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NAITRE study on the impact of conditional cash transfer on poor pregnancy outcomes in underprivileged women: protocol for a nationwide pragmatic cluster-randomised superiority clinical trial in France.

ABSTRACT: INTRODUCTION:Prenatal care is recommended during pregnancy to improve neonatal and maternal outcomes. Women of lower socioeconomic status (SES) are less compliant to recommended prenatal care and suffer a higher risk of adverse perinatal outcomes. Several attempts to encourage optimal pregnancy follow-up have shown controversial results, particularly in high-income countries. Few studies have assessed financial incentives to encourage prenatal care, and none reported materno-fetal events as the primary outcome. Our study aims to determine whether financial incentives could improve pregnancy outcomes in women with low SES in a high-income country. METHODS AND ANALYSIS:This pragmatic cluster-randomised clinical trial includes pregnant women with the following criteria: (1) age above 18 years, (2) first pregnancy visit before 26 weeks of gestation and (3) belonging to a socioeconomically disadvantaged group. The intervention consists in offering financial incentives conditional on attending scheduled pregnancy follow-up consultations. Clusters are 2-month periods with random turnover across centres. A composite outcome of maternal and neonatal morbidity and mortality is the primary endpoint. Secondary endpoints include maternal or neonatal outcomes assessed separately, qualitative assessment of the perception of the intervention and cost-effectiveness analysis for which children will be followed to the end of their first year through the French health insurance database. The study started in June 2016, and based on an expected decrease in the primary endpoint from 18% to 14% in the intervention group, we plan to include 2000 women in each group. ETHICS AND DISSEMINATION:Ethics approval was first gained on 28 September 2014. An independent data security and monitoring committee has been established. Results of the main trial and each of the secondary analyses will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:NCT02402855; pre-results.

SUBMITTER: Bardou M

PROVIDER: S-EPMC5665235 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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NAITRE study on the impact of conditional cash transfer on poor pregnancy outcomes in underprivileged women: protocol for a nationwide pragmatic cluster-randomised superiority clinical trial in France.

Bardou Marc M Crépon Bruno B Bertaux Anne-Claire AC Godard-Marceaux Aurélie A Eckman-Lacroix Astrid A Thellier Elise E Falchier Frédérique F Deruelle Philippe P Doret Muriel M Carcopino-Tusoli Xavier X Schmitz Thomas T Barjat Thiphaine T Morin Mathieu M Perrotin Franck F Hatem Ghada G Deneux-Tharaux Catherine C Fournel Isabelle I Laforet Laurent L Meunier-Beillard Nicolas N Duflo Esther E Le Ray Isabelle I

BMJ open 20171030 10

<h4>Introduction</h4>Prenatal care is recommended during pregnancy to improve neonatal and maternal outcomes. Women of lower socioeconomic status (SES) are less compliant to recommended prenatal care and suffer a higher risk of adverse perinatal outcomes. Several attempts to encourage optimal pregnancy follow-up have shown controversial results, particularly in high-income countries. Few studies have assessed financial incentives to encourage prenatal care, and none reported materno-fetal events ...[more]

