Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT00930618
Status:
COMPLETED
Last Update Posted:
2025-12-01
First Post:
2009-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reduction of Cesareans by Nitric Oxide (NO) Donors in Post Term Pregnancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011273', 'term': 'Pregnancy, Prolonged'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1409}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2009-06-29', 'studyFirstSubmitQcDate': '2009-06-29', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of cesarean sections', 'timeFrame': '10 days'}], 'secondaryOutcomes': [{'measure': 'Number of labor inductions', 'timeFrame': '10 days'}, {'measure': 'Number of spontaneous labors', 'timeFrame': '10 days'}, {'measure': 'Cesarean for failed labor induction', 'timeFrame': '10 days'}, {'measure': 'Cesarean for FHR abnormalities', 'timeFrame': '10 days'}, {'measure': 'Cesarean for arrested labor', 'timeFrame': '10 days'}, {'measure': 'Mean time between randomisation and spontaneous labor', 'timeFrame': '10 days'}, {'measure': 'Isosorbide mononitrate adverse effects', 'timeFrame': '10 days'}, {'measure': 'Maternal satisfaction', 'timeFrame': '10 days'}, {'measure': 'Neonatal morbidity', 'timeFrame': '10 days'}, {'measure': 'Mean time between randomisation and delivery', 'timeFrame': '10 days'}, {'measure': 'Mean duration of labor', 'timeFrame': '10 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prolonged pregnancy', 'Nulliparity', 'Cervical ripening', 'Induced labor', 'Cesarean section'], 'conditions': ['Prolonged Pregnancy', 'Nulliparity']}, 'referencesModule': {'references': [{'pmid': '25415159', 'type': 'RESULT', 'citation': 'Schmitz T, Fuchs F, Closset E, Rozenberg P, Winer N, Perrotin F, Verspyck E, Azria E, Carbonne B, Lepercq J, Maillard F, Goffinet F; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Outpatient cervical ripening by nitric oxide donors for prolonged pregnancy: a randomized controlled trial. Obstet Gynecol. 2014 Dec;124(6):1089-1097. doi: 10.1097/AOG.0000000000000544.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine whether cervical ripening with isosorbide mononitrate reduce caesarean section in women with post term pregnancies.', 'detailedDescription': 'The purpose of this trial is to determine whether cervical ripening with 40 mg of isosorbide mononitrate given intravaginally at 41+0, 41+2 and 41+4 weeks reduce cesarean section in nullipara with post term pregnancies. Treatments will be administered by midwifes in the maternity wards, women will be allowed to go back home in case of Bishop score\\<6. Otherwise labor will be induced with oxytocin. If undelivered at 41+5, women with Bishop score\\<6 will be induced with prostaglandins according to local protocols.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria :\n\n* Age \\> or = 18 years old\n* TAS \\> or = 95 mmHg\n* Singleton\n* Nulliparity\n* Term \\> or = 41 weeks + 0 day\n* Bishop score \\< or = 5\n* Vertex presentation\n* Intact membranes\n* No contra-indications of the study treatment\n* No maternal or fetal diseases which could indicate immediate labor induction\n* Written informed consent\n\nExclusion criteria :\n\n* Multiple pregnancy\n* Multiparity\n* Term \\< 41 weeks\n* Bishop score \\> 5\n* Breech presentation\n* Rupture of the membranes\n* Previous cesarean\n* Indication to immediate labor induction\n* Contraindications to isosorbide mononitrate\n* No co-administration of antihypertensive drugs\n* No social security'}, 'identificationModule': {'nctId': 'NCT00930618', 'acronym': 'NOCETER', 'briefTitle': 'Reduction of Cesareans by Nitric Oxide (NO) Donors in Post Term Pregnancies', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'NOCETER, a Multicenter Double Blind Placebo-controlled Randomized Trial: Reduction of CEsareans in Post TERm Pregnancies: Impact of Outpatient Cervical Ripening With NO Donors', 'orgStudyIdInfo': {'id': 'P071212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMN', 'description': 'Isosorbide mononitrate', 'interventionNames': ['Drug: IMN']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administration of placebo of IMN', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'IMN', 'type': 'DRUG', 'description': 'Administration of 2 x 20 mg of isosorbide mononitrate at each administration with a maximum of three administrations', 'armGroupLabels': ['IMN']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administration of 2 X 20 mg of placebo of IMN at each administration with a maximum of three administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Robert Debré Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'François Goffinet, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Scientific Responsible'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}