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The effectiveness of antenatal care programmes to reduce infant mortality and preterm birth in socially disadvantaged and vulnerable women in high-income countries: a systematic review.
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PMID:  21314944     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Infant mortality has shown a steady decline in recent years but a marked socioeconomic gradient persists. Antenatal care is generally thought to be an effective method of improving pregnancy outcomes, but the effectiveness of specific antenatal care programmes as a means of reducing infant mortality in socioeconomically disadvantaged and vulnerable groups of women has not been rigorously evaluated.
METHODS: We conducted a systematic review, focusing on evidence from high income countries, to evaluate the effectiveness of alternative models of organising or delivering antenatal care to disadvantaged and vulnerable groups of women vs. standard antenatal care. We searched Medline, Embase, Cinahl, PsychINFO, HMIC, CENTRAL, DARE, MIDIRS and a number of online resources to identify relevant randomised and observational studies. We assessed effects on infant mortality and its major medical causes (preterm birth, congenital anomalies and sudden infant death syndrome (SIDS)) RESULTS: We identified 36 distinct eligible studies covering a wide range of interventions, including group antenatal care, clinic-based augmented care, teenage clinics, prenatal substance abuse programmes, home visiting programmes, maternal care coordination and nutritional programmes. Fifteen studies had adequate internal validity: of these, only one was considered to demonstrate a beneficial effect on an outcome of interest. Six interventions were considered 'promising'.
CONCLUSIONS: There was insufficient evidence of adequate quality to recommend routine implementation of any of the programmes as a means of reducing infant mortality in disadvantaged/vulnerable women. Several interventions merit further more rigorous evaluation.
Authors:
Jennifer Hollowell; Laura Oakley; Jennifer J Kurinczuk; Peter Brocklehurst; Ron Gray
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Review     Date:  2011-02-11
Journal Detail:
Title:  BMC pregnancy and childbirth     Volume:  11     ISSN:  1471-2393     ISO Abbreviation:  BMC Pregnancy Childbirth     Publication Date:  2011  
Date Detail:
Created Date:  2011-03-09     Completed Date:  2011-07-12     Revised Date:  2013-06-30    
Medline Journal Info:
Nlm Unique ID:  100967799     Medline TA:  BMC Pregnancy Childbirth     Country:  England    
Other Details:
Languages:  eng     Pagination:  13     Citation Subset:  IM    
Affiliation:
National Perinatal Epidemiology Unit, University of Oxford, Old Road Campus, Oxford, OX3 7LF, UK. jennifer.hollowell@npeu.ox.ac.uk
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MeSH Terms
Descriptor/Qualifier:
Developed Countries / statistics & numerical data*
Humans
Infant
Infant Mortality*
Infant, Newborn
Premature Birth*
Prenatal Care / methods*
Program Evaluation
Socioeconomic Factors
Vulnerable Populations / statistics & numerical data*
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ID/Acronym/Agency:
//Department of Health
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Journal ID (nlm-ta): BMC Pregnancy Childbirth
ISSN: 1471-2393
Publisher: BioMed Central
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Copyright ©2011 Hollowell et al; licensee BioMed Central Ltd.
open-access:
Received Day: 25 Month: 11 Year: 2010
Accepted Day: 11 Month: 2 Year: 2011
collection publication date: Year: 2011
Electronic publication date: Day: 11 Month: 2 Year: 2011
Volume: 11First Page: 13 Last Page: 13
ID: 3050773
Publisher Id: 1471-2393-11-13
PubMed Id: 21314944
DOI: 10.1186/1471-2393-11-13

The effectiveness of antenatal care programmes to reduce infant mortality and preterm birth in socially disadvantaged and vulnerable women in high-income countries: a systematic review
Jennifer Hollowell1 Email: jennifer.hollowell@npeu.ox.ac.uk
Laura Oakley1 Email: laura.oakley@npeu.ox.ac.uk
Jennifer J Kurinczuk1 Email: jenny.kurinczuk@npeu.ox.ac.uk
Peter Brocklehurst1 Email: peter.brocklehurst@npeu.ox.ac.uk
Ron Gray1 Email: ron.gray@npeu.ox.ac.uk
1National Perinatal Epidemiology Unit, University of Oxford, Old Road Campus, Oxford, OX3 7LF, UK

Background

In recent years, infant mortality in most parts of the world has shown a steady decline [1]. Across high-income OECD countries as a whole, the average infant mortality rate declined from 12.2 deaths per 1000 live births in 1980 to 4.9 deaths per 1000 live births in 2008; and in the United Kingdom the rate showed a similar decline, from 12.1 deaths per 1000 live births in 1980 to 4.9 deaths per 1000 live births in 2008. But throughout this period infant mortality has shown marked and persistent socioeconomic gradients within countries, even in countries with universal healthcare access [2-4]. Immaturity related conditions and congenital anomalies are the two main causes of infant deaths in high-income countries [5-7]; and for both of these causes mortality rates exhibit socioeconomic gradients with the highest rates occurring in the most socioeconomically disadvantaged groups [8,9]. A number of so-called vulnerable groups also suffer disproportionately high rates of infant mortality (and other adverse perinatal outcomes), or have a high prevalence of risk factors for poor pregnancy outcome/infant health: such groups include teenagers[5,10], many black and minority ethnic groups [10,11], homeless women [12,13], prisoners [12,14], women who have experienced domestic violence [15], asylum seekers and refugees [12], women with mental illness [16] and women with substance abuse problems [12,17,18].

A review of the international effectiveness literature conducted at the NPEU in 2008 (updated in 2009 [19]) confirmed the paucity of relevant systematic review level evidence relating to infant mortality and related outcomes in disadvantaged populations; and a review of UK interventions to improve perinatal outcomes in disadvantaged groups found limited UK evidence of effective interventions for disadvantaged childbearing women [12].

Antenatal care is generally thought to be an effective method of improving outcomes in pregnant women and their babies, although many antenatal care practices have not been subject to rigorous evaluation [20]. One review from the early 1990 s evaluated 'prenatal care packages' [21] but found only five studies of adequate quality which evaluated the effect of the programme on gestational age at birth and/or infant mortality, two of which (Nurse Home Visitation [22]; and case management [23]) were found to have a positive effect on the relevant outcome measure.

Other systematic reviews have evaluated the effect of specific antenatal care packages on preterm birth (PTB) and infant mortality, including: alternative ways of delivering antenatal care to Australian indigenous women [24]; telephone support and home visiting programmes [25,26]; continuity of caregiver during pregnancy and childbirth [27,28]; and modified timing and frequency of antenatal care visits [29-31].

These reviews found that telephone support [25], home visits/social support [25,26] and continuity of care [27,28] had beneficial effects on a range of measures of maternal and infant health and wellbeing, but none of these interventions was found to have a statistically significant effect on infant mortality or PTB. One review [24] found some studies that reported beneficial effects of some interventions targeting Australian indigenous women, but the authors of the review concluded that the evidence was flawed.

