{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T10:58:28Z","timestamp":1784890708857,"version":"3.55.0"},"reference-count":15,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2023,4,17]],"date-time":"2023-04-17T00:00:00Z","timestamp":1681689600000},"content-version":"unspecified","delay-in-days":16,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100014630","name":"Minist\u00e8re des Solidarit\u00e9s et de la Sant\u00e9","doi-asserted-by":"publisher","award":["PHRC-19-0065"],"award-info":[{"award-number":["PHRC-19-0065"]}],"id":[{"id":"10.13039\/501100014630","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,11,30]]},"published-print":{"date-parts":[[2023,4]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>It remains uncertain whether the most appropriate management for women with an unfavourable cervix after 24 hours of cervical ripening is repeating the ripening procedure or proceeding directly to induction by oxytocin. No adequately powered trial has compared these strategies. We hypothesise that induction of labour with oxytocin among women who have just undergone an ineffective first ripening procedure is not associated with a higher risk of caesarean delivery than a repeated cervical ripening with prostaglandins.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>We will conduct a multicentre, non-inferiority, open-label, randomised controlled trial aimed at comparing labour induction by oxytocin with a second cervical ripening that uses prostaglandins (slow-release vaginal dinoprostone; oral misoprostol 25\u2009\u00b5g; dinoprostone vaginal gel 2\u2009mg). Women (n=1494) randomised in a 1:1 ratio in 10 French maternity units must be \u226518 years with a singleton fetus in vertex presentation, at a term from \u226537+0 weeks of gestation, and have just completed a 24-hour cervical ripening procedure by any method (pharmacological or mechanical) with a Bishop score \u22646. Exclusion criteria comprise being in labour, having more than 3 contractions per 10\u2009min, or a prior caesarean delivery or a history of uterine surgery, or a fetus with antenatally suspected severe congenital abnormalities or a non-reassuring fetal heart rate. The primary endpoint will be the caesarean delivery rate, regardless of indication. Secondary outcomes concern delivery, perinatal morbidity, maternal satisfaction and health economic evaluations. The nature of the assessed procedures prevents masking the study investigators and patients to group assignment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>All participants will provide written informed consent. The ethics committee \u2018Comit\u00e9 de Protection des Personnes Ile de France VII\u2019 approved this study on 2 April 2021 (No 2021-000989-15). Study findings will be submitted for publication and presented at relevant conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\" xlink:href=\"NCT04949633\">NCT04949633<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-058282","type":"journal-article","created":{"date-parts":[[2023,4,17]],"date-time":"2023-04-17T10:45:18Z","timestamp":1681728318000},"page":"e058282","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["Oxytocin versus prostaglandins for labour Induction of women with an unfavourable cervix after 24 hours of cervical ripening (OPIC): protocol for an open multicentre randomised non-inferiority trial"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct04949633","registry":"10.18810\/clinical-trials-gov","type":"preResults"},{"clinical-trial-number":"nct04949633","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0359-1769","authenticated-orcid":false,"given":"Marion","family":"De Berti","sequence":"first","affiliation":[{"name":"Maternit\u00e9 Olympe de Gouges, Centre Hospitalier R\u00e9gional Universitaire Tours, Universit\u00e9 de Tours, Tours, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Am\u00e9lie","family":"Le Gouge","sequence":"additional","affiliation":[{"name":"INSERM CIC 1415, CHRU de Tours, Tours, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3673-1724","authenticated-orcid":false,"given":"Fanny","family":"Monmousseau","sequence":"additional","affiliation":[{"name":"Tours University Hospital - Health-Economic Evaluation Unit, CHRU de Tours, Tours Area, France"},{"name":"University of Tours - EA 7505-Education Ethics Health, Tours Area, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denis","family":"Gallot","sequence":"additional","affiliation":[{"name":"Service de Gyn\u00e9cologie-Obst\u00e9trique, H\u00f4pital d'Estaing, CHU de Clermont-Ferrand, Maternit\u00e9 Clermont