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Involving male partners in maternity care in Burkina Faso: a randomized controlled trial.

ABSTRACT: Objective:To determine whether an intervention to involve the male partners of pregnant women in maternity care influenced care-seeking, healthy breastfeeding and contraceptive practices after childbirth in urban Burkina Faso. Methods:In a non-blinded, multicentre, parallel-group, superiority trial, 1144 women were assigned by simple randomization to two study arms: 583 entered the intervention arm and 561 entered the control arm. All women were cohabiting with a male partner and had a low-risk pregnancy. Recruitment took place at 20 to 36 weeks' gestation at five primary health centres in Bobo-Dioulasso. The intervention comprised three educational sessions: (i) an interactive group session during pregnancy with male partners only, to discuss their role; (ii) a counselling session during pregnancy for individual couples; and (iii) a postnatal couple counselling session. The control group received routine care only. We followed up participants at 3 and 8 months postpartum. Findings:The follow-up rate was over 96% at both times. In the intervention arm, 74% (432/583) of couples or men attended at least two study sessions. Attendance at two or more outpatient postnatal care consultations was more frequent in the intervention than the control group (risk difference, RD: 11.7%; 95% confidence interval, CI: 6.0 to 17.5), as was exclusive breastfeeding 3 months postpartum (RD: 11.4%; 95% CI: 5.8 to 17.2) and effective modern contraception use 8 months postpartum (RD: 6.4%; 95% CI: 0.5 to 12.3). Conclusion:Involving men as supportive partners in maternity care was associated with better adherence to recommended healthy practices after childbirth.

SUBMITTER: Daniele MA

PROVIDER: S-EPMC6022615 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Involving male partners in maternity care in Burkina Faso: a randomized controlled trial.

Daniele Marina As MA Ganaba Rasmané R Sarrassat Sophie S Cousens Simon S Rossier Clémentine C Drabo Seydou S Ouedraogo Djeneba D Filippi Veronique V

Bulletin of the World Health Organization 20180604 7

<h4>Objective</h4>To determine whether an intervention to involve the male partners of pregnant women in maternity care influenced care-seeking, healthy breastfeeding and contraceptive practices after childbirth in urban Burkina Faso.<h4>Methods</h4>In a non-blinded, multicentre, parallel-group, superiority trial, 1144 women were assigned by simple randomization to two study arms: 583 entered the intervention arm and 561 entered the control arm. All women were cohabiting with a male partner and ...[more]

PMID: 29962548

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Project description:BackgroundIn 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.MethodsWe 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.ResultsA 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.ConclusionPromotion 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 registrationThe DECIDE trial is registered on the Current Controlled Trials website: ISRCTN48510263 .

Project description:BackgroundAntibiotic use during early infancy has been linked to childhood obesity in high-income countries. We evaluated whether a single oral dose of azithromycin administered during infant-well visits led to changes in infant growth outcomes at 6 months of age in a setting with a high prevalence of undernutrition in rural Burkina Faso.Methods and findingsInfants were enrolled from September 25, 2019, until October 22, 2022, in a randomized controlled trial designed to evaluate the efficacy of a single oral dose of azithromycin (20 mg/kg) compared to placebo when administered during well-child visits for prevention of infant mortality. The trial found no evidence of a difference in the primary endpoint. This paper presents prespecified secondary anthropometric endpoints including weight gain (g/day), height change (mm/day), weight-for-age Z-score (WAZ), weight-for-length Z-score (WLZ), length-for-age Z-score (LAZ), and mid-upper arm circumference (MUAC). Infants were eligible for the trial if they were between 5 and 12 weeks of age, able to orally feed, and their families were planning to remain in the study area for the duration of the study. Anthropometric measurements were collected at enrollment (5 to 12 weeks of age) and 6 months of age. Among 32,877 infants enrolled in the trial, 27,298 (83%) were followed and had valid anthropometric measurements at 6 months of age. We found no evidence of a difference in weight gain (mean difference 0.03 g/day, 95% confidence interval (CI) -0.12 to 0.18), height change (mean difference 0.004 mm/day, 95% CI -0.05 to 0.06), WAZ (mean difference -0.004 SD, 95% CI -0.03 to 0.02), WLZ (mean difference 0.001 SD, 95% CI -0.03 to 0.03), LAZ (mean difference -0.005 SD, 95% CI -0.03 to 0.02), or MUAC (mean difference 0.01 cm, 95% CI -0.01 to 0.04). The primary limitation of the trial was that measurements were only collected at enrollment and 6 months of age, precluding assessment of shorter-term or long-term changes in growth.ConclusionsSingle-dose azithromycin does not appear to affect weight and height outcomes when administered during early infancy.Trial registrationClinicalTrials.gov NCT03676764.