In the light of the paucity of up to date evidence relating to the effectiveness of antenatal care programmes as a means of reducing infant mortality in disadvantaged groups of women, the aim of this systematic review was to identify the best available evidence on the effectiveness of interventions focused on the delivery and organisation of antenatal care to reduce infant mortality, or one of its three major causes (PTB, congenital anomalies, sudden infant death syndrome/sudden unexpected death in infancy (SIDS/SUDI)) in socially disadvantaged and vulnerable groups of women and other specific groups, such as teenagers and substance abusers, with risk factors for adverse birth outcomes strongly associated with social disadvantage.


Methods

Because the review findings were aimed at policy makers and healthcare managers, our approach incorporated some of the iterative methods of interpretive synthesis proposed by Lomas and others for policy research synthesis[32]: the research question, PICO criteria and methods for the identification and screening of studies were pre-specified but decisions regarding how best to analyse and present findings from the included studies were taken iteratively by the authors in the light of the available material.

Criteria for including studies in the review

Criteria for including studies in the review are summarised in Table 1.

Methods for identification of studies

We searched the following databases in mid-August 2008 for reports of primary research studies published between January 1990 and July 2008: Medline, Embase, Cinahl, PsycINFO, HMIC, CENTRAL, Database of Abstracts of Reviews of Effects (DARE), MIDIRS. We used a search strategy which combined MeSH terms/keyword and text search terms relating to the outcomes, interventions and populations of interest (See additional file 1).

We additionally searched a number of other specialist databases, including the Cochrane Database of Systematic Reviews, and online resources (see additional file 1 for list) to identify potentially eligible primary reports and also review articles, guidelines, and other reports that might contain relevant citations. The bibliographies of the latter were inspected to identify relevant primary reports.

Two reviewers independently assessed titles/abstracts of all potentially relevant/eligible references using a simple checklist of exclusion criteria. The full-text of articles not excluded on title/abstract was screened independently by two reviewers using a more detailed checklist of exclusion and inclusion criteria. At both stages, discrepancies were discussed and the opinion of a third reviewer sought where necessary to reach a final decision regarding eligibility.

Quality assessment

Internal validity was assessed using the 'Graphical appraisal tool for epidemiological studies' (GATE) developed by Jackson and colleagues [33]. GATE is a generic quality appraisal tool which can be applied to a wide range of experimental and observational study designs [34] and thus avoided the need to use different tools according to the study design.

Randomised studies were assessed by a single reviewer; observational studies were assessed independently by two reviewers. Each reviewer completed the checklist and assigned an overall assessment of internal validity according to the GATE criteria. Where the two assessments (observational studies only) differed, a third reviewer re-assessed the studies and a final rating was assigned following review and discussion of the three independently completed checklists. Risk of bias was assessed at the outcome level (PTB or infant mortality); where both PTB and infant mortality were reported, the assessment was based on the outcome considered to be the 'primary outcome'.

Prior to undertaking the study GATE assessments, reviewers completed and discussed a minimum of five 'training assessments' to ensure that the tool was being correctly and consistently applied.

Data extraction

A data extraction and coding form was developed and loaded into specialist review software (Eppi-Reviewer[35]). Descriptive data were extracted and entered by one reviewer and checked by a second reviewer. Outcome data were extracted and coded/entered independently by two reviewers and checked for agreement.

Assessment of evidence of effectiveness

Two reviewers independently assessed and coded the authors' conclusions regarding the effect of the intervention on the outcomes of interest. For each of the outcomes reported, conclusions were coded as follows: (a) statistically significant effect on the outcome; (b) effect consistent with a beneficial effect but effect not statistically significant and/or cautious interpretation of findings recommended; (c) no evidence of beneficial effect; (d) no conclusion stated.

For studies having 'adequate' internal validity ('good' or 'mixed' GATE quality assessment), the reviewers also independently assessed and coded the evidence of effectiveness for individual outcomes, taking into account the strength and limitations noted in the GATE checklist. Evidence of effectiveness was coded as follows: (a) study demonstrates a beneficial effect on the outcome; (b) study inconclusive but suggestive of a beneficial effect; (c) study does not provide convincing evidence of a beneficial effect.

Discrepancies in coding were resolved by discussion with a third reviewer.


Results
Studies included

Our initial searches identified 3736 unique citations. Of these, 3597 were excluded on title/abstract alone and a further 103 were excluded following full-text review. (See additional file 2 for reasons for exclusion.) Four new articles were identified from reference lists and citations. In total, 40 eligible articles were included (see Figure 1) relating to 36 distinct interventions and/or studies. Two of the four 'secondary' reports, did not provide additional relevant data [36,37] (and are not considered further); and two provided additional data supplementing those provided in the 'primary' reports (one reported additional data on neonatal mortality [38] and one reported effectiveness data for a subgroup of interest [39]).

The characteristics of the 36 included primary studies are shown in Table 2.

Outcomes evaluated

All included studies reported PTB/preterm labour and/or a measure of neonatal/infant mortality as an outcome (Table 2). Six studies [40-45] additionally reported congenital anomalies: this outcome is not considered further in this review because the low event rate, small combined sample size across studies and diversity of interventions meant that no conclusions could be drawn regarding intervention effects on this outcome. None of the included studies evaluated effects on SIDS/SUDI.

Quality of evidence

Eight of the nine included randomised controlled trials (RCTs) were assessed as having 'adequate' ('good' or 'mixed') internal validity, and one was rated 'poor'. Of the 27 primary observational studies, six were assessed as having 'adequate' internal validity (none 'good'; 6 'mixed') and 21 as 'poor' (See additional file 3).

Overall, fifteen of the studies (14 primary studies [23,41-43,46-55] and one secondary report providing supplementary data[38]) were considered to have 'adequate' internal validity.

Interventions

Twenty studies related to interventions targeting and/or evaluated in socioeconomically disadvantaged/deprived populations of which eight were aimed specifically at disadvantaged women with additional clinical risk factors for PTB or LBW. Seventeen of these studies were conducted in the USA, with most targeting medically indigent and/or Medicaid eligible women.

The other sixteen primary studies related to interventions targeting or evaluated in specific vulnerable population: nine targeted pregnant teenagers, four targeted pregnant substance users, two targeted pregnant indigenous Australians, and one intervention targeted pregnant women who were HIV positive. One further secondary report [38] provided data on the effectiveness of the latter intervention in a sub-group of substance using, HIV positive women.

Twenty-three of the studies evaluated alternative of models of delivering comprehensive antenatal care and 13 evaluated interventions provided as an adjunct to comprehensive antenatal care, including home visiting, nutritional programmes, case management/care coordination and substance abuse programmes provided alongside standard antenatal care. An overview of the intervention characteristics by target population is given in additional file 4. A more detailed description of the interventions is available elsewhere [19].

The fifteen studies assessed as having adequate internal validity are described in Tables 3 and 4.


Effectiveness
Comprehensive antenatal care programmes

Eight studies of adequate quality evaluated comprehensive antenatal care programmes. Results are summarized in Table 5.

a) Programmes targeting socioeconomically disadvantaged women without specific clinical risk factors for PTB/LBW

Two linked studies reported by Ickovics [49,50] evaluated the group antenatal care model in disadvantaged populations: the first an observational study conducted in clinics serving low-income, predominantly minority women in Atlanta, Georgia and New Haven, and the second a larger RCT conducted at university-affiliated hospitals in Connecticut and Georgia. The initial evaluation was inconclusive, largely because of the potential risk of selection bias. The subsequent trial reported a significant reduction in PTB in the group care arm (adjusted odds ratio 0.67, 95% confidence interval (CI) 0.44-0.98).

An observational evaluation of the Temple Infant and Parent Support Services (TIPPS) programme [54], a 'customised' comprehensive multidisciplinary service designed to meet the specific needs of the local population in North Philadelphia, Pennsylvania, reported a statistically significant effect on PTB (4.3% vs. 12% preterm in those not enrolled in TIPPS). Because of the risk of selection bias the reviewers considered the findings inconclusive but consistent with a possible beneficial effect.

One study, a before and after study with a contemporaneous comparison group, evaluated a 'managed care' model of delivering antenatal care (the Tennessee Medicaid Managed Care programme (TennCare)) in one US state (Tennessee) against a standard antenatal care model in an adjacent state (North Carolina) [47]. Outcomes (PTB and infant mortality) in the before and after periods did not show any relative improvement in the intervention area compared with the 'control' area. The study did not provide evidence of a beneficial effect of managed care on either PTB or neonatal mortality although some implementation problems occurred during the evaluation which may have affected the outcome.

b) Programmes providing enhanced antenatal care to socioeconomically disadvantaged women with additional clinical risk factors for PTB/LBW

A cluster randomized trial of the West Los Angeles Preterm Prevention Project [48], a broad, multi-faceted PTB prevention programme, reported a statistically significant reduction in PTB, based on a one-sided test for an intervention effect (7.4% PTB in the intervention clinics vs. 9.1% in the control clinics, p = .063 (two-sided), p = .045 (one-sided); adjusted odds ratio 0.78, two-sided 95% CI 0.58-1.04). Because the effect was of borderline statistical significance and there were concerns about aspects of the statistical methods (see additional file 3), findings were considered inconclusive by the reviewers but consistent with a possible beneficial effect of the intervention on PTB.

An RCT of an augmented antenatal programme in Alabama [43] reported a non-significant reduction in PTB (10.6% PTB vs. 14%, p = 0.22). Findings were considered inconclusive.

c) Programmes targeting other vulnerable/at risk groups

An observational evaluation of the New York Prenatal Care Assistance Program (PCAP) in HIV positive women [55] reported a significant effect on PTB (<37 weeks) in HIV positive women attending a PCAP-accredited clinic compared with those who received care in a non PCAP-participating clinic (adjusted odds ratio 0.53, 95% CI 0.40-0.70).

A second overlapping observational evaluation of the same programme in HIV positive substance users [38] reported a significant effect on PTB (<37 weeks) compared with HIV positive substance users who received care in a non-PCAP participating clinic (adjusted odds ratio 0.57, 95% CI 0.34-0.97).

In both cases, the reviewers considered that the evidence was inconclusive due to the risk of selection bias in these non-randomised studies but consistent with a possible beneficial effect of PCAP on PTB in both the populations studied.

Programmes provided as an adjunct to comprehensive antenatal care

Results of the seven studies of adequate quality which evaluated interventions provided as an adjunct to standard antenatal care are summarised in Table 6.

a) Interventions aimed at socioeconomically disadvantaged women

Three studies evaluated programmes aimed at socioeconomically disadvantaged women in general: two evaluated home visiting programmes and one evaluated maternity care coordination.

A cluster RCT evaluating the antenatal component of a home visiting programme with a focus on nutritional education, delivered to an isolated rural population (Florina) in Northern Greece [42], reported a significant effect on PTB (3.7% PTB in the intervention group vs. 8.3% in the comparator group, p < 0.04). Because the effect was of borderline statistical significance and there were concerns about aspects of the statistical methods (see additional file 3), findings were considered inconclusive but consistent with a possible beneficial effect of the intervention on PTB.

A well-designed RCT to evaluate the antenatal home visiting component of the Prenatal and Early Childhood Nurse Home Visitation Program in multi-disadvantaged, black, low-income women in Tennessee [51], found no evidence of a beneficial effect on PTB (11% PTB in the intervention group vs. 13% in the comparator group; adjusted odds ratio 0.8 (95% CI 0.6-1.2)).

A large retrospective observational evaluation of a maternity care coordination programme provided to Medicaid recipients in North Carolina [23] reported a statistically significant effect on infant mortality (adjusted odds ratio 1.20, 95% CI 1.47-0.98). Because of the risk of residual confounding, the reviewers considered the findings inconclusive but consistent with a possible beneficial effect of the intervention on infant mortality.

b) Interventions aimed at or evaluated in socioeconomically disadvantaged women with additional risk factors for PTB/LBW

Three studies evaluated home visiting/telephone support programmes provided to women with additional risk factors for PTB/LBW.

An RCT of antenatal support delivered through home visits and telephone calls to women with a prior PTB or other risk factors for PTB in Western Australia [46] did not demonstrate a significant beneficial effect on PTB in a socioeconomically mixed population of higher risk women (odds ratio 0.84; 95% CI 0.65-1.09); a stratified analysis by social class suggested that the beneficial effect, if any, was confined to the most advantaged women in the study. Odds ratios for women classified as 'clerical' and 'manual' were close to one.

An RCT of an intervention involving telephone assessment/advice in North Carolina [52] also found no significant beneficial effect on PTB overall but reported a beneficial effect in a subgroup of black women aged > = 19 years (relative risk 0.56, 95% CI 0.38-0.84, p = 0.004). It is unclear if the sub-group analysis by age and ethnicity was pre-specified. The study was not considered to provide evidence of a beneficial effect overall; the subgroup analysis was considered inconclusive but consistent with a possible beneficial effect in black women aged > = 19.

An RCT of a nurse home visiting programme in the UK, aimed at socioeconomically disadvantaged women with a prior LBW birth [53], similarly found no effect on PTB (18% PTB in the intervention group vs. 19% in the usual care arm; odds ratio not reported).

c) Interventions evaluated in other vulnerable/at risk groups

An observational evaluation of a nutritional programme, the Higgins Nutrition Intervention Program, in adolescents [41] reported a substantial, statistically significant effect on PTB (<37 weeks) (adjusted odds ratio 0.59, 95% CI 0.45-0.78) and on early PTB (<34 weeks) (adjusted odds ratio 0.53, 95% CI 0.35-0.81). Although the study was inconclusive due to the risk of selection bias, the reviewers considered the findings consistent with a possible beneficial effect on PTB.


Discussion

The purpose of this review was to evaluate the effectiveness of interventions focused on the delivery or organisation of antenatal care as a means of reducing infant mortality or its three major causes (PTB, congenital anomalies, SIDS/SUDI) in disadvantaged and vulnerable women.

We identified 36 primary reports of eligible studies evaluating interventions in a range of disadvantaged and vulnerable populations including socioeconomically disadvantaged/low-income women in general, socioeconomically disadvantaged/low-income women with additional clinical risk factors for adverse pregnancy outcome, and four other specific groups at risk of adverse pregnancy outcome: teenagers, substance users, indigenous women and HIV positive women.

