Clinical, psychosocial, and economic effects of antenatal day care for three medical complications of pregnancy: a randomised controlled trial of 395 women. Assessment of the effect of psychosocial support during childbirth in Ibadan, south-west Nigeria: a randomised controlled trial. The value of a pilot study in breast-feeding research. Group prenatal care and perinatal outcomes: a randomized controlled trial. A pilot study to assess the viability of a randomised controlled trial of methods of supplementary feeding of breast-fed pre-term babies. A randomised controlled trial comparing birthing centre care with delivery suite care in Adelaide, Australia. A randomized, controlled trial of nurse home visiting to vulnerable families with newborns. Tailoring systematic reviews to meet critical priorities in maternal health in the intrapartum period. Informing resource-poor populations and the delivery of entitled health and social services in rural India: a cluster randomized controlled trial.
Day care is increasingly being used for complications of pregnancy, but there is little published evidence on its efficacy. We assessed the clinical, psychosocial, and economic effects of day care for three pregnancy complications in a randomised trial of day care versus standard care on an antenatal ward.
                395 women were randomly assigned day (263) or ward (132) care in a ratio of two to one, stratified for major diagnostic categories (non-proteinuric hypertension, proteinuric hypertension, and preterm premature rupture of membranes). The research hypothesis was that for these disorders, as an alternative to admission, antenatal day care will reduce specified interventions and investigations, result in no differences in clinical outcome, lead to greater satisfaction and psychological wellbeing, and be more cost-effective. Data were collected through case-note review, self-report questionnaires (response rates 81.0% or higher) and via the hospital's financial system. Analysis was by intention to treat.
                All participants were included in the analyses. There were no differences between the groups in antenatal tests or investigations or intrapartum interventions. The total duration of antenatal care episodes was shorter in the day-care group than in the ward group (median 17 [IQR 5-9] vs 57 [35-123] h; p=0.001). Overall stay was also significantly shorter in the day-care group (mean 7.22 [SE 0.31] vs 8.53 [0.44]; p=0.014). The median number of care episodes was three (range one to 14) in the day-care group and two (one to nine) in the ward group (p=0.01). There were no statistically or clinically significant differences in maternal or perinatal outcomes. The day-care group reported greater satisfaction, with no evidence of unintended psychosocial sequelae. There was no significant difference in either average cost per patient or average cost per day of care.
                Since clinical outcomes and costs are similar, adoption by maternity services of a policy providing specified women with the choice between admission and day-unit care seems appropriate. To assess the effect of psychosocial support on labour outcomes.
                A randomised control trial conducted at the University College Hospital Ibadan, Nigeria, from November 2006 to 30 March 2007. Women with anticipated vaginal delivery were recruited and randomised at the antenatal clinic. The experimental group had companionship in addition to routine care throughout labour until two hours after delivery, while the controls had only routine care. The primary outcome measure was caesarean section rate. Others included duration of active phase, pain score, time of breast-feeding initiation and description of labour experience. Multivariable analyses were used to adjust for potential confounders. The level of statistical significance was set at 5%.
                Of the 632 recruited, 585 were eventually studied: 293 and 292 were in experimental and control groups, respectively. Husbands constituted about two-thirds of the companions. Women in the control group were about five times more likely to deliver by caesarean section (95% confidence interval (CI) 1.98-12.05), had significantly longer duration of active phase (P < 0.001), higher pain scores (P = 0.011) and longer interval between delivery and initiation of breast-feeding (P < 0.001). However, those in experimental group had a more satisfying labour experience (odds ratio 3.3 95% CI 2.15-5.04).
                Women with companionship had better labour outcomes compared to those without. It is desirable to adopt this practice in our health-care settings as an alternative strategy to provide comparable quality services to would-be mothers in labour. To test the integrity of a protocol for a randomised controlled trial (RCT) to examine the effectiveness of skin-to-skin care compared to routine care on the initiation and duration of breast feeding and to provide data to be used in the power calculation for a proposed trial.
                Randomised pilot study.
                Warrington Hospital, Cheshire, UK.
                Women at 36 weeks' gestation with healthy singleton pregnancies, who intended to breast feed, who had 'booked' for care at Warrington Hospital and had given informed consent to participate. Twenty-eight women were randomised in the pilot study.
                Women were randomly allocated to receive either routine or skin-to-skin care following birth. The first breast feed was assessed using the Breast-feeding Assessment Tool (BAT). Mothers were followed up at discharge from hospital and again at four months to provide details of duration of breast feeding.
                66 women were approached to participate in the trial and 44 consented (67% consent rate). Twenty-eight women were randomised in the study and 26 breast feeds were observed (93%). The pilot study identified procedural changes that were required in the design of the main study, provided an estimate of recruitment rates and confirmed the previously calculated sample size.
                The pilot study demonstrated that a large RCT of skin-to-skin versus routine care was feasible. This is an example of how a pilot study has the ability to identify unforeseen challenges in the conduct of the trial as well as allowing necessary changes to be made to the design that will increase the quality of the subsequent research. To determine whether group prenatal care improves pregnancy outcomes, psychosocial function, and patient satisfaction and to examine potential cost differences.
                A multisite randomized controlled trial was conducted at two university-affiliated hospital prenatal clinics. Pregnant women aged 14-25 years (n=1,047) were randomly assigned to either standard or group care. Women with medical conditions requiring individualized care were excluded from randomization. Group participants received care in a group setting with women having the same expected delivery month. Timing and content of visits followed obstetric guidelines from week 18 through delivery. Each 2-hour prenatal care session included physical assessment, education and skills building, and support through facilitated group discussion. Structured interviews were conducted at study entry, during the third trimester, and postpartum.
                Mean age of participants was 20.4 years; 80% were African American. Using intent-to-treat analyses, women assigned to group care were significantly less likely to have preterm births compared with those in standard care: 9.8% compared with 13.8%, with no differences in age, parity, education, or income between study conditions. This is equivalent to a risk reduction of 33% (odds ratio 0.67, 95% confidence interval 0.44-0.99, P=.045), or 40 per 1,000 births. Effects were strengthened for African-American women: 10.0% compared with 15.8% (odds ratio 0.59, 95% confidence interval 0.38-0.92, P=.02). Women in group sessions were less likely to have suboptimal prenatal care (P<.01), had significantly better prenatal knowledge (P<.001), felt more ready for labor and delivery (P<.001), and had greater satisfaction with care (P<.001). Breastfeeding initiation was higher in group care: 66.5% compared with 54.6%, P<.001. There were no differences in birth weight nor in costs associated with prenatal care or delivery.
                Group prenatal care resulted in equal or improved perinatal outcomes at no added cost.
                ClinicalTrials.gov, www.clinicaltrials.gov, NCT00271960
                I. to compare the impact of two methods of supplementary feeding of pre-term babies (bottle vs cup) on subsequent breast feeding and to assess the feasibility of using a randomised controlled trial (RCT) to investigate the topic.
                small scale prospective RCT. Data on breast feeding, as defined as the exclusive method of feeding, were collected. A range of relevant bio-data was also collected and their impact on breast feeding assessed.
                a special care baby unit in a District General Hospital in the UK.
                over a three-month period, all pre-term babies (32-37 weeks' gestation) who fulfilled the inclusion criteria and has been born to mothers who had expressed a pre-partum desire to breast feed, who had consented to take part, were included (n=14).
                the eligible babies were randomly allocated to supplementary feeding of breast milk, via either a cup or a bottle. Whether or not the baby was being breast fed at discharge was noted.
                the study suggested that this RCT framework is a viable method of investigating baby feeding. Because of the small-scale nature of the project, the actual database must be treated with extreme caution. No significant differences were found between the two groups in terms of breast feeding. However, the mothers reported high levels of support and also the breast-feeding rates were above the national averages. These two findings could have contributed to the non-significant results observed in this analysis.
                if the present findings could be supported by further research, then the non-significant results relating method of supplementary feeds to subsequent breast feeding could be explained by reference to three factors. Firstly, there is, in fact, no real effect of method of supplementary feeding and subsequent breast feeding; secondly, the method adopted differed from existing research and thus may be expected to produce non-corroborative results; and finally, the overall levels of breast feeding within the Unit generally were higher than the national average. The relevance of the RCT for investigating this subject is also discussed with reference to the present data set. Further experimental work to develop these ideas and to identify causal links is required.
                Copyright 2001 Harcourt Publishers Ltd. Birthing centre care offers women with a low risk of complication in pregnancy an alternative to conventional care for the birthing of their baby. It is important these two forms of care are appropriately assessed. A randomised controlled trial comparing the newly opened birthing centre with the established conventional delivery suite was conducted at the then Queen Victoria Hospital, Adelaide, South Australia. The outcomes measured included maternal satisfaction, costs and clinical outcomes both for mother and baby which related to the need for Caesarean section, episiotomy or tear rate and method of feeding. Two hundred and one women attending the hospital's antenatal clinic were randomly allocated to either birthing centre or delivery suite care. One hundred women were allocated to the birthing centre. No differences were found in either group related to clinical outcomes or costs. The only difference in maternal satisfaction was the choice women made for their next birth. More women in the birthing centre group felt they were encouraged to breastfeed immediately after birth. While the numbers in this study were too small to detect any but large differences in outcome, birthing centre care should remain an option for women and further studies undertaken with larger numbers. This project aimed to evaluate the impact of a home visiting programme that targeted families where the child, for environmental reasons, was at great risk of poor health and developmental outcomes.
