Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-30 @ 12:06 AM
Study NCT ID:
NCT00331695
Status:
COMPLETED
Last Update Posted:
2011-05-09
First Post:
2006-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 560}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-06', 'studyFirstSubmitDate': '2006-05-30', 'studyFirstSubmitQcDate': '2006-05-30', 'lastUpdatePostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interval between inclusion and delivery.', 'timeFrame': 'during de study', 'description': 'Interval between inclusion and delivery.'}], 'secondaryOutcomes': [{'measure': 'Preterm delivery rate < 37 W, < 34 W et < 32 W,', 'timeFrame': 'during the study', 'description': 'Preterm delivery rate \\< 37 W, \\< 34 W et \\< 32 W,'}, {'measure': 'Number of hospitalizations for preterm labor,', 'timeFrame': 'during the study', 'description': 'Number of hospitalizations for preterm labor,'}, {'measure': 'Cerclage performed at or after 20 weeks,', 'timeFrame': 'during the study', 'description': 'Cerclage performed at or after 20 weeks,'}, {'measure': 'Neonatal weight,', 'timeFrame': 'during the study', 'description': 'Neonatal weight,'}, {'measure': 'NICU transport', 'timeFrame': 'during the study', 'description': 'NICU transport'}, {'measure': 'Respiratory distress syndrome,', 'timeFrame': 'during the study', 'description': 'Respiratory distress syndrome,'}, {'measure': 'Bronchopulmonary dysplasia,', 'timeFrame': 'during the study', 'description': 'Bronchopulmonary dysplasia,'}, {'measure': 'Necrotizing enterocolitis,', 'timeFrame': 'during the study', 'description': 'Necrotizing enterocolitis,'}, {'measure': 'leucomalacia,', 'timeFrame': 'during the study', 'description': 'leucomalacia,'}, {'measure': 'neonatal death.', 'timeFrame': 'during the study', 'description': 'neonatal death.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Progesterone', 'Preterm delivery', 'Preterm labor', 'Cervical length', 'ultrasonography'], 'conditions': ['Preterