Simple antenatal preparation to improve breastfeeding practice: a randomized controlled trial. Randomized controlled trials in pediatric surgery: could we do better? A pilot randomized controlled trial of a breastfeeding self-efficacy intervention with primiparous mothers. Randomised trial of educational visits to enhance use of systematic reviews in 25 obstetric units. A randomised controlled trial of empowerment training for Chinese abused pregnant women in Hong Kong. A pilot study to assess the viability of a randomised controlled trial of methods of supplementary feeding of breast-fed pre-term babies. Clinical, psychosocial, and economic effects of antenatal day care for three medical complications of pregnancy: a randomised controlled trial of 395 women. A randomised controlled trial comparing two schedules of antenatal visits: the antenatal care project. Brief antenatal cognitive behaviour therapy group intervention for the prevention of postnatal depression and anxiety: a randomised controlled trial. Pragmatic randomized trial of antenatal intervention to prevent post-natal depression by reducing psychosocial risk factors. Effect of training for care providers on practice of essential newborn care in hospitals in Sri Lanka. Breastfeeding expectations versus reality: a cluster randomised controlled trial. Effectiveness of Agency for Health Care Policy and Research clinical practice guideline and patient education methods for pregnant smokers in medicaid maternity care. A behavioral intervention to improve obstetrical care.
To address the impact of simple antenatal educational interventions on breastfeeding practice.
                A randomized controlled trial was carried out in a tertiary referral center from May 2002 to December 2004. A random sample of eligible low-risk antenatal patients was recruited from clinics in the National University Hospital, Singapore. Group A received breastfeeding educational material and individual coaching from a lactation counselor. Group B received breastfeeding educational material with no counseling. Group C received routine antenatal care only.
                A total of 401 women were recruited. Mothers receiving individual counseling and educational material practiced exclusive and predominant breastfeeding more often than mothers receiving routine care alone at 3 months (odds ratio [OR] 2.6, 95% confidence interval [CI] 1.2-5.4) and 6 months (OR 2.4, 95% CI 1.0-5.7) postpartum. More mothers practiced exclusive and predominant breastfeeding at 6 months among women receiving individual counseling compared with women exposed to educational material alone (OR 2.5, 95% CI 1.0-6.3).
                Where breastfeeding practices are suboptimal, simple one-encounter antenatal education and counseling significantly improve breastfeeding practice up to 3 months after delivery. Provision of printed or audiovisual educational material is not enough. Health care workers should make every effort to have one face-to-face encounter to discuss breastfeeding with expectant mothers before they deliver.
                (www.ClinicalTrials.gov), NCT002770192
                I. Randomized controlled trials (RCTs) are accepted as the gold standard for assessing the effectiveness of clinical interventions but are rarely reported in pediatric surgery. Have RCTs submitted to the British Association of Paediatric Surgeons (BAPS) Annual Congress during the last 5 years been adequately designed and large enough to produce a valid result?
                Abstracts accepted by the Annual BAPS Congress meetings between 1996 and 2000 were examined in collaboration with a senior health services researcher. The quality of the design, methodology, statistical analysis and conclusions, and the adequacy of the sample size were assessed for all identifiable clinical RCTs.
                From 760 accepted abstracts, there were only 9 RCTs (1%) of clinical interventions. In only 4 trials was the relevant primary end-point specified at the outset of the study, and none documented the method of randomization. Only one abstract mentioned blinding with respect to the intervention or outcome measure. Sample sizes were inadequate to detect even large clinical differences. To date, only one of these RCTs has been published in an English-language, peer-reviewed journal.
                Clear guidelines exist for the conduct of RCTs, yet compliance with these standards was rarely documented in abstracts of pediatric surgical RCTs presented at BAPS. Sample sizes were inadequate. RCTs in pediatric surgery are difficult to perform, but the specialty would benefit from well-designed, carefully conducted, multicentre, clinical RCTs to advance evidence-based practice.
                Copyright 2003, Elsevier Science (USA). All rights reserved. To pilot test a newly developed breastfeeding self-efficacy intervention.
                Pilot randomized controlled trial (RCT).
                An acute care hospital located in Northwestern Ontario that is the sole provider of maternity care for the city and referral center for the region.
                One-hundred-and-fifty primiparous women intending to breastfeed their healthy, term, singleton infant.
                A standardized, individualized nursing intervention protocol was designed and administered to increase mothers' breastfeeding self-efficacy. Participants were randomly allocated to the intervention group or control group using sealed, opaque envelopes. Participants in the intervention group received three individualized, self-efficacy enhancing sessions with the researcher: two in-hospital and one by telephone. Participants in the control group received standard in-hospital and community care.
                Feasibility, compliance, and the acceptability of the breastfeeding self-efficacy intervention. Other outcomes assessed were breastfeeding self-efficacy, duration, and exclusivity.
                Findings suggest that the intervention was feasible; there was a high degree of protocol compliance, and the majority of mothers reported that the intervention was beneficial. Mothers in the intervention group had higher rates of breastfeeding self-efficacy, duration, and exclusivity at 4 and 8 weeks postpartum. However, the differences between groups were not statistically significant.
                The pilot RCT provided valuable information in examining the feasibility of the trial design and intervention.
                © 2011 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses. To evaluate the effectiveness of an educational visit to help obstetricians and midwives select and use evidence from a Cochrane database containing 600 systematic reviews.
                Randomised single blind controlled trial with obstetric units allocated to an educational visit or control group.
                25 of the 26 district general obstetric units in two former NHS regions.
                The senior obstetrician and midwife from each intervention unit participated in educational visits. Clinical practices of all staff were assessed in 4508 pregnancies.
                Single informal educational visit by a respected obstetrician including discussion of evidence based obstetrics, guidance on implementation, and donation of Cochrane database and other materials.
                Rates of perineal suturing with polyglycolic acid, ventouse delivery, prophylactic antibiotics in caesarean section, and steroids in preterm delivery, before and 9 months after visits, and concordance of guidelines with review evidence for same marker practices before and after visits.
                Rates varied greatly, but the overall baseline mean of 43% (986/2312) increased to 54% (1189/2196) 9 months later. Rates of ventouse delivery increased significantly in intervention units but not in control units; there was no difference between the two types of units in uptake of other practices. Pooling rates from all 25 units, use of antibiotics in caesarean section and use of polyglycolic acid sutures increased significantly over the period, but use of steroids in preterm delivery was unchanged. Labour ward guidelines seldom agreed with evidence at baseline; this hardly improved after visits. Educational visits cost pound860 each (at 1995 prices).
                There was considerable uptake of evidence into practice in both control and intervention units between 1994 and 1995. Our educational visits added little to this, despite the informal setting, targeting of senior staff from two disciplines, and donation of educational materials. Further work is needed to define cost effective methods to enhance the uptake of evidence from systematic reviews and to clarify leadership and roles of senior obstetric staff in implementing the evidence. To evaluate the effectiveness of an empowerment intervention in reducing intimate partner violence (IPV) and improving health status.
                Randomised controlled trial.
                Antenatal clinic in a public hospital in Hong Kong.
                One hundred and ten Chinese pregnant women with a history of abuse by their intimate partners.
                Women were randomised to the experimental or control group. Experimental group women received empowerment training specially designed for Chinese abused pregnant women while the control group women received standard care for abused women. Data were collected at study entry and six weeks postnatal.
                IPV [on the Conflict Tactics Scale (CTS)], health-related quality of life (SF-36) and postnatal depression [Edinburgh Postnatal Depression Scale (EPDS)].
                Following the training, the experimental group had significantly higher physical functioning and had significantly improved role limitation due to physical problems and emotional problems. They also reported less psychological (but not sexual) abuse, minor (but not severe) physical violence and had significantly lower postnatal depression scores. However, they reported more bodily pain.
                An empowerment intervention specially designed for Chinese abused pregnant women was effective in reducing IPV and improving the health status of the women. 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. 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 compare the clinical and psychological effectiveness of the traditional British antenatal visit schedule (traditional care) with a reduced schedule of visits (new style care) for low risk women, together with maternal and professional satisfaction with care.
                Randomised controlled trial.
                Places in south east London providing antenatal care for women receiving shared care and planning to deliver in one of three hospitals or at home.
                2794 women at low risk fulfilling the trial's inclusion criteria between June 1993 and July 1994.
                Measures of fetal and maternal morbidity, health service use, psychosocial outcomes, and maternal and professional satisfaction.
                Pregnant women allocated to new style care had fewer day admissions (0.8 v 1.0; P=0.002) and ultrasound scans (1.6 v 1.7; P=0.003) and were less often suspected of carrying fetuses that were small for gestational age (odds ratio 0.73; 95% confidence interval 0.54 to 0.99). They also had some poorer psychosocial outcomes; for example, they were more worried about fetal wellbeing antenatally and coping with the baby postnatally, and they had more negative attitudes to their babies, both in pregnancy and postnatally. These women were also more dissatisfied with the number of visits they received (odds ratio 2.50; 2.00 to 3.11).
                Patterns of antenatal care involving fewer routine visits for women at low risk may lead to reduced psychosocial effectiveness and dissatisfaction with frequency of visits. The number of antenatal day admissions and ultrasound scans performed may also be reduced. For the variables reported, the visit schedules studied are similar in their clinical effectiveness. Uncertainty remains as to the clinical effectiveness of reduced visit schedules for rare pregnancy problems. The majority of randomised controlled trials examining the effectiveness of antenatal group interventions at preventing postnatal depression in "at risk" women have used a "psychoeducational" intervention. The aim of the present study is to evaluate the effectiveness of an antenatal cognitive behavioural group intervention in a primary care setting for pregnant women identified with mild to moderate symptoms in pregnancy and/or at risk of developing depression or anxiety in the perinatal period.
                Subjects were randomised to a CBT group intervention or control condition (information booklet) and administered the EPDS and STAI at pre (Time 1) and post intervention (Time 2), and at 2 months (Time 3) and 4 months postpartum (Time 4). MINIs were administered at Times 1, 3 and 4.
                Of the 774 women approached, 277 accepted and were suitable; thus 191 were randomised to the CBT intervention and 86 to the control condition. The subsequent 52% drop-out left 89 women "completing" the CBT groups and 43 in the control group; these two groups were well matched on demographic variables. Intention to treat analyses revealed relatively low mean baseline EPDS scores (means 6.88 -8.16) with no reduction in EPDS scores in either group from Time 1 to Time 4. MINI depression criteria were fulfilled by 19% of all participants at Time 1 but there was no reduction in depression in either group; in contrast those with MINI anxiety diagnoses reduced from 28% in late pregnancy to 16% at four months postpartum in the CBT group with similar reductions in the control group. Analyses on the 132 "completers" showed significant symptomatic improvement over time for both the CBT group and control condition. Depression scores in the most symptomatic women (EPDS>12; N=19) decreased steadily by over 50% over the total time course but there were no differences in improvement between the CBT and control groups.
                A number of methodological factors may have obscured our results including a tendency to natural remission in mildly symptomatic subjects and the possibility that our control condition was therapeutic in itself.
                While a modest reduction in depression scores was noted in study "completers", both the CBT group intervention control condition were equally beneficial. The reasons for this finding include the low symptom level at baseline; the potential effectiveness of the control condition; and the brevity of the intervention. Social support theory and observational risk factor studies suggest that increased antenatal psychosocial support could prevent post-natal depression. We used empirical knowledge of risk and protective factors for post-natal depression not employed previously in order to develop and evaluate an antenatal preventive intervention.
                We conducted a pragmatic randomized controlled trial in antenatal clinics. We screened 1300 primiparous women and 400 screened positive, 69 screen-positive women were untraceable or not eligible. Of 292 women who completed baseline assessment, 209 consented to randomization, of these 190 provided outcome data 3 months post-natally. 'Preparing for Parenthood', a structured antenatal risk factor reducing intervention designed to increase social support and problem-solving skills, was compared with routine antenatal care only. We compared the percentage depressed at 3 months after childbirth using the self-completion General Health Questionnaire Depression scale and Edinburgh Post-natal Depression Scale (EPDS), and the Schedules for Clinical Assessment in Neuropsychiatry a systematic clinical interview.
                Assignment to the intervention group did not significantly impact on post-natal depression (odds ratio for GHQ-Depression 1.22 (95% CI 0.63-2.39), P = 0.55) or on risk factors for depression. Forty-five per cent of the intervention group women attended sufficient sessions to be likely to benefit from intervention if effective. Attenders benefited no more than non-attenders.
                Prevention services targeting post-natal depression should not implement antenatal support programmes on these lines until further research has demonstrated the feasibility and effectiveness of such methods. The development of novel, low cost interventions effective in reducing risk factors should be completed before further trial evaluation. To evaluate the effectiveness of a training program for care providers in improving practice of essential newborn care in obstetric units.
                Before-and-after study with an intervention and a control group.
                Five hospitals in the Puttalam district in Sri Lanka.
                Eight hundred and ninety-two mother-newborn pairs (446 before and 446 three months after).
                A 4-day training program on essential newborn care for doctors, nurses, and midwives of the obstetric units in two hospitals.
                By direct observation, practices of essential newborn care at delivery in the labor room on a subsample. By interviewing mothers, immediate skin-to-skin contact and early initiation of breastfeeding. From health records, "undesirable health events" of the newborns.
                Practices of cleanliness, thermal protection, and neonatal assessment improved significantly in the intervention group. The intervention was effective in improving skin-to-skin contact by 1.5 times and early initiation of breastfeeding by 3.4 times. Undesirable health events declined from 32 to 21 per 223 newborns in the intervention group and from 20 to 17 per 223 newborns in the control group.
                A comprehensive 4-day training program can be followed by a significant improvement in essential newborn care practices in obstetric units. To evaluate the affect of an antenatal educational breastfeeding intervention on women's breastfeeding duration.