PMID: 29084796

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Project description:BackgroundAntenatal care (ANC), facility delivery and postnatal care (PNC) are proven to reduce maternal and child mortality and morbidity in high-burden settings. However, few pregnant rural women use these services sufficiently. This study aims to assess the impact, cost-effectiveness and scalability of conditional cash transfers to promote increased contact between pregnant women or women who have recently given birth and the formal healthcare system in Kenya.MethodsThe intervention tested is a conditional cash transfer to women for ANC health visits, a facility birth and PNC visits until their newborn baby reaches 1 year of age. The study is a cluster randomized controlled trial in Siaya County, Kenya. The trial clusters are 48 randomly selected public primary health facilities, 24 of which are in the intervention arm of the study and 24 in the control arm. The unit of randomization is the health facility. A target sample of 7200 study participants comprises pregnant women identified and recruited at their first ANC visit over a 12-month recruitment period and their subsequent newborns. All pregnant women attending one of the selected trial facilities for their first ANC visit during the recruitment period are eligible for the trial and invited to participate. Enrolled mothers are followed up at all health visits during their pregnancy, at facility delivery and for a number of visits after delivery. They are also contacted at three additional time points after enrolling in the study: 5-10days after enrolment, 6 months after the expected delivery date and 12 27 months after birth. If they have not delivered in a facility, there is an additional follow-up 2 wees after the expected due date. The impact of the conditional cash transfers on maternal healthcare services and utilization will be measured by the trial's primary outcomes: the proportion of all eligible ANC visits made during pregnancy, delivery at a health facility, the proportion of all eligible PNC visits attended, the proportion of referrals attended during the pregnancy and the postnatal period, and the proportion of eligible child immunization appointments attended. Secondary outcomes include; health screening and infection control, live birth, maternal and child survival 48 h after delivery, exclusive breastfeeding, post-partum contraceptive use and maternal and newborn morbidity. Data sources for the measurement of outcomes include routine health records, an electronic card-reader system and telephone surveys and focus group discussions. A full economic evaluation will be conducted to assess the cost of delivery and cost effectiveness of the intervention and the benefit incidence and equity impact of trial activities and outcomes.DiscussionThis trial will contribute to evidence on the effectiveness and cost-effectiveness of conditional cash transfers in facilitating health visits and promoting maternal and child health in rural Kenya and in other comparable contexts.Trial registrationClinicalTrials.gov, NCT03021070 . Registered on 13 January 2017.

Project description:Cash-transfer programmes can improve the wellbeing of vulnerable children, but few studies have rigorously assessed their effectiveness in sub-Saharan Africa. We investigated the effects of unconditional cash transfers (UCTs) and conditional cash transfers (CCTs) on birth registration, vaccination uptake, and school attendance in children in Zimbabwe.We did a matched, cluster-randomised controlled trial in ten sites in Manicaland, Zimbabwe. We divided each study site into three clusters. After a baseline survey between July, and September, 2009, clusters in each site were randomly assigned to UCT, CCT, or control, by drawing of lots from a hat. Eligible households contained children younger than 18 years and satisfied at least one other criteria: head of household was younger than 18 years; household cared for at least one orphan younger than 18 years, a disabled person, or an individual who was chronically ill; or household was in poorest wealth quintile. Between January, 2010, and January, 2011, households in UCT clusters collected payments every 2 months. Households in CCT clusters could receive the same amount but were monitored for compliance with several conditions related to child wellbeing. Eligible households in all clusters, including control clusters, had access to parenting skills classes and received maize seed and fertiliser in December, 2009, and August, 2010. Households and individuals delivering the intervention were not masked, but data analysts were. The primary endpoints were proportion of children younger than 5 years with a birth certificate, proportion younger than 5 years with up-to-date vaccinations, and proportion aged 6-12 years attending school at least 80% of the time. This trial is registered with ClinicalTrials.gov, number NCT00966849.1199 eligible households were allocated to the control group, 1525 to the UCT group, and 1319 to the CCT group. Compared with control clusters, the proportion of children aged 0-4 years with birth certificates had increased by 1·5% (95% CI -7·1 to 10·1) in the UCT group and by 16·4% (7·8-25·0) in the CCT group by the end of the intervention period. The proportions of children aged 0-4 years with complete vaccination records was 3·1% (-3·8 to 9·9) greater in the UCT group and 1·8% (-5·0 to 8·7) greater in the CCT group than in the control group. The proportions of children aged 6-12 years who attended school at least 80% of the time was 7·2% (0·8-13·7) higher in the UCT group and 7·6% (1·2-14·1) in the CCT group than in the control group.Our results support strategies to integrate cash transfers into social welfare programming in sub-Saharan Africa, but further evidence is needed for the comparative effectiveness of UCT and CCT programmes in this region.Wellcome Trust, the World Bank through the Partnership for Child Development, and the Programme of Support for the Zimbabwe National Action Plan for Orphans and Vulnerable Children.

