Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-02 @ 8:26 PM
Study NCT ID:
NCT07301957
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Early Rupture of the Residual Membrane on Latency Before Labour Begins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005322', 'term': 'Fetal Membranes, Premature Rupture'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Latency between the rupture of membranes and the onset of labour', 'timeFrame': 'At labour onset (up to 6 days)', 'description': "Latency is evaluated by the time in minutes between the rupture of membranes and the onset of labour. The diagnosis of rupture is the spontaneous loss of fluid through the vagina. The diagnosis of labour is defined by the onset of painful uterine contractions and cervical changes. The time recorded will be when the patient's cervix is 3 cm dilated."}], 'secondaryOutcomes': [{'measure': 'Trigger rate for prolonged rupture of membranes', 'timeFrame': '48 hours after rupture of membranes', 'description': "Trigger rate for prolonged rupture of membranes was evaluated by absence of spontaneous labour 48 hours after the time H0 defined during the initial consultation (rupture of membrane's diagnosis)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prelabor rupture of membranes'], 'conditions': ['Prelabor Rupture of Membranes']}, 'descriptionModule': {'briefSummary': 'Approximately 25% of patients experience premature rupture of membranes before labour. Of these patients, 82% will give birth within 24 hours and 97% within 48 hours.\n\nPatients who do not go into labour spontaneously will be induced 24 or 48 hours after their membranes rupture, depending on the centre.\n\nDuring this period, they are hospitalised in the obstetrics department. The presence of a residual membrane appears to prolong the latency period before labour begins and the rate of induction, according to a pilot study conducted by investigator.\n\nNo study specifically addresses this topic. The various studies on "Rupture of Membranes Before Labour" assess its frequency of occurrence or the time before considering induction. They also assess the occurrence of maternal-foetal infection. This is no longer of interest today, as antibiotic prophylaxis has significantly reduced maternal-foetal infections.\n\nInvestigator would therefore like to assess the impact of additional rupture of the residual membrane upon the patient\'s admission on the latency before labour and the induction rate (for membrane rupture exceeding 48 hours.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women over 18 years of age\n* Single foetal pregnancy, cephalic presentation\n* diagnosis of membrane rupture with persistence of one membrane and absence of immediate spontaneous labour.\n* Person affiliated with or beneficiary of a social security scheme\n* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).\n\nExclusion Criteria:\n\n* Minor patient\n* patient under guardianship/curatorship,\n* multiple pregnancy, pregnancy with foetal death\n* non-cephalic presentation\n* gestational age less than 37 weeks,\n* rupture of membranes more than 12 hours ago\n* contraindication to vaginal deliver\n* meconium-stained amniotic fluid,\n* clinical signs suggestive of intrauterine infection (maternal hyperthermia \\>38°C, maternal and/or foetal tachycardia, purulent amniotic fluid),\n* cervix not accessible for artificial rupture\n* vaginismus\n* contraindication to a potential expectant management\n* indication for induction for another reason'}, 'identificationModule': {'nctId': 'NCT07301957', 'acronym': 'RESIRUPT', 'briefTitle': 'Impact of Early Rupture of the Residual Membrane on Latency Before Labour Begins', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier le Mans'}, 'officialTitle': 'Impact of Early Rupture of the Residual Membrane on Latency Before Labour Begins', 'orgStudyIdInfo': {'id': 'CHM-2023/S30/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Additional rupture of the residual membrane', 'description': 'Rupture of the residual membrane', 'interventionNames': ['Other: Additional rupture of the residual membrane']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'unbroken residual membrane'}], 'interventions': [{'name': 'Additional rupture of the residual membrane', 'type': 'OTHER', 'description': 'Additional rupture of the residual membrane using a sterile, single-use amniotic membrane piercer such as the Robé device', 'armGroupLabels': ['Additional rupture of the residual membrane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'contacts': [{'name': 'Pierre-Emmanuel BOUET, MD', 'role': 'CONTACT', 'email': 'pierreemmanuel.bouet@chu-angers.fr', 'phone': '+33241354215'}, {'name': 'Pierre-Emmanuel BOUET, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '72000', 'city': 'Le Mans', 'country': 'France', 'contacts': [{'name': 'Christelle JADEAU', 'role': 'CONTACT', 'email': 'recherchecliniquepromotion@ch-lemans.fr', 'phone': '+33244710204'}, {'name': 'Marie-Charlotte FAURANT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}], 'centralContacts': [{'name': 'Christelle JADEAU', 'role': 'CONTACT', 'email': 'recherchecliniquepromotion@ch-lemans.fr', 'phone': '+33244710204'}], 'overallOfficials': [{'name': 'Marie-Charlotte FAURANT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier le Mans'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier le Mans', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}