Ferrand, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lo\u00efc","family":"Sentilhes","sequence":"additional","affiliation":[{"name":"Service de Gyn\u00e9cologie-Obst\u00e9trique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norbert","family":"Winer","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, University Hospital of Nantes, 44093 Nantes, NUN, INRAE, UMR 1280, PhAN, F-44000 Universit\u00e9 de Nantes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guillaume","family":"Legendre","sequence":"additional","affiliation":[{"name":"Service de Gyn\u00e9cologie-Obst\u00e9trique, Centre Hospitalier Universitaire d'Angers, Angers, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raoul","family":"Desbriere","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, H\u00f4pital Saint Joseph, Marseille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aude","family":"Girault","sequence":"additional","affiliation":[{"name":"Maternit\u00e9 Port-Royal, AP-HP, H\u00f4pital Cochin, FHU PREMA, F-75014, Paris, France"},{"name":"Universit\u00e9 de Paris, CRESS, Obstetrical Perinatal and Pediatric Epidemiology Research Team, EPOP\u00e9, INSERM, INRAE,F-75004, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jordan","family":"Pozzi","sequence":"additional","affiliation":[{"name":"CHU Brest, H\u00f4pital Morvan, service de gyn\u00e9cologie-obst\u00e9trique, Brest, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bertrand","family":"Gachon","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, La Mil\u00e9trie University Hospital, Poitiers France; Nantes University, Movement - Interactions - Performance, MIP, EA 4334, F-44000 Nantes, France; INSERM CIC-P 1402, La Mil\u00e9trie University Hospital, Poitiers, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thiphaine","family":"Barjat","sequence":"additional","affiliation":[{"name":"Service de Gyn\u00e9cologie Obst\u00e9trique, CHU de Saint Etienne, Saint Etienne, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franck","family":"Perrotin","sequence":"additional","affiliation":[{"name":"Maternit\u00e9 Olympe de Gouges, Centre Hospitalier R\u00e9gional Universitaire Tours, Universit\u00e9 de Tours, Tours, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sol\u00e8ne","family":"Brunet-Houdard","sequence":"additional","affiliation":[{"name":"Tours University Hospital - Health-Economic Evaluation Unit, CHRU de Tours, Tours Area, France"},{"name":"University of Tours - EA 7505-Education Ethics Health, Tours Area, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Diguisto","sequence":"additional","affiliation":[{"name":"Maternit\u00e9 Olympe de Gouges, Centre Hospitalier R\u00e9gional Universitaire Tours, Universit\u00e9 de Tours, Tours, France"},{"name":"Universit\u00e9 de Paris, CRESS, Obstetrical Perinatal and Pediatric Epidemiology Research Team, EPOP\u00e9, INSERM, INRAE,F-75004, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,4,17]]},"reference":[{"key":"2025120518323645000_13.4.e058282.1","doi-asserted-by":"crossref","first-page":"701","DOI":"10.1016\/j.jogoh.2017.09.002","article-title":"Trends in perinatal health in metropolitan france from 1995 to 2016: results from the french national perinatal surveys","volume":"46","author":"Blondel","year":"2017","journal-title":"J Gynecol Obstet Hum Reprod"},{"key":"2025120518323645000_13.4.e058282.2","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1016\/j.jogoh.2017.11.006","article-title":"Labour induction practices in france: a population-based declarative survey in 94 maternity units","volume":"47","author":"Blanc-Petitjean","year":"2018","journal-title":"J Gynecol Obstet Hum Reprod"},{"key":"2025120518323645000_13.4.e058282.3","doi-asserted-by":"publisher","DOI":"10.1177\/1933719115618272"},{"key":"2025120518323645000_13.4.e058282.4","doi-asserted-by":"crossref","DOI":"10.1186\/1471-2393-14-350","article-title":"Effects of induction of labour versus expectant management in women with impending post-term pregnancies: the 41 week \u2013 42 week dilemma","volume":"14","author":"Kortekaas","year":"2014","journal-title":"BMC Pregnancy Childbirth"},{"key":"2025120518323645000_13.4.e058282.5","doi-asserted-by":"crossref","DOI":"10.1155\/2013\/745159","article-title":"Cervical ripening in the netherlands: A survey","volume":"2013","author":"Huisman","year":"2013","journal-title":"Obstet Gynecol Int"},{"key":"2025120518323645000_13.4.e058282.6","doi-asserted-by":"crossref","DOI":"10.1186\/s13063-019-3985-0","article-title":"Is there an interest in repeating the vaginal administration of dinoprostone (propess\u00ae), to promote induction of labor of pregnant women at term? 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