                Women in the immediate postpartum period were recruited to a randomized double-blind controlled trial on the basis of self-reported vulnerability factors and were randomly assigned to receive either a structured programme of nurse home visiting, supported by a social worker and paediatrician (n = 90), or assigned to a comparison group receiving standard community child health services (n = 91). Parenting stress and maternal depression were measured at enrollment and at 6 weeks. Preventive health behaviour, service satisfaction and home environment outcomes were tested at 6 weeks, as were child health outcomes.
                At six weeks, women receiving the home-based programme had significant reductions in postnatal depression screening scores as well as improvements in their experience of the parental role and improvement in the ability to maintain their own identity. Maternal-infant interactions were more likely to be positive, with significantly higher (better) scores in aspects of the home environment related to optimal development in children, particularly maternal-infant secure attachment. Intervention group mothers were significantly more satisfied with the community child health service.
                This form of intervention for families is effective in promoting secure maternal-infant attachment, preventing maternal mood disorder and is welcomed by the families receiving it. These findings may predict long-term benefits for the healthy development of children otherwise at risk of a range of poor health and development outcomes. Health care practitioners and researchers commonly call for greater reliance on evidence as a means to achieve improvement in quality of care. Systematic reviews provide a means to accelerate the use of evidence-based clinical interventions and public health practices. The extent to which these time- and resource-intensive systematic reviews currently address critical maternal health priorities in the intrapartum period is unclear. This analysis summarises key maternal health and research priorities, maps these priorities to existing reviews, identifies gaps in the literature that can be addressed with systematic reviews, and highlights key methodological concerns in conducting systematic reviews. The analysis draws on published data on maternal morbidities and an overview of 108 systematic reviews in Medline in the past 5 years using the MeSH terms 'Delivery, Obstetric,' to draw the links between health priorities, research priorities, existing evidence and missing evidence. Key causes of morbidity during labour and delivery in the United States include haemorrhage, pre-eclampsia and eclampsia, obstetric trauma and infection. Analyses of maternal morbidity and mortality suggest that key concerns include racial and ethnic disparities in health outcomes and the prevention of adverse events. Systematic reviews, however, generally tend to focus on the reduction of harms associated with interventions, are frequently limited to randomised designs, and do not address issues of health disparities. The results suggest that advances in evidence-based care in maternal health require that systematic reviews address issues of prevention of adverse events, include a larger variety of study designs when necessary and pay closer attention to health disparities. A lack of awareness about entitled health and social services may contribute to poor delivery of such services in developing countries, especially among individuals of low socioeconomic status.
                To determine the impact of informing resource-poor rural populations about entitled services.
                Community-based, cluster randomized controlled trial conducted from May 2004 to May 2005 in 105 randomly selected village clusters in Uttar Pradesh state in India. Households (548 intervention and 497 control) were selected by a systematic sampling design, including both low-caste and mid- to high-caste households.
                Four to 6 public meetings were held in each intervention village cluster to disseminate information on entitled health services, entitled education services, and village governance requirements. No intervention took place in control village clusters.
                Visits by nurse midwife; prenatal examinations, tetanus vaccinations, and prenatal supplements received by pregnant women; vaccinations received by infants; excess school fees charged; occurrence of village council meetings; and development work in villages.
                At baseline, there were no significant differences in self-reported delivery of health and social services. After 1 year, intervention villagers reported better delivery of several services compared with control villagers: in a multivariate analysis, 30% more prenatal examinations (95% confidence interval [CI], 17%-43%; P < .001), 27% more tetanus vaccinations (95% CI, 12%-41%; P < .001), 24% more prenatal supplements (95% CI, 8%-39%; P = .003), 25% more infant vaccinations (95% CI, 8%-42%; P = .004), and decreased excess school fees of 8 rupees (95% CI, 4-13 rupees; P < .001). In a difference-in-differences analysis, 21% more village council meetings were reported (95% CI, 5%-36%; P = .01). There were no improvements in visits by a nurse midwife or in development work in the villages. Both low-caste and mid- to high-caste intervention households reported significant improvements in service delivery.
                Informing resource-poor rural populations in India about entitled services enhanced the delivery of health and social services among both low- and mid- to high-caste households. Interventions that emphasize educating resource-poor populations about entitled services may improve the delivery of such services.
                clinicaltrials.gov Identifier: NCT00421291.
The review included two relatively small studies that did not have sufficient statistical power to detect meaningful differences between groups. Future large and adequately powered randomised controlled trials are required to measure differences between groups for relevant pre-specified outcomes. Special attention should be given to the assessment of maternal satisfaction with care and cost analysis as they will have social and economic implications in both developed and developing countries.