                Cluster randomised controlled trial. Unit of randomisation: electoral ward. The primary outcome was the proportion that fulfilled their antenatal breastfeeding expectation. Secondary outcomes were the number of women breastfeeding on discharge and at four months. Data were collected using a series of questionnaires and diaries.
                Teaching hospital in North West of England.
                Women who expressed a desire to breast-feed at the start of their pregnancy.
                Women were allocated to either routine antenatal education or an additional single educational group session supervised by a lactation specialist and attended by midwives from their locality.
                The proportion of women who fulfilled their expectation of breastfeeding.
                One thousand three hundred and twelve women were randomised, with 1249 (95%) women available for analysis. There was no difference between the groups in the proportion of women who attained their expected duration of breastfeeding (OR 1.2; 95% CI 0.89-1.6; chi(2)= 1.4, df= 1, P= 0.2; mean cluster size 156, design effect 1.6). There were no differences between the groups in the uptake of breastfeeding on discharge (OR = 1.2; 95% CI 0.8-1.7; chi(2)= 1.1, df= 1, P= 0.3; mean cluster size 163, design effect = 2.0) or exclusively at four months (OR = 1.1; 95% CI 0.6-1.8; chi(2)= 0.07, df= 1, P= 0.8; mean cluster size 156, design effect 1.6).
                The provision of a single educational group session supervised by a lactation specialist, and attended by midwives and women, failed to promote the uptake of breastfeeding. Public health interventions, which encourage positive attitudes to breastfeeding within the family and wider community, should be developed and evaluated. The purposes of this study were (1) to determine the extent to which tobacco exposure assessment and new patient education methods, derived from a meta-analysis and the Agency for Health Care Policy and Research guideline recommendations, could be provided routinely by trained Medicaid maternity care staff members and (2) to document the behavioral impact of these interventions among pregnant smokers.
                After 265 pregnant smokers were assigned at their first visit to an experimental group (n = 139) or a control group (n = 126), they received standardized risk information and were advised to quit smoking. The experimental group also received evidence-based patient education methods, including the videocassette Commit to Quit During and After Pregnancy, the publication A Pregnant Woman's Guide to Quit Smoking, and a brief counseling session. Self-report and saliva cotinine assessments of tobacco exposure were performed at baseline and at the end of pregnancy.
                A significantly higher percentage of patients quit smoking in the experimental group (17.3%) than in the control group (8.8%).
                The application of principles of organizational development and quality improvement at the management and clinical practice levels and the delivery of evidence-based health education methods by trained prenatal care providers significantly increased smoking cessation rates among pregnant Medicaid recipients. Implementation of evidence-based obstetrical practices remains a significant challenge. Effective strategies to disseminate and implement such practices are needed.
                We randomly assigned 19 hospitals in Argentina and Uruguay to receive a multifaceted behavioral intervention (including selection of opinion leaders, interactive workshops, training of manual skills, one-on-one academic detailing visits with hospital birth attendants, reminders, and feedback) to develop and implement guidelines for the use of episiotomy and management of the third stage of labor or to receive no intervention. The primary outcomes were the rates of prophylactic use of oxytocin during the third stage of labor and of episiotomy. The main secondary outcomes were postpartum hemorrhage and birth attendants' readiness to change their behavior with regard to episiotomies and management of the third stage of labor. The outcomes were measured at baseline, at the end of the 18-month intervention, and 12 months after the end of the intervention.
                The rate of use of prophylactic oxytocin increased from 2.1% at baseline to 83.6% after the end of the intervention at hospitals that received the intervention and from 2.6% to 12.3% at control hospitals (P=0.01 for the difference in changes). The rate of use of episiotomy decreased from 41.1% to 29.9% at hospitals receiving the intervention but remained stable at control hospitals, with preintervention and postintervention values of 43.5% and 44.5%, respectively (P<0.001 for the difference in changes). The intervention was also associated with reductions in the rate of postpartum hemorrhage of 500 ml or more (relative rate reduction, 45%; 95% confidence interval [CI], 9 to 71) and of 1000 ml or more (relative rate reduction, 70%; 95% CI, 16 to 78). Birth attendants' readiness to change also increased in the hospitals receiving the intervention. The effects on the use of episiotomy and prophylactic oxytocin were sustained 12 months after the end of the intervention.
                A multifaceted behavioral intervention increased the prophylactic use of oxytocin during the third stage of labor and reduced the use of episiotomy. (ClinicalTrials.gov number, NCT00070720 [ClinicalTrials.gov]; Current Controlled Trials number, ISRCTN82417627 [controlled-trials.com].).
                Copyright 2008 Massachusetts Medical Society.
Because there were significant methodological limitations and the observed effect sizes were small, it is not appropriate to recommend any specific antenatal BF education.There is an urgent need to conduct RCTs with adequate power to evaluate the effectiveness of antenatal BF education.