Dataset Information

DECIDE: a cluster-randomized controlled trial to reduce unnecessary caesarean deliveries in Burkina Faso.

ABSTRACT:

Background

In Burkina Faso, facility-based caesarean delivery rates have markedly increased since the national subsidy policy for deliveries and emergency obstetric care was implemented in 2006. Effective and safe strategies are needed to prevent unnecessary caesarean deliveries.

Methods

We conducted a cluster-randomized controlled trial of a multifaceted intervention at 22 referral hospitals in Burkina Faso. The evidence-based intervention was designed to promote the use of clinical algorithms for caesarean decision-making using in-site training, audits and feedback of caesarean indications and SMS reminders. The primary outcome was the change in the percentage of unnecessary caesarean deliveries. Unnecessary caesareans were defined on the basis of the literature review and expert consensus. Data were collected daily using a standardized questionnaire, in the same way at both the intervention and control hospitals. Caesareans were classified as necessary or unnecessary in the same way, in both arms of the trial using a standardized computer algorithm.

Results

A total of 2138 and 2036 women who delivered by caesarean section were analysed in the pre and post-intervention periods, respectively. A significant reduction in the percentage of unnecessary caesarean deliveries was evident from the pre- to post-intervention period in the intervention group compared with the control group (18.96 to 6.56% and 18.27 to 23.30% in the intervention and control groups, respectively; odds ratio [OR] for incremental change over time, adjusted for hospital and patient characteristics, 0.22; 95% confidence interval [CI], 0.14 to 0.34; P < 0.001; adjusted risk difference, - 17.02%; 95% CI, - 19.20 to - 13.20%). The intervention did not significantly affect the rate of maternal death (0.75 to 0.19% and 0.92 to 0.40% in the intervention and control groups, respectively; adjusted OR 0.32; 95% CI 0.04 to 2.23; P = 0.253) or intrapartum-related neonatal death (4.95 to 6.32% and 5.80 to 4.29% in the intervention and control groups, respectively, adjusted OR 1.73; 95% CI 0.82 to 3.66; P = 0.149). The overall perinatal mortality data were not available.

Conclusion

Promotion and training on clinical algorithms for decision-making, audit and feedback and SMS reminders reduced unnecessary caesarean deliveries, compared with usual care in a low-resource setting.

Trial registration

The DECIDE trial is registered on the Current Controlled Trials website: ISRCTN48510263 .

SUBMITTER: Kabore C

PROVIDER: S-EPMC6498483 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Publications

DECIDE: a cluster-randomized controlled trial to reduce unnecessary caesarean deliveries in Burkina Faso.

Kaboré Charles C Ridde Valéry V Chaillet Nils N Yaya Bocoum Fadima F Betrán Ana Pilar AP Dumont Alexandre A

BMC medicine 20190502 1

<h4>Background</h4>In Burkina Faso, facility-based caesarean delivery rates have markedly increased since the national subsidy policy for deliveries and emergency obstetric care was implemented in 2006. Effective and safe strategies are needed to prevent unnecessary caesarean deliveries.<h4>Methods</h4>We conducted a cluster-randomized controlled trial of a multifaceted intervention at 22 referral hospitals in Burkina Faso. The evidence-based intervention was designed to promote the use of clini ...[more]

PMID: 31046752

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Project description:BackgroundWidespread increases in caesarean section (CS) rates have sparked concerns about risks to mothers and infants and rising healthcare costs. A multicentre, two-arm, cluster-randomized trial in Quebec, Canada assessed whether an audit and feedback intervention targeting health professionals would reduce CS rates for pregnant women compared to usual care, and concluded that it reduced CS rates without adverse effects on maternal or neonatal health. The effect was statistically significant but clinically small. We assessed cost-effectiveness to inform scale-up decisions.MethodsA prospective economic evaluation was undertaken using individual patient data from the Quality of Care, Obstetrics Risk Management, and Mode of Delivery (QUARISMA) trial (April 2008 to October 2011). Analyses took a healthcare payer perspective. The time horizon captured hospital-based costs and clinical events for mothers and neonates from labour onset to 3 months postpartum. Resource use was identified and measured from patient charts and valued using standardized government sources. We estimated the changes in CS rates and costs for the intervention group (versus controls) between the baseline and post-intervention periods. We examined heterogeneity between clinical subgroups of high-risk versus low-risk pregnancies and estimated the joint uncertainty in cost-effectiveness over 20,000 trial simulations. We decomposed costs to identify drivers of change.ResultsThe intervention group experienced per-patient reductions of 0.005 CS (95% confidence interval (CI): -0.015 to 0.004, P = 0.09) and $180 (95% CI: -$277 to - $83, P < 0.001). Women with low-risk pregnancies experienced statistically significant reductions in CS rates and costs; changes for the high-risk subgroup were not significant. The intervention was "dominant" (effective in reducing CS and less costly than usual care) in 86.08% of simulations. It reduced costs in 99.99% of simulations. Cost reductions were driven by lower rates of neonatal complications in the intervention group (-$190, 95% CI: -$255 to - $125, P < 0.001). Given 88,000 annual provincial births, a similar intervention could save $15.8 million (range: $7.3 to $24.4 million) in Quebec annually.ConclusionsFrom a healthcare payer perspective, a multifaceted intervention involving audits and feedback resulted in a small reduction in caesarean deliveries and important cost savings. Cost reductions are consistent with improved quality of care in intervention group hospitals.Trial registrationInternational Clinical Trials Registry Platform, ISRCTN95086407 . Registered on 23 October 2007.

Project description:ObjectiveTo establish the views and experiences of healthcare professionals in relation to interventions targeted at them to reduce unnecessary caesareans.DesignQualitative evidence synthesis.SettingStudies undertaken in high-income, middle-income and low-income settings.Data sourcesSeven databases (CINAHL, MEDLINE, PsychINFO, Embase, Global Index Medicus, POPLINE and African Journals Online). Studies published between 1985 and June 2017, with no language or geographical restrictions. We hand-searched reference lists and key citations using Google Scholar.Study selectionQualitative or mixed-method studies reporting health professionals' views.Data extraction and synthesisTwo authors independently assessed study quality prior to extraction of primary data and authors' interpretations. The data were compared and contrasted, then grouped into summary of findings (SoFs) statements, themes and a line of argument synthesis. All SoFs were Confidence in the Evidence from Reviews of Qualitative research (GRADE-CERQual) assessed.Results17 papers were included, involving 483 health professionals from 17 countries (nine high-income, six middle-income and two low-income). Fourteen SoFs were identified, resulting in three core themes: philosophy of birth (four SoFs); (2) social and cultural context (five SoFs); and (3) negotiation within system (five SoFs). The resulting line of argument suggests three key mechanisms of effect for change or resistance to change: prior beliefs about birth; willingness or not to engage with change, especially where this entailed potential loss of income or status (including medicolegal barriers); and capacity or not to influence local community and healthcare service norms and values relating to caesarean provision.ConclusionFor maternity care health professionals, there is a synergistic relationship between their underpinning philosophy of birth, the social and cultural context they are working within and the extent to which they were prepared to negotiate within health system resources to reduce caesarean rates. These findings identify potential mechanisms of effect that could improve the design and efficacy of change programmes to reduce unnecessary caesareans.Prospero registration numberCRD42017059455.

Project description:BackgroundThe Pregnancy and Newborn Diagnostic Assessment (PANDA) system is a digital clinical decision support tool that can facilitate diagnosis and decision-making by health care personnel in antenatal care (ANC). Studies conducted in Madagascar and Burkina Faso showed that PANDA is a feasible system acceptable to various stakeholders.ObjectiveThis study primarily aims to evaluate the effects of the PANDA system on ANC quality at rural health facilities in Burkina Faso. The secondary objectives of this study are to test the effects of the PANDA system on women's satisfaction, women's knowledge on birth preparedness and complication readiness, maternal and child health service use, men's involvement in maternal health service utilization, and women's contraception use at 6 weeks postpartum. Further, we will identify the factors that hinder or promote such an app and contribute to cost-effectiveness analysis.MethodsThis is a randomized controlled trial implementing the PANDA system in 2 groups of health facilities (intervention and comparison groups) randomized using a matched-pair method. We included pregnant women who were <20 weeks pregnant during their first antenatal consultation in health facilities, and we followed up with them until their sixth week postpartum. Thirteen health centers were included, and 423 and 272 women were enrolled in the intervention and comparison groups, respectively. The primary outcome is a binary variable derived from the quality score, coded 1 (yes) for women with at least 75% of the total score and 0 if not. Data were collected electronically using tablets by directly interviewing the women and by extracting data from ANC registers, delivery registers, ANC cards, and health care records. The study procedures were standardized across all sites. We will compare unadjusted and adjusted primary outcome results (ANC quality scores) between the 2 study arms. We added a qualitative evaluation of the implementation of the PANDA system to identify barriers and catalysts. We also included an economic evaluation to determine whether the PANDA strategy is more cost-effective than the usual ANC strategy.ResultsThe enrollment ran from July 2020 to January 2021 due to the COVID-19 pandemic. Data collection ended in September 2022. Data analyses started in January 2023, ended in June 2023, and the results are expected to be published in February 2024.ConclusionsThe PANDA system is one of the most comprehensive apps for ANC because it has many features. However, the use of computerized systems for ANC is limited. Therefore, our trial will be beneficial for evaluating the intrinsic capacity of the PANDA system to improve the quality of care. By including qualitative research and economic evaluation, our findings will be significant because electronic consultation registries are expected to be used for maternal health care in the future in Burkina Faso.Trial registrationPan-African Clinical Trials Registry (PACTR) PACTR202009861550402; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12374.International registered report identifier (irrid)DERR1-10.2196/37136.

Project description:The period from conception to 24 months of age is a crucial window for nutrition interventions. Personalized maternal counseling may improve childbirth outcomes, growth, and health. We assessed the effectiveness of facility-based personalized maternal nutrition counseling (from pregnancy to 18 months after birth) in improving child growth and health in rural Burkina Faso. We conducted a paired cluster randomized controlled trial in a rural district of Burkina Faso with 12 primary health centers (clusters). Healthcare providers in the intervention centers received patient-centered communication and nutrition counseling training. Pregnant women in the third trimester living in the center catchment areas and intending to stay for the next 2 years were prospectively included. We followed 2253 mother-child pairs quarterly until the child was aged 18 months. Women were interviewed about counseling experiences, dietary practices during pregnancy, and their child's feeding practices and morbidity history. Anthropometric measurements were taken at each visit using standardized methods. The primary outcomes were the cumulative incidence of wasting, and changes in child weight-for-height z-score (WHZ). Secondary outcomes were the women's prenatal dietary practices, early breastfeeding practices, exclusive breastfeeding, timely introduction of complementary food, child's feeding frequency and dietary diversity, children's mean birth weight, endpoint prevalence of stunting, and cumulative incidence of diarrhea, fever, and acute respiratory infection. All analyses were by intention-to-treat using mixed effects models. The intervention and control arms each included six health centers. Mothers in the intervention arm had a significantly higher exposure to counseling with 11.2% for breastfeeding techniques to 75.7% for counseling on exclusive breastfeeding. Mothers of infants below 6 months of age in the intervention arm were more likely to exclusively breastfeed (54.3% vs 42.3%; Difference of Proportion (DP) 12.8%; 95% CI: 2.1, 23.6; p = 0.020) as compared to the control arm. Between 6 and 18 months of age, more children in the intervention arm benefited from the required feeding frequency (68.8% vs 53.4%; DP 14.1%; 95% CI: 9.0, 19.2; p<0.001) and a larger proportion had a minimum dietary diversity (28.6% vs 22.0%; DP 5.9%; 95% CI: 2.7, 9.2; p<0.001). Birth weight of newborns in the intervention arm was on average 84.8 g (p = 0.037) larger compared to the control arm. However, we found no significant differences in child anthropometry or morbidity between study arms. Facility-based personalized maternal nutrition counseling was associated with an improved prenatal dietary practices, Infant and Young Child Feeding practices, and child birth weight. Complementary strategies are warranted to obtain meaningful impact on child growth and morbidity. This includes strategies to ensure good coverage of facility-based services and effective nutrition/care practices in early childhood.

Dataset Information

DECIDE: a cluster-randomized controlled trial to reduce unnecessary caesarean deliveries in Burkina Faso.

Background

Methods

Results

Conclusion

Trial registration

Publications

DECIDE: a cluster-randomized controlled trial to reduce unnecessary caesarean deliveries in Burkina Faso.

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