Funding for this research was provided by:
Centre Hospitalier départemental de Vendée
Received: 14 June 2019
Accepted: 16 May 2020
First Online: 12 June 2020
Ethics approval and consent to participate
: All participants will be told about the study, and written information will be given by the attending physician or midwife during the eighth month. Written consent will be obtained by the medical team in charge of the study before inclusion (attending physician or midwife). The study protocol and this consent procedure were approved by the Angers Committee Ouest II for the Protection of Research Subjects (Ethics Committee) on 17 January 2017 (EudraCT 2016-002786-62) and by the ANSM on 14 April 2017 (17-0057A-32). All participants will undergo the informed consent process using institutional review board–approved consent documents. The ROPISO trial was sponsored by the La Roche sur Yon Hospital. This trial was registered with clinicaltrials.gov (NCT03084549) on 14 April 2017 and includes all items from the World Health Organization (WHO) Trial Registration Data Set (InternalRef removed) [CitationRef removed].
: Not applicable.
: The authors declare that they have no competing interests.