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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e017321.full.pdf
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2.08 MB
Format
Adobe PDF
Checksum (MD5)
558c199b19864c465436abc1ff8cf068
Author(s)
Bardou, Marc
Crépon, Bruno
Bertaux, Anne-Claire
Godard-Marceaux, Aurélie
Eckman-Lacroix, Astrid
Thellier, Elise
Falchier, Frédérique
Deruelle, Philippe
Doret, Muriel
Carcopino-Tusoli, Xavier
Date Issued
September 2017
Journal
BMJ Open
Publisher
BMJ
Citation
Bardou, Marc, et al. “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.” BMJ Open, vol. 7, no. 10, Oct. 2017, p. e017321.
Version
Final published version
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.
MIT Department
Massachusetts Institute of Technology. Department of Economics
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Creative Commons Attribution-NonCommercial 4.0 International
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DOI of Published Version
https://doi.org/10.1136/BMJOPEN-2017-017321
