported.
Free of other bias?	Unclear risk	The mean systolic BP was slightly higher in the comparison group (day care group mean 140 (SD 8) comparison group mean 134 (SD 9).

Turnbull 2004.

Methods	Parallel RCT; Zelen design with double consent.
Participants	395 women being admitted to the day care unit as an alternative to hospital admission. Inclusion criteria: women with 3 clinical disorders (proteinuric hypertension, non‐proteinuric hypertension or PPROM after 28 weeks) for which there was no clear clinical indication for inpatient admission or any indication of fetal compromise. A woman with PPROM at 28 weeks' gestation or later was considered for inclusion if initial assessment indicated that labour was not imminent, there were no signs of infection or haemorrhage, she lived within 40 minutes of the hospital and she had been an inpatient for less than a week. (Indications for immediate admission: systolic blood pressure > 160 mmHg, diastolic blood pressure > 110 mmHg, proteinuria of +++ or more on dipstick testing; any clinical indication of irritability of the central nervous system or splanchnic congestion; any biochemical signs of organ dysfunction (such as abnormal liver or renal function test results or evidence of haemolysis or thrombocytopenia)). Exclusion criteria: women presenting for cardiotocography alone were excluded; also multiple pregnancy, inability to communicate in English, and previous admission in the current pregnancy for the presenting complication. Setting: tertiary women's hospital, Adelaide, Australia.
Interventions	Intervention group: day care unit. Unit with sitting and dining areas and a "deinstitutionalised environment". Families were able to accompany women. The unit was open between 09.00 to 17.00 hrs. Tests were initiated on admission with review after 2‐3hours. Comparison group: admission to medical ward with limited visiting hours and a stay of at least 1 night.
Outcomes	Clinical outcomes, maternal satisfaction with care and psychological wellbeing (questionnaires 4 days after randomisation and 7 weeks post delivery). Economic data.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	External randomisation by computer‐generated sequence.
Allocation concealment?	Low risk	Third party telephone randomisation (Zelen method, patients randomised before final consent).
Blinding? Women	High risk	Women aware of treatment alternatives.
Blinding? Clinical staff	High risk	Different care packages.
Blinding? Outcome assessors	High risk	Some data extraction from notes was carried out by midwives not providing care but the notes are likely to have included details of management.
Incomplete outcome data addressed? All outcomes	Low risk	26 women (7%) did not receive care according to the allocation but they were analysed by randomisation group. Low rates of attrition for outcomes collected from notes (< 5%). The response rate for women's questionnaires 4 days post randomisation was relatively high (approximately 88%).
Free of selective reporting?	Low risk	None apparent, but pre‐specified outcomes were very broad (e.g. that day care units would result in "no difference in clinical outcome").
Free of other bias?	Low risk	Both groups had similar baseline characteristics, although there were slightly more smokers in the comparison group (14.4%) compared with the day care group (12.5%).

BP: blood pressure 
 hrs: hours 
 mmHg: millimetres of mercury 
 PPROM: premature, prelabour rupture of the membranes 
 RCT: randomised controlled trial 
 SD: standard deviation

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Leung 1998

This study compared inpatient versus outpatient management of raised diastolic blood pressure. The inpatient group were admitted on the day of recruitment to the study or on the next day. The intervention group included 2 groups of women who were managed in different ways: (i) women were referred to a day care unit where they had a protocol for monitoring women's condition including urine analysis and blood pressure checks and 4 hours' bed rest, OR (ii) women were assessed in the antenatal clinic which had no facilities for bed rest, cardiotography or ultrasound. Women in both groups were given urine testing equipment to use on discharge home. The study was excluded as separate results were not provided for women attending the day care unit. It was not clear how many women in the outpatient group attended the day care unit or whether women in the two outpatient groups had similar characteristics.

Differences between protocol and review

The Background and Methods have been updated.

Contributions of authors

Philippa Middleton carried out data extraction, assessed risk of bias and contributed to drafting the text of the review. Therese Dowswell carried out data extraction, assessed risk of bias, entered and checked data and contributed to drafting the text of the review. Andrew Weeks revised text and commented on drafts of the review.

Sources of support

Internal sources

• The University of Adelaide, Australia.

• The University of Liverpool, UK.

External sources

• The Australian Department of Health and Ageing, Australia.

• National Institute for Health Research (NIHR), UK.

  NIHR NHS Cochrane Collaboration Programme grant scheme award for NHS‐prioritised centrally managed, pregnancy and childbirth systematic reviews: CPGS02

Declarations of interest

None known.

New search for studies and content updated (conclusions changed)