Project description:BackgroundAzithromycin is a broad-spectrum antibiotic that has moderate antimalarial activity and has been shown to reduce all-cause mortality when biannually administered to children under five in high mortality settings in sub-Saharan Africa. One potential mechanism for this observed reduction in mortality is via a reduction in malaria transmission.MethodsWe evaluated whether a single oral dose of azithromycin reduces malaria positivity by rapid diagnostic test (RDT). We conducted an individually randomized placebo-controlled trial in Burkina Faso during the high malaria transmission season in August 2020. Children aged 8 days to 59 months old were randomized to a single oral dose of azithromycin (20 mg/kg) or matching placebo. At baseline and 14 days following treatment, we administered a rapid diagnostic test (RDT) to detect Plasmodium falciparum and measured tympanic temperature for all children. Caregiver-reported adverse events and clinic visits were recorded at the day 14 visit.ResultsWe enrolled 449 children with 221 randomized to azithromycin and 228 to placebo. The median age was 32 months and 48% were female. A total of 8% of children had a positive RDT for malaria at baseline and 11% had a fever (tympanic temperature ≥ 37.5 °C). In the azithromycin arm, 8% of children had a positive RDT for malaria at 14 days compared to 7% in the placebo arm (P = 0.65). Fifteen percent of children in the azithromycin arm had a fever ≥ 37.5 °C compared to 21% in the placebo arm (P = 0.12). Caregivers of children in the azithromycin group had lower odds of reporting fever as an adverse event compared to children in the placebo group (OR 0.41, 95% CI 0.18-0.96, P = 0.04). Caregiver-reported clinic visits were uncommon, and there were no observed differences between arms (P = 0.32).ConclusionsWe did not find evidence that a single oral dose of azithromycin reduced malaria positivity during the high transmission season. Caregiver-reported fever occurred less often in children receiving azithromycin compared to placebo, indicating that azithromycin may have some effect on non-malarial infections. Trial registration Clinicaltrials.gov NCT04315272, registered 19/03/2020.

Project description:BackgroundProviding balanced energy-protein (BEP) supplements is a promising intervention to improve birth outcomes in low- and middle-income countries (LMICs); however, evidence is limited. We aimed to assess the efficacy of fortified BEP supplementation during pregnancy to improve birth outcomes, as compared to iron-folic acid (IFA) tablets, the standard of care.Methods and findingsWe conducted an individually randomized controlled efficacy trial (MIcronutriments pour la SAnté de la Mère et de l'Enfant [MISAME]-III) in 6 health center catchment areas in rural Burkina Faso. Pregnant women, aged 15 to 40 years with gestational age (GA) <21 completed weeks, were randomly assigned to receive either fortified BEP supplements and IFA (intervention) or IFA (control). Supplements were provided during home visits, and intake was supervised on a daily basis by trained village-based project workers. The primary outcome was prevalence of small-for-gestational age (SGA) and secondary outcomes included large-for-gestational age (LGA), low birth weight (LBW), preterm birth (PTB), gestational duration, birth weight, birth length, Rohrer's ponderal index, head circumference, thoracic circumference, arm circumference, fetal loss, and stillbirth. Statistical analyses followed the intention-to-treat (ITT) principle. From October 2019 to December 2020, 1,897 pregnant women were randomized (960 control and 937 intervention). The last child was born in August 2021, and birth anthropometry was analyzed from 1,708 pregnancies (872 control and 836 intervention). A total of 22 women were lost to follow-up in the control group and 27 women in the intervention group. BEP supplementation led to a mean 3.1 percentage points (pp) reduction in SGA with a 95% confidence interval (CI) of -7.39 to 1.16 (P = 0.151), indicating a wide range of plausible true treatment efficacy. Adjusting for prognostic factors of SGA, and conducting complete cases (1,659/1,708, 97%) and per-protocol analysis among women with an observed BEP adherence ≥75% (1,481/1,708, 87%), did not change the results. The intervention significantly improved the duration of gestation (+0.20 weeks, 95% CI 0.05 to 0.36, P = 0.010), birth weight (50.1 g, 8.11 to 92.0, P = 0.019), birth length (0.20 cm, 0.01 to 0.40, P = 0.044), thoracic circumference (0.20 cm, 0.04 to 0.37, P = 0.016), arm circumference (0.86 mm, 0.11 to 1.62, P = 0.025), and decreased LBW prevalence (-3.95 pp, -6.83 to -1.06, P = 0.007) as secondary outcomes measures. No differences in serious adverse events [SAEs; fetal loss (21 control and 26 intervention) and stillbirth (16 control and 17 intervention)] between the study groups were found. Key limitations are the nonblinded administration of supplements and the lack of information on other prognostic factors (e.g., infection, inflammation, stress, and physical activity) to determine to which extent these might have influenced the effect on nutrient availability and birth outcomes.ConclusionsThe MISAME-III trial did not provide evidence that fortified BEP supplementation is efficacious in reducing SGA prevalence. However, the intervention had a small positive effect on other birth outcomes. Additional maternal and biochemical outcomes need to be investigated to provide further evidence on the overall clinical relevance of BEP supplementation.Trial registrationClinicalTrials.gov NCT03533712.

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.

Dataset Information

Involving male partners in maternity care in Burkina Faso: a randomized controlled trial.

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Involving male partners in maternity care in Burkina Faso: a randomized controlled trial.

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