Overall, the quality of evidence was poor and, for most of the interventions considered, there was insufficient evidence to evaluate consistency of findings across multiple studies. Less than half of the included evaluations were considered to have 'adequate' internal validity. Even for interventions shown to be effective in higher quality studies, such as group antenatal care, we considered that the evidence was too sparse to reliably conclude that the interventions were effective in reducing PTB or neonatal mortality in the disadvantaged and vulnerable populations considered, or that the findings could be generalised to other disadvantaged populations.

We concluded that the evidence relating to seven interventions, although inconclusive, indicated a possible beneficial effect on PTB or on infant mortality.

The following four models of comprehensive antenatal care were considered promising:

• Findings of one well-conducted RCT [49] suggested that group antenatal care might reduce PTB in socioeconomically disadvantaged women. A cohort study evaluating the same model of group antenatal care [50] did not show a consistent beneficial effect on PTB, but the study was too small to detect an effect on this outcome. The group antenatal care model is well defined and described and would appear to be transferable to non-US healthcare systems.

• Trials of two broad, multifaceted, clinic-based PTB prevention programmes targeting disadvantaged women with additional clinical risk factors for PTB suggested that such interventions might be effective in reducing PTB. The two interventions evaluated [43,48] were not identical but appeared to share the common approach of targeting a broad range of risk factors in women identified as being at higher-risk. Such programmes would potentially be transferable to non-US healthcare systems, although only one of the two reports provided sufficient detail to enable replication of the main elements of the programme [43].

• The intensive, multi-component TIPPS programme evaluated by Reece [54] was considered promising with regard to possible effects on PTB despite methodological limitations of the evaluation. The TIPPS intervention itself was designed specifically to address the problems and needs of a disadvantaged local population in North Philadelphia and it is unclear whether the intervention is transferable or the findings generaliseable to other setting. However, some elements of the intervention and the need-based approach to developing 'locally customised' services may merit further examination and evaluation.

• The two overlapping evaluations of the New York Prenatal Care Assistance Program (PCAP) [38,55] suggested that the PCAP programme might be effective in reducing PTB in HIV positive women, some of whom were drug users. The programme aims to improve outcomes by improving the quality of care through a process of clinic accreditation with financial incentives to 'accredited' providers. The effect of PCAP on other outcomes has also been evaluated in a wider population of socioeconomically disadvantaged women [56]. The use of enhanced payments to providers providing enhanced services is potentially transferable to other healthcare systems but it is unclear whether the specific services covered by PCAP accreditation would be relevant in other settings.

Three interventions provided as an adjunct to standard antenatal care were also considered promising:

• Two nutritional programmes were tentatively considered promising. An evaluation of the Higgins Nutrition Intervention Program in pregnant teenagers indicated a possible beneficial effect on PTB in this population, despite the methodological limitations of the study [41]; and the evaluation of a home visiting programme focussing on nutritional education (the Florina Intervention Program) also suggested a possible beneficial effect on PTB in a low-income rural population in Greece [42,57]. The Florina Intervention Program was evaluated in isolated agricultural population in Greece with a low-calorie, seasonal diet based on home produce and domestic livestock [57]; the relevance and generalisability of the nutritional elements of the intervention to more urbanised populations is unclear.

• A single US-based study indicated that maternity care coordination might have a beneficial effect on infant mortality in socially disadvantaged women in the USA [23]. However, it is unclear to what extent these findings can be generalised to other healthcare systems since some elements of the intervention may be specific to the healthcare and welfare systems in the USA.

Although we identified seven studies evaluating 'teen' clinics, no conclusions could be drawn regarding the effectiveness of such clinics because of problems of study design and selection bias in the included studies.

We found insufficient evidence of adequate quality to draw any conclusions regarding the effectiveness of the other interventions evaluated.

Strengths and limitations of this systematic review

In line with our aim to identify the best available evidence on antenatal care interventions targeting socially disadvantaged and vulnerable women we did not restrict ourselves to particular study designs and we designed our searches to reflect this breadth of interest. This lack of specificity may be seen as both strength and a weakness of this review.

The inclusion of less methodologically rigorous evaluations increased the volume of material identified and reviewed and also presented methodological challenges with regard to quality assessment. Furthermore, in practice, it did not add greatly to the evidence regarding effectiveness. Nevertheless, the inclusion and systematic quality appraisal of such evaluations may have served the useful function of highlighting the lack of robust evidence supporting the effectiveness of some widely studied interventions, e.g. 'teen' clinics.

The decision to review a broad category of interventions-antenatal care programmes involving the delivery or organisation of antenatal care-rather than identifying specific interventions a priori, has enabled us to provide an overview of a wide range of interventions. A more focussed approach examining a smaller range of specific interventions would have been more consistent with standard systematic reviewing methods, although developing and applying precise interventions definitions-required to ensure reproducible selection of studies-would potentially have been challenging. Furthermore, such an approach would have lacked the flexibility to review a broad, rather diffuse and poorly defined evidence base which was possible with our more comprehensive approach. However, a disadvantage is that a more comprehensive approach necessitates a degree of post hoc decision making [32]. For example, following our initial searches we had to decide how best to classify and group the interventions. It is possible that different ways of classifying and grouping the interventions might have changed the 'weight of evidence' in favour of an intervention within scope of the review, but, given the limitations of the evidence, we think it unlikely that this would have resulted in major changes to our conclusions.

An unanticipated consequence of our 'generic' inclusion/exclusion criteria was the exclusion of some seemingly relevant interventions provided as an 'add on' to normal antenatal care. For example, studies relating to some welfare-based US programmes (such as the Special Supplemental Food Program for Women, Infants and Children (WIC)) were excluded not because the intervention was ineligible but because studies evaluating the intervention typically compared 'intervention recipients' with 'non-recipients', with the latter group including women who received no antenatal care. The studies were therefore excluded because they lacked a comparator group receiving standard antenatal care.

It is possible that we may have missed some relevant 'add on' interventions as a result of using non-specific antenatal care search terms (e.g. 'prenatal care') instead of more intervention specific terms. Similarly, socioeconomically disadvantaged study populations are not consistently indexed or mentioned in searchable elements of the bibliographic record. We took some additional steps to increase ascertainment of relevant material, including using an adapted version of an 'equity filter' (developed by the EPPI-Centre to identify material relating to health inequalities) in our searches, and 'snowballing' [58].

Although the titles of articles lacking an abstract were screened and the full-text retrieved where appropriate, there is the possibility that relevant studies lacking an abstract may have been missed; non-English language articles lacking an English abstract were not included.

Findings in relation to other published evidence

One previous review conducted in the early 1990 s sought to evaluate the "best" evidence relating to the effect of antenatal healthcare programmes on pregnancy outcomes, including infant mortality and gestational age at birth [21]. The authors concluded that maternal care coordination, home visits by nurses and specially targeted smoking and nutritional programmes were associated with "optimized pregnancy outcomes for certain groups of women, including the poor and very young." Nevertheless, as in the present review, and for similar reasons, they urged caution in applying these findings.

Other published reviews have addressed the effectiveness of a range of specific antenatal care interventions but most without a focus on effectiveness in disadvantaged or vulnerable groups of pregnant women:

PTB prevention educational programmes for high risk women A systematic review and meta-analysis of RCTs of PTB prevention educational programmes [59] concluded that they appeared to have little benefit in reducing PTB and might result in an increased rate of diagnosis of preterm labour.

Home visiting programmes A review of the effect of home visits on a range of pregnancy outcomes including PTB (<37 weeks) [26] found that home visiting programmes in general, and more specific programmes (those providing social support and those providing medical care to women with complications) did not improve the preterm delivery rate or other pregnancy outcomes. A second review of interventions involving support during pregnancy for women at increased risk of LBW babies [60], found no effect on PTB (Risk ratio 0.92, 95% CI 0.83 - 1.01). A further 'review of reviews' [61] similarly concluded that there was insufficient evidence to suggest that home-visiting programmes had a beneficial impact on low birth weight or other pregnancy outcomes.

Telephone support A recent review of telephone support interventions concluded that they were ineffective at reducing PTB [25].

Nutritional interventions A review of the effectiveness of interventions to optimize gestational weight gain and diet in pregnant adolescents [62] concluded that such interventions had achieved "promising results" with regard to a range of pregnancy outcomes but found little evidence relating to effects on PTB. The review did not systematically assess the quality of the included material but noted that much of the evidence was methodologically flawed. A further review assessed the effects of a range of nutritional interventions during pregnancy, including advice to increase or reduce energy or protein intake [63]. The authors concluded that although dietary advice appeared to be effective in increasing pregnant women's energy and protein intakes it was unlikely to confer major benefits on infant or maternal health. These findings do not support our tentative conclusions regarding the potentially 'promising' effect of the two programmes with a nutritional focus included in the present review (the Higgins nutritional intervention in teenagers [41], and the Florina home visiting programme which has a nutritional counselling focus [42]) and, on balance, may suggest that a more cautious interpretation of the evidence in favour of these two interventions would be warranted.

Midwife-led antenatal care A Cochrane review [64] did not find a significant beneficial effect of midwife-led antenatal care on PTB compared with other models of care (risk ratio 0.87, 95% CI 0.73-1.04). A second overlapping review of continuity of midwifery care vs. standard care [28] additionally found no significant effect on neonatal mortality (odds ratio 1.27, 95% CI 0.49 - 3.34). A third review examined the evidence relating to various aspects of antenatal care for low-risk women including the effectiveness of midwife/general practitioner-managed care vs. obstetrician/gynaecologist-led shared care [30] also found no significant effect on PTB (relative risk 0.80, 95% CI 0.59 - 1.10).

Antenatal care targeting specific vulnerable groups Rumbold and Cunningham reviewed the impact of antenatal care interventions on Australian indigenous women [24]. They did not assess the quality of the included studies so the interpretation of their findings is uncertain.

With the exception of the findings relating to the possible ineffectiveness of nutritional interventions noted above, the findings of other published reviews appear consistent with our assessment of the effectiveness of antenatal care programmes in disadvantaged and vulnerable populations.


Conclusions

In summary, we found insufficient evidence of adequate quality to conclude that interventions involving alternative models of organising or delivering antenatal care have been demonstrated to be effective in reducing infant mortality or PTB in socially disadvantaged or vulnerable populations compared with standard models of antenatal care. A small number of the interventions reviewed here were considered 'promising' in terms of their effect on PTB in socially disadvantaged or vulnerable populations, but the effects, if any, are likely to be modest and further robust evaluation would be required before routine adoption of these interventions could be recommended.


List of abbreviations

OECD: Organisation for Economic Co-operation and Development; WIC: Special Supplemental Nutrition Program for Women, Infants and Children


Competing interests

The authors declare that they have no competing interests.


Authors' contributions

JH, JK, PB and RG were involved in study concept and design; JH and RG developed the search strategy; JH ran the searches, carried out screening, quality appraisal and data extraction with the assistance of LO and other members of the review team (see acknowledgements); JK and RG assisted with full-text screening and quality appraisal in cases of disagreement between reviewers; JH wrote the study report and drafted the manuscript; all authors were involved in review and approval of the final manuscript.


Pre-publication history

The pre-publication history for this paper can be accessed here:

http://www.biomedcentral.com/1471-2393/11/13/prepub


Supplementary Material Additional file 1

Details of the search strategies used in the review.


Click here for additional data file (1471-2393-11-13-S1.PDF)

Additional file 2

Reasons for exclusion during screening.


Click here for additional data file (1471-2393-11-13-S2.PDF)

Additional file 3

Study quality: results of GATE assessment.


Click here for additional data file (1471-2393-11-13-S3.PDF)

Additional file 4

Overview of the intervention characteristics, by target population.


Click here for additional data file (1471-2393-11-13-S4.PDF)


Acknowledgements

This is an independent report from a study which is funded by the Policy Research Programme in the Department of Health. The views expressed are not necessarily those of the Department.

We thank Jenny Caird and Irene Kwan who assisted with screening, data extraction and quality appraisal and Jane Henderson who assisted with screening.


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Figures

[Figure ID: F1]
Figure 1 

Screening and study inclusion flow chart.



Tables
[TableWrap ID: T1] Table 1 

Criteria for including studies in the review


Inclusion criteria
Study design Experimental or observational effectiveness evaluation, with control or comparator group
Population Socially disadvantaged or vulnerable populations*
Other specified at risk population: teenagers, obese pregnant women, substance users, alcohol misusers, women who are HIV positive
Intervention Intervention involving the organisation and/or delivery of:
 • comprehensive antenatal care
 • components of antenatal care provided in the context of normal antenatal care
and/or
 • Stand alone interventions involving the provision of health or social care to pregnant women delivered as an adjunct to normal antenatal care
Exclusions:
 • stand-alone interventions targeting pregnant women not delivered and/or evaluated in conjunction with standard antenatal care
 • clinical interventions, unless evaluated in the context of a broader package of antenatal care
 • interventions with a focus on labour/birth or the periconceptional period
 • interventions involving only opiate substitution
Comparator Standard antenatal care or a specified alternative model of antenatal care
Outcome  • Preterm birth (or "preterm labour") expressed as the number/proportion of women delivering before 37 weeks gestation (or some other cut-off point <37 weeks)
 • Any measure of neonatal/infant mortality, but excluding perinatal mortality
 • Birth prevalence of congenital anomalies
 • SIDS/SUDI
Type of publication Journal articles reporting primary research in English and non-English language journal articles with an English Language abstract
Geographical area OECD member countries, excluding Mexico and Turkey**
Time period Published 1990 onwards

*Including: women living in deprived areas, disadvantaged minority ethnic/racial groups, women in prison, travellers, homeless women, asylum seekers and refugees, recently arrived migrants/other immigrant groups, victims of abuse, women with mental illness/mental health problems, women with learning disabilities, sex workers.

