Harm

The coordinating centre at Centre Hospitalier Universitaire Dijon-Bourgogne, Centre d’Investigations Cliniques (CIC INSERM 1432), takes responsibility for all aspects of the study: ethical, regulatory, study conduction, data management and publication strategy.

The steering committee is composed of the principal investigators of the first 10 centres, one representative from each perinatal care network involved in the study, a midwife, a social worker and a methodologist. A phone meeting is held every 4 months. The role of the steering committee is to ensure that the study is running according to study protocol and to share solutions to overcome difficulties in recruiting participants.

The data monitoring and safety committee (DSMC) is composed of two obstetricians, who specifically take care of socioeconomically disadvantaged women, a methodologist, an ethics specialist and a paediatrician. DSMC will essentially review results of the qualitative survey conducted during the first year and follow observed versus expected recruitment curves. If the qualitative survey were to suggest that the intervention stigmatises women, the scientific committee will have the right to stop the study. As women will be managed according to French guidelines during their antenatal and postnatal period and will thus not be affected by the study, no harm other than potential stigmatisation is expected. No interim analysis has been planned, as it would have had a significant impact on sample size.

The study has been deemed non-interventional by the ethics committee; as a result, by law no formal auditing will be conducted.