Project description:BackgroundReducing poverty and improving access to health care are two of the most effective actions to decrease maternal mortality, and conditional cash transfer (CCT) programmes act on both. The aim of this study was to evaluate the effects of one of the world's largest CCT (the Brazilian Bolsa Familia Programme (BFP)) on maternal mortality during a period of 11 years.MethodsThe study had an ecological longitudinal design and used all 2548 Brazilian municipalities with vital statistics of adequate quality during 2004-2014. BFP municipal coverage was classified into four levels, from low to consolidated, and its duration effects were measured using the average municipal coverage of previous years. We used negative binomial multivariable regression models with fixed-effects specifications, adjusted for all relevant demographic, socioeconomic, and healthcare variables.ResultsBFP was significantly associated with reductions of maternal mortality proportionally to its levels of coverage and years of implementation, with a rate ratio (RR) reaching 0.88 (95%CI 0.81-0.95), 0.84 (0.75-0.96) and 0.83 (0.71-0.99) for intermediate, high and consolidated BFP coverage over the previous 11 years. The BFP duration effect was stronger among young mothers (RR 0.77; 95%CI 0.67-0.96). BFP was also associated with reductions in the proportion of pregnant women with no prenatal visits (RR 0.73; 95%CI 0.69-0.77), reductions in hospital case-fatality rate for delivery (RR 0.78; 95%CI 0.66-0.94) and increases in the proportion of deliveries in hospital (RR 1.05; 95%CI 1.04-1.07).ConclusionOur findings show that a consolidated and durable CCT coverage could decrease maternal mortality, and these long-term effects are stronger among poor mothers exposed to CCT during their childhood and adolescence, suggesting a CCT inter-generational effect. Sustained CCT coverage could reduce health inequalities and contribute to the achievement of the Sustainable Development Goal 3.1, and should be preserved during the current global economic crisis due to the COVID-19 pandemic.

Project description:ObjectivesGiven high maternal and child mortality rates, we assessed the impact of conditional cash transfers (CCTs) to retain women in the continuum of care (antenatal care (ANC), delivery at facility, postnatal care (PNC) and child immunisation).DesignWe conducted an unblinded 1:1 cluster-randomised controlled trial.Setting48 health facilities in Siaya County, Kenya were randomised. The trial ran from May 2017 to December 2019.Participants2922 women were recruited to the control and 2522 to the intervention arm.InterventionsAn electronic system recorded attendance and triggered payments to the participant's mobile for the intervention arm (US$4.5), and phone credit for the control arm (US$0.5). Eligibility criteria were resident in the catchment area and access to a mobile phone.Primary outcomesPrimary outcomes were any ANC, delivery, any PNC between 4 and 12 months after delivery, childhood immunisation and referral attendance to other facilities for ANC or PNC. Given problems with the electronic system, primary outcomes were obtained from maternal clinic books if participants brought them to data extraction meetings (1257 (50%) of intervention and 1053 (36%) control arm participants). Attendance at referrals to other facilities is not reported because of limited data.ResultsWe found a significantly higher proportion of appointments attended for ANC (67% vs 60%, adjusted OR (aOR) 1.90; 95% CI 1.36 to 2.66) and child immunisation (88% vs 85%; aOR 1.74; 95% CI 1.10 to 2.77) in intervention than control arm. No intervention effect was seen considering delivery at the facility (90% vs 92%; aOR 0.58; 95% CI 0.25 to 1.33) and any PNC attendance (82% vs 81%; aOR 1.25; 95% CI 0.74 to 2.10) separately. The pooled OR across all attendance types was 1.64 (1.28 to 2.10).ConclusionsDemand-side financing incentives, such as CCTs, can improve attendance for appointments. However, attention needs to be paid to the technology, the barriers that remain for delivery at facility and PNC visits and encouraging women to attend ANC visits within the recommended WHO timeframe.Trial registrationNCT03021070.

Project description:BackgroundLack of nutrition, inadequate housing, low education and limited access to quality care can negatively affect children's health over their lifetime. Implemented in 2003, the Bolsa Familia ("Family Stipend") Program (PBF) is a conditional cash transfer program targeting poor households in Brazil. This study investigates the long-term benefits of cash transfers through intergenerational transmission of health and poverty by assessing the early life exposure of the mother to the PBF.MethodsWe used data from the 100M SINASC-SIM cohort compiled and managed by the Center for Data and Knowledge Integration for Health (CIDACS), containing information about participation in the PBF and socioeconomic and health indicators. We analyzed five measures of newborn health: low (less than 2,500 g) and very low (less than 1,500 g) birth weight, premature (less than 37 weeks of gestation) and very premature (less than 28 weeks of gestation) birth, and the presence of some type of malformation (according to ICD-10 codes). Furthermore, we measured the early life exposure to the PBF of the mother as PBF coverage in the previous decade in the city where the mother was born. We applied multilevel logistic regression models to assess the associations between birth outcomes and PBF exposures.ResultsResults showed that children born in a household where the mother received BF were less likely to have low birth weight (OR 0.93, CI; 0.92-0.94), very low birth weight (0.87, CI; 0.84-0.89), as well as to be born after 37 weeks of gestation (OR 0.98, CI; 0.97-0.99) or 28 weeks of gestation (OR 0.93, CI; 0.88-0.97). There were no significant associations between households where the mother received BF and congenital malformation. On average, the higher the early life exposure to the PBF of the mother, the lower was the prevalence of low birth weight, very low birth weight and congenital malformation of the newborn. No trend was noted for preterm birth.ConclusionThe PBF might have indirect intergenerational effects on children's health. These results provide important implications for policymakers who have to decide how to effectively allocate resources to improve child health.

Project description:OBJECTIVES:To investigate the effectiveness of routine ultrasonography in the third trimester in reducing adverse perinatal outcomes in low risk pregnancies compared with usual care and the effect of this policy on maternal outcomes and obstetric interventions. DESIGN:Pragmatic, multicentre, stepped wedge cluster randomised trial. SETTING:60 midwifery practices in the Netherlands. PARTICIPANTS:13 046 women aged 16 years or older with a low risk singleton pregnancy. INTERVENTIONS:60 midwifery practices offered usual care (serial fundal height measurements with clinically indicated ultrasonography). After 3, 7, and 10 months, a third of the practices were randomised to the intervention strategy. As well as receiving usual care, women in the intervention strategy were offered two routine biometry scans at 28-30 and 34-36 weeks' gestation. The same multidisciplinary protocol for detecting and managing fetal growth restriction was used in both strategies. MAIN OUTCOME MEASURES:The primary outcome measure was a composite of severe adverse perinatal outcomes: perinatal death, Apgar score <4, impaired consciousness, asphyxia, seizures, assisted ventilation, septicaemia, meningitis, bronchopulmonary dysplasia, intraventricular haemorrhage, periventricular leucomalacia, or necrotising enterocolitis. Secondary outcomes were two composite measures of severe maternal morbidity, and spontaneous labour and birth. RESULTS:Between 1 February 2015 and 29 February 2016, 60 midwifery practices enrolled 13 520 women in mid-pregnancy (mean 22.8 (SD 2.4) weeks' gestation). 13 046 women (intervention n=7067, usual care n=5979) with data based on the national Dutch perinatal registry or hospital records were included in the analyses. Small for gestational age at birth was significantly more often detected in the intervention group than in the usual care group (179 of 556 (32%) v 78 of 407 (19%), P<0.001). The incidence of severe adverse perinatal outcomes was 1.7% (n=118) for the intervention strategy and 1.8% (n=106) for usual care. After adjustment for confounders, the difference between the groups was not significant (odds ratio 0.88, 95% confidence interval 0.70 to 1.20). The intervention strategy showed a higher incidence of induction of labour (1.16, 1.04 to 1.30) and a lower incidence of augmentation of labour (0.78, 0.71 to 0.85). Maternal outcomes and other obstetric interventions did not differ between the strategies. CONCLUSION:In low risk pregnancies, routine ultrasonography in the third trimester along with clinically indicated ultrasonography was associated with higher antenatal detection of small for gestational age fetuses but not with a reduced incidence of severe adverse perinatal outcomes compared with usual care alone. The findings do not support routine ultrasonography in the third trimester for low risk pregnancies. TRIAL REGISTRATION:Netherlands Trial Register NTR4367.

Dataset Information

NAITRE study on the impact of conditional cash transfer on poor pregnancy outcomes in underprivileged women: protocol for a nationwide pragmatic cluster-randomised superiority clinical trial in France.

Publications

NAITRE study on the impact of conditional cash transfer on poor pregnancy outcomes in underprivileged women: protocol for a nationwide pragmatic cluster-randomised superiority clinical trial in France.

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