Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-13 @ 3:42 AM
Study NCT ID:
NCT03009435
Status:
UNKNOWN
Last Update Posted:
2017-01-04
First Post:
2016-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate (RMOS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 238}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'lastUpdateSubmitDate': '2016-12-30', 'studyFirstSubmitDate': '2016-12-19', 'studyFirstSubmitQcDate': '2016-12-30', 'lastUpdatePostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of spontaneous vaginal delivery', 'timeFrame': 'At the time of delivery'}]}, 'conditionsModule': {'conditions': ['Fetal Manual Rotation']}, 'referencesModule': {'references': [{'pmid': '33957650', 'type': 'DERIVED', 'citation': 'Verhaeghe C, Corroenne R, Spiers A, Descamps P, Gascoin G, Bouet PE, Parot-Schinkel E, Legendre G. Delivery Mode After Manual Rotation of Occiput Posterior Fetal Positions: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):999-1006. doi: 10.1097/AOG.0000000000004386.'}, {'pmid': '29444695', 'type': 'DERIVED', 'citation': 'Verhaeghe C, Parot-Schinkel E, Bouet PE, Madzou S, Biquard F, Gillard P, Descamps P, Legendre G. The impact of manual rotation of the occiput posterior position on spontaneous vaginal delivery rate: study protocol for a randomized clinical trial (RMOS). Trials. 2018 Feb 14;19(1):109. doi: 10.1186/s13063-018-2497-7.'}]}, 'descriptionModule': {'briefSummary': 'Introduction:\n\nThe frequency of fetuses in occiput posterior position during labor is approximately 20 %, in which 5% remain occiput posterior at the end of labor. Occiput posterior position is associated with higher risks of caesarean deliveries and operative vaginal deliveries. The manual rotation to promote rotation from a posterior to an anterior position has been proposed to reduce the extraction rate. There is no randomised trial comparing the effect of manual rotation and expectant management. We propose a protocol for a prospective, monocentric, randomised controlled clinical trial in order to show that the rate of spontaneous vaginal delivery is higher with manual rotation of occiput posterior position than with an expectative management.\n\nMethods:\n\nEvery 37 weeks with a singleton pregnancy with a clinical occiput posterior position suspicion confirmed by a transabdominal ultrasound at full dilatation will be eligible. Participants will be randomised to either prophylactic manual rotation (experimental group) or expectative management (control group). Based on an alpha value of 0.05 and gaining 20% for spontaneous vaginal delivery, 238 participants will need to be enrolled.\n\nThe primary outcome will be spontaneous vaginal delivery. Secondary outcomes will be operative delivery rate (caesarean section , vacuum or forceps deliveries), significant maternal and perinatal mortality/morbidity.\n\nAnalysis will be by intention-to-treat averaging a 24-month period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '1. Inclusion Criteria:\n\n * age ≥ 18 years\n * singleton pregnancy\n\n -≥37 weeks of gestation\n * planned vaginal birth\n * cephalic presentation\n * occiput posterior position confirmed by ultrasound at full dilatation\n2. Exclusion Criteria:\n\n * withdrawal of consent'}, 'identificationModule': {'nctId': 'NCT03009435', 'acronym': 'RMOS', 'briefTitle': 'RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate (RMOS)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate', 'orgStudyIdInfo': {'id': '2016-A01456-45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'prophylactic manual rotation', 'description': 'Only obstetricians will participate in the study. Manual rotation is performed at full dilatation.The technique employed will be at the discretion of the operator performing the procedure :\n\n* Tarnier and Chantreuil technique\n* or SOGC technique', 'interventionNames': ['Other: prophylactic manual rotation']}, {'type': 'NO_INTERVENTION', 'label': 'expectative management', 'description': 'Expectative management . No manual rotation'}], 'interventions': [{'name': 'prophylactic manual rotation', 'type': 'OTHER', 'armGroupLabels': ['prophylactic manual rotation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Caroline Verhaeghe', 'role': 'CONTACT', 'email': 'verhaeghe.caroline@gmail.com', 'phone': '+3364184459'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}