Bardou Marc, Crépon Bruno, Bertaux Anne-Claire, Godard-Marceaux Aurélie, Eckman-Lacroix Astrid, Thellier Elise, Falchier Frédérique, Deruelle Philippe, Doret Muriel, Carcopino-Tusoli Xavier, Schmitz Thomas, Barjat Thiphaine, Morin Mathieu, Perrotin Franck, Hatem Ghada, Deneux-Tharaux Catherine, Fournel Isabelle, Laforet Laurent, Meunier-Beillard Nicolas, Duflo Esther, Le Ray Isabelle
Centre d'Investigation Clinique INSERM 1432, Centre Hospitalier Universitaire de Dijon, Dijon, Bourgogne, France.
Centre de Recherche INSERM LNC-UMR1231, UFR Sciences Santé, Dijon, France.
BMJ Open. 2017 Oct 30;7(10):e017321. doi: 10.1136/bmjopen-2017-017321.
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.
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 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.
NCT02402855; pre-results.
建议孕期进行产前检查以改善新生儿和产妇结局。社会经济地位较低（SES）的女性对推荐的产前检查依从性较差，围产期不良结局风险较高。多项鼓励最佳孕期随访的尝试结果存在争议，尤其是在高收入国家。很少有研究评估鼓励产前检查的经济激励措施，且没有研究将母婴事件作为主要结局。我们的研究旨在确定经济激励措施是否能改善高收入国家社会经济地位较低女性的妊娠结局。
这项实用的整群随机临床试验纳入符合以下标准的孕妇：（1）年龄在18岁以上；（2）妊娠26周前首次产检；（3）属于社会经济弱势群体。干预措施是根据按时参加预定的孕期随访咨询提供经济激励。整群为2个月周期，各中心随机轮换。母婴发病率和死亡率的综合结局是主要终点。次要终点包括分别评估的产妇或新生儿结局、对干预措施认知的定性评估以及成本效益分析，为此将通过法国健康保险数据库对儿童随访至一岁末。该研究于2016年6月开始，基于干预组主要终点预期从18%降至14%，我们计划每组纳入2000名女性。
2014年9月28日首次获得伦理批准。已设立独立的数据安全和监测委员会。主要试验及每项次要分析的结果将提交至同行评审期刊发表。
NCT02402855；预结果。