**High-income countries with low infant mortality.


[TableWrap ID: T2] Table 2 

Characteristics of the included primary studies


Number (%) of studies
Year of publication
1990-1994 8 (22)
1995-1999 9 (25)
2000-2004 15 (42)
2005-2008 (part year) 4 (11)
Country
USA 26 (72)
Australia 4 (11)
U.K. 4 (11)
Canada 1 (3)
Greece 1 (3)
Study design
RCT-individually randomized 7 (19)
RCT-cluster randomized 2 (6)
Retrospective cohort study 12 (33)
Prospective cohort study 6 (17)
Cohort study (unspecified) 2 (6)
Mixed retrospective/prospective cohort study 1 (3)
Before and after study 6 (17)
Outcomes reported*
PTB/preterm labour 32 (89)
Infant mortality 5 (14)
Neonatal mortality 6 (17)
Congenital anomalies 6 (17)

* Not mutually exclusive


[TableWrap ID: T3] Table 3 

Studies evaluating comprehensive antenatal care programmes


Study/
Country
Setting Target
population
Study
design
Intervention
a) Programmes targeting socioeconomically disadvantaged women without specific clinical risk factors for PTB/LBW
Group antenatal care
Ickovics, 2003/
USA






Three public antenatal
clinics in Atlanta,
Georgia and New Haven,
serving predominantly
low-income, uninsured
(Medicaid or self-
pay) minority women.

Women without severe
medical or psychiatric
problems who entered
antenatal care at
one the three study
clinics at 24 or less
weeks'gestation between
August 1999 and March
2002.
Prospective
cohort study






Groups of 8-10 women with similar estimated due date receive the majority
of their antenatal care in a communal/group setting. Groups meet
periodically (typically fortnightly) with each group led by a trained
practitioner. The group care model emphasizes education, skills- building,
peer support and personal empowerment.



Ickovics, 2007/
USA










Publicly funded obstetric
clinics in two university
affiliated hospitals in
Connecticut and Georgia.








Women aged less
than 25 entering
antenatal care at the
two study sites
between September 2001
and December 2004; less
than 24 weeks' gestation;
no "high-risk" medical
problems (e.g. HIV);
consenting to
randomization. Multiple
gestations excluded in
PTB `analysis.
Randomised
controlled
Trial









See above (Ickovics, 2003).











Temple Infant and Parent Support Services (TIPPS) programme
Reece, 2002/
USA




Community and hospital
based maternity services
in North Philadelphia,
Pennsylvania.


Medically indigent women
who enrolled in the
intensive maternity care
programme(TIPPS) or
who enrolled in usual
antenatal care at
the study hospital
Prospective
cohort
study



A comprehensive multidisciplinary service which includes complete antenatal
and delivery care, well baby care, health education, nutritionist care and
counselling and psychosocial care and a range of components to increase
uptake and remove barriers to care, e.g. outreach teams interface with
community-based organizations to identify pregnant women who are not
receiving antenatal care.
Tennessee Medicaid Managed Care programme (TennCare)
Conover, 2001/
USA



Antenatal services for
Medicaid eligible women
in Tennessee and North
Carolina.

Women resident in the
two study areas delivering
a singleton live births
in 1993 and 1995. Study
populations NOT restricted
to Medicaid eligible women
Before and
after study
with an
adjacent US
state as a
control group.
A public medical assistance programme which delivers antenatal care
through a 'managed care' model.



b) Programmes providing enhanced antenatal care to socioeconomically disadvantaged women with additional clinical risk factors for PTB/LBW
West Los Angeles Preterm Prevention Project
Hobel, 1994/
USA














Public antenatal clinics
in West Los Angeles,
California.













Women with a
first antenatal
clinic visit at
one of the study
sites between 1983
and 1986 and with
a completed risk
assessment indicating
high-risk of PTB.
Multiple pregnancies,
those that aborted
at <20 weeks
gestation and those
that resulted in
stillbirth or major
congenital anomaly
excluded.
Cluster
randomised
controlled
trial












Clinic-based enhanced antenatal care for high risk women. Eligible women
attending the clinics providing the programme receive more frequent
visits (every two weeks), pre-term prevention education (three classes
covering "identification of pre-term labour, steps to take if signs or
symptoms occurred, prevention strategies and what to expect at the
hospital") as well as psychosocial and nutritional screening and crisis intervention.










Alabama augmented antenatal care programme for high risk women
Klerman, 2001/
USA






















Public health care
system, Jefferson
County, Alabama.





















African-American, Medicaid-
eligible pregnant women
seeking antenatal care
from the Jefferson County
Department of Health
between March 1994 and
June 1996; women at
least 16 yrs old,
less than 26 weeks'
gestation, with a
score of 10 or higher
on a risk
assessment scale (medical
and social factors,
including prior PTB,
low pre-pregnancy
weight, no car for
transportation). Women
with alcoholism,
substance abuse, asthma,
cancer, diabetes,
epilepsy, high blood
pressure, sickle
cell disease or HIV/AIDS
were excluded.
Randomised
controlled
Trial





















Higher-risk women receive augmented care at a specially created Mother
and Family Specialty Center. The programme focuses on informing
women about their risk conditions and about what behaviour might
improve their pregnancy. The programme includes elements covering smoking
cessation,weight gain and vitamin-mineral supplementation and amelioration
of psychosocial stress/isolation. Other features include group sessions,
regular standing appointments, evening hours where needed, appointment
reminders, transportation, and on-site childcare.
















c) Programmes targeting other vulnerable/at risk groups
New York Prenatal Care Assistance Program (PCAP)
Newschaffer,
1998/USA







New York State
Medicaid
antenatal clinics.






HIV infected, drug
abusing, Medicaid claimants
who delivered a singleton
between January 1993 and
September 1994.




Retrospective
cohort
Study






The programme provides enhanced antenatal care to low income women
through a network of accredited hospital clinics. The clinics receive
financial incentives to providers to improve basic elements of management
and coordination of antenatal care. PCAP accredited clinics must: provide
patient outreach to facilitate timely prenatal care; meet frequency and
content of care standards set by the American College of Obstetricians
and Gynaecologists; conduct comprehensive risk assessment for adverse
outcomes; develop prenatal care plans; and provide nutritional services,
health education, psychological assessment and HIV related services involving
testing, counselling and management referrals.
Turner,
2000/USA




USA.
Public antenatal care
services, New York,
New York State


HIV-infected, New
York State Medicaid
enrolled women
delivering a live-
born singleton
infant between January
1993 and October 1995
Retrospective
cohort
Study



See above (Newschaffer, 1998)






[TableWrap ID: T4] Table 4 

Studies evaluating programmes provided as an adjunct to comprehensive antenatal care


Study/
Country
Setting Target
population
Study
design
Intervention
a) Interventions aimed at socioeconomically disadvantaged women
Home visiting
Kafatos, 1991/Greece









Rural primary health
care clinics in
Florina, a
socioeconomically
disadvantaged rural
region in Northern
Greece.



Women living in a
socioeconomically
disadvantaged
rural area






Cluster
randomised
controlled
trial






An outreach health education/counselling service provided by nurses
attached to rural primary health clinics. Women receive regular
(fortnightly) nurse home visits with an emphasis on nutritional
counseling covering food sources and the methods for selecting a
balanced diet; instruction in practical techniques to improve the
quality of the woman's diet including selection of foods with a high
nutrient value and preparation/preservation techniques to reduce the
loss of nutrients). Other themes covered during pregnancy included
general hygiene, preparation for delivery, breastfeeding and care of
the newborn. Home visits continued after delivery until the infant
was 12 months old; these visits focused on infant health topics.
Kitzman, 1997/USA







Public system of
obstetric care,
Memphis,
Tennessee.




Predominantly African-
American, low-income
women with multiple
socio-demographic risk
factors (unmarried,
unemployed and/or less
than 12 years education)

Randomised
controlled
trial





A programme based on the 'Elmira'/Family Nurse Partnership model.
The antenatal aspect of the interventions (which also includes
post natal home visits) involves an average of 7 home visits
focusing on improving health-related behaviour (nutrition,
smoking, alcohol and illegal drug use). Women are also taught
to recognize the signs and symptoms of pregnancy complications
and to act appropriately if these occur; and attention is paid
to compliance with treatment and to urinary tract infections
(UTIs) and sexually transmitted diseases (STDs).
Maternity care co-ordination
Buescher,
1991/USA




Services for Medicaid
eligible women, North
Carolina.



Low-income women





Retrospective
cohort
study



The care coordinators help Medicaid-eligible women receive services
and also provide to provide social and emotional support. The
programme includes outreach, to help women apply for Medicaid,
assessment (psychosocial, nutritional, medical, educational and
financial), service planning (development of an individualized plan
and provision of assistance to access services), coordination and
referral, follow up and monitoring and education and counselling.
b) Interventions aimed at or evaluated in socioeconomically disadvantaged women with additional risk factors for PTB/LBW
Home visiting/telephone support
Bryce,
1991/Australia








Three public hospital
antenatal clinics in
Perth and the offices
of 87 obstetricians
and general
practitioners in
western Australia.



Women with a prior PTB or
other specified risk
factors for adverse
pregnancy outcome.
Intervention not
restricted to
socioeconomically
disadvantaged women but
stratified analysis of
intervention effect by
social class reported
Randomised
controlled
trial







Higher-risk women receive home visits from midwives at roughly
4-6 weekly intervals (more frequently if requested by the woman)
with intervening telephone calls. The midwives provide expressive
support ("empathy, understanding, acceptance, ...") and are
instructed to provide instrumental support ("information, advice
and material aid") only on request. Physical antenatal care is
provided only in an emergency.



Moore, 1998/USA







Public health clinic,
Winston-Salem,
North Carolina





Low-income African-
American women and
low-income white
women with
additional risk
factors for PTB


Randomised
controlled
trial





Higher-risk women receive a booklet and additional instruction about
the signs and symptoms of preterm labour followed by three scheduled
nurse phone calls per week. Each call includes an assessment of health
status ("perception of uterine contractions and other pregnancy
changes, color of urine as an assessment of hydration, number of
meals eaten, number of cigarettes smoked, alcohol and drug use, and
ingestion of a prenatal vitamin capsule on the previous day");
recommendations based on the assessment; and a discussion of any
additional issues important to the mother
Oakley 1990/UK





Four hospital
antenatal clinics




Disadvantaged,
predominantly
'working class'
women with a prior
LBW birth.

Randomised
controlled
trial



A structured social support intervention consisting of a minimum of
three antenatal home visits at 14, 20 and 28 weeks, plus two
telephone contacts. Midwives engage in a semi-structured, open
ended discussion with mothers on topics of the mother's choice;
the midwives provide advice or information only if requested and
do not provide clinical care (but may refer a mother for care if
required)
c) Interventions evaluated in other vulnerable/at risk groups
Higgins Nutrition Intervention Program
Dubois,
1997/Canada




Subjects recruited
from 15 Montreal
area hospitals but
location/setting
of the Montreal
Diet Dispensary
unclear.
Pregnant adolescents





Retrospective
cohort
study



A nutritional programme delivered by trained dieticians as an adjunct
to routine antenatal care. The programme has four elements:
assessment of risks for the pregnancy; determination of an
individualized "dietary prescription"; teaching of food consumption
patterns that meet the individual's requirements while respecting
pre-existing food habits; and follow-up and supervision by the same
dietician at 2-week intervals.

[TableWrap ID: T5] Table 5 

Effectiveness of comprehensive antenatal care programmes


Study Study groups/sample size Effectiveness Evidence of effectiveness
Authors' conclusion/reviewer assessment

PTB outcome Neonatal/infant mortality
outcome
PTB Neonatal/
infant mortality
a) Programmes targeting socioeconomically disadvantaged women without specific clinical risk factors for PTB/LBW
Group antenatal care
Ickovics,
2003












229 antenatal care
attendees who
volunteered to
receive group
antenatal care vs.
229 antenatal care
attendees selected
from the women who
did not volunteer
to receive group
antenatal care,
matched on age,
race/ ethnicity,
parity and date
of delivery.
Unadjusted % PTB
(<37 weeks):

9.2% vs. 9.6%, p = 0.83.

Unadjusted % early PTB
(<33 weeks):

0.9% vs. 3.1%

Unadjusted % late PTB
(33-36.9 weeks):

8.3% vs. 6.5%
Neonatal deaths, n (%):

0 (0%) vs. 3 (1.3%)











Possibly/No













No/No













Ickovics,
2007








625 women randomised to
group antenatal care vs.
370 women randomised to
individual antenatal care.






Adjusted % PTB
(<37 weeks):

9.8% vs. 13.8%,
p = .045

Adjusted odds ratio
(95% CI) for PTB:

0.67 (0.44-0.98)
N/A









Yes/Yes









N/A









Temple Infant and Parent Support Services (TIPPS) programme
Reece,
2002






380 women enrolled in the
Temple Infant and Parent
Support Services (TIPPS)
vs. 437 women (not
randomised) receiving
usual care (matched for
age, parity, ethnicity,
health insurance and
smoking)
% PTB* (<37 weeks):

4.3% vs. 12.0%,
p < 0.005




N/A







Yes/Possibly







N/A







Tennessee Medicaid Managed Care programme (TennCare)
Conover,
2001
Before and after study with an adjacent
geographical area as a control
group.
Adjusted Odds Ratio (95% CI)
for PTB (<37 weeks):
Adjusted Odds Ratios (95% CI)
for neonatal death
(<28 days):
No conclusion
stated/No
No/No

IB = Intervention area,
'before'
IA = Intervention area,
'after'
CB = Comparator area,
'before'
CA = Comparator area,
'after'

TN = Tennessee
NC = North Carolina

Sample size (births):
IB: 69329
IA:70045
CB: 94012
CA: 94910

Not randomised.

IB vs. CB: 0.764 (0.74-0.79)

IA vs. CA: 0.796 (0.77-0.82)

Ratio (IA vs. CA)/(CB vs. CA):
1.042 (1.00-1.09)














IB vs. CB: 0.862
(0.74-1.00)

IA vs. CA: 1.012
(0.87-1.18)

Ratio (IA vs. CA)/
(IB vs. CB):
1.174 (0.95-1.46)

Adjusted Odds Ratios (95% CI)
for infant death
(<1 year):
IB vs. CB (TN vs. NC, 'before'):
0.990 (0.88-1.11)

IA vs. CA (TN vs. NC, 'after'):
1.146 (1.02-1.29)

Ratio(IA vs. CA)/(IB vs. CB):
1.158 (0.98-1.37)
b) Programmes providing enhanced antenatal care to socioeconomically disadvantaged women with additional clinical risk factors for PTB/LBW
West Los Angeles Preterm Prevention Project
Hobel,
1994










1774 high-risk women
attending a clinic
randomised to provide
the PTB prevention
programme vs. 880
high-risk women
attending a clinic
randomised to usual
care (clinics unaware
of women's risk scores).


Unadjusted % PTB (<37 weeks):

7.4% vs. 9.1% (C1), p = 0.063.

Adjusted*Odds Ratio(95% CI)
for PTB(<37 weeks):

0.78 (0.58-1.04). One-sided
test for treatment effect:
p = .045.

* Adjusted for number of
high risk problems.
N/A











Yes/Possibly











N/A











Alabama augmented antenatal care programme for high risk women
Klerman,
2001

318 women randomised to
receive augmented care
vs. 301 women randomised
to usual care
Unadjusted % PTB (undefined):

10.6% vs. 14.0%, p = 0.22
N/A


No/No


N/A


c) Programmes targeting other vulnerable/at risk groups
New York Prenatal Care Assistance Program (PCAP)
Newschaffer,
1998









240 eligible women (HIV
infected, drug abusing)
who received antenatal
care at a PCAP
participating clinic vs.
113 eligible women who
received antenatal care
at a non PCAP-
participating clinic.

Not randomised
Unadjusted % PTB (<37 weeks):

13% vs. 22.6%, p = .001

Adjusted* Odds Ratio (95% CI)
for PTB (<37 weeks):

0.57 (0.34-0.97)

*Adjusted for maternal characteristics.
N/A










Yes/Possibly










N/A










Turner,
2000













1298 eligible women
(HIV infected) who
received antenatal
care from a PCAP-
participating clinic
vs. 425 eligible
women who received
antenatal care from
a non PCAP-
participating clinic.

Not randomised



Adjusted Odds Ratio (95% CI)
for PTB (<37 weeks):

0.53 (0.40-0.70)*

*Adjusted for maternal
characteristics

Additional adjustment for
health care and social
service use during pregnancy,
illicit drug use, and for
adequacy of antenatal care
attenuates the effect, but
effects remain statistically
significant.
N/A














Yes/Possibly














N/A















[TableWrap ID: T6] Table 6 

Effectiveness of interventions provided as an adjunct to comprehensive antenatal care


Study Study groups/sample size Effectiveness Evidence of effectiveness:
authors' conclusion/reviewer assessment

PTB outcome Neonatal/infant mortality
outcome
PTB Neonatal/
infant mortality
a) Interventions aimed at socioeconomically disadvantaged women
Home visiting/telephone support
Kafatos,
1991






Florina intervention
programme. 296 women
attending one of the
clinics cluster randomised
to provide the interventions
vs. 263 women attending
one of the clinics
randomised to provide
normal care.
Unadjusted % PTB
(<37 weeks):

3.7% vs. 8.3%,
p < 0.04



Neonatal deaths, n (%)
(<27 days):

6 (2.1%) vs. 5 (2.0%)




Yes/Possibly







No/No







Kitzman,
1997




















518 women randomised to
receive intensive nurse
home-visitation services
during pregnancy vs.
681 women randomised to
receive normal care
during pregnancy.















Unadjusted % PTB
(<37 weeks):

11% vs. 13%

Unadjusted %
spontaneous PTB
(<37 weeks):

8% vs. 9%

Adjusted Odds Ratio
(95% CI) for PTB
(<37 weeks):

0.8 (0.6-1.2)

Adjusted Odds Ratio
(95% CI) for
spontaneous PTB
(<37 weeks):

0.8 (0.5-1.3)
N/A





















No/No





















N/A





















Maternity care coordination
Buescher,
1991







15,526 women who received maternity
care coordination vs. 34,463 women
who did not receive
maternity care coordination.

Not randomised


N/A








Unadjusted infant deaths
per 1000 live births:

9.9 vs. 12.2, p = 0.02

Adjusted Odds Ratio
(95% CI) for
infant death:

1.20 (0.98-1.47)
N/A








Possibly/
Possibly







b) Interventions aimed at or evaluated in socioeconomically disadvantaged women with additional risk factors for PTB/LBW
Home visits/telephone support
Bryce,
1991













981 women randomised to
receive additional
antenatal social
support vs. 986 women
randomised to receive
standard antenatal care.









Stratified Odds Ratio
(95% CI) for PTB
(stratified by
social class)

0.84 (0.65-1.09)

Odds Ratios by
social class:
Professional: 0.59
(0.36-0.96)
Clerical: 1.00
(0.64-1.56)
Manual: 0.96
(0.59-1.56)
Neonatal deaths before
hospital discharge:

1.4% vs. 0.6%

Postneonatal deaths
before hospital
discharge:

0% vs. 0.2%





No/No














No conclusion
stated/No













Moore,
1998
































775 women randomised to
receive the nurse
telephone intervention
vs. 779 women randomised
to receive usual care.





























% PTB (<37 weeks)

9.7% vs. 11.0%;

Relative Risk (RR)
(95% CI):
0.87 (0.62-1.22),
p = 0.415

Stratified analysis:
Black women, aged
< = 18 years:
11.0% vs. 7.9%
RR: 1.39 (0.72,2.67),
p = 0.039

Black women, aged
> = 19 years:
8.7% vs. 15.4%
RR: 0.56 (0.38-0.84),
p = 0.004

White or
other women,
aged < = 18 years:
7.8% vs. 4.1%
RR: 1.92 (0.61-6.02),
p = 0.255

White or
other women,
aged > = 19 years:
19.6% vs. 6.6%
RR: 2.99; (0.98-9.09),
p = 0.041
N/A

































No*/No
*Authors conclude
intervention effective
in subgroup of black
women aged ≥19





























N/A

































Oakley
1990











255 women randomised
to receive social
support plus usual
care vs. 254 women
randomised to
receive usual care







% PTB (<37 weeks):

18% vs. 19%

% by gestational age:

<28 weeks:
2% vs. 1%
28-32 weeks:
3% vs. 4%
33-36 weeks:
13% vs. 14%
37+ weeks:
82% vs. 81%
Neonatal deaths (%):

1% vs. 1%










No conclusion
stated/No











No conclusion
stated/No











c) Interventions evaluated in other vulnerable/at risk groups
Higgins Nutrition Intervention Program
Dubois,
1997






























1203 adolescents who
participated in the Higgins
Nutrition Intervention
during pregnancy vs. 1203
adolescents (matched on
site, year and age) who
did not receive the
intervention.

Not randomized.






















Unadjusted % PTB
(<37 weeks):

8.2% vs. 12.8%

Unadjusted %
very preterm
(<34 weeks):

2.3% vs. 5.1%

Adjusted Odds Ratio
(95% CI) for
PTB (<37 weeks):

0.59 (0.45 - 0.78),
p < = 0.001

Adjusted Odds Ratio
(95% CI)
for very preterm birth
(<34 weeks)

0.53 (0.35 - 0.81),
p < = 0.001

Odds ratios also
reported for
subsamples-pregravid
weight <50 kg;
pregravid weight
50 kg or more;
13-17 yrs; 18-19 yrs.
N/A































Yes/Possibly































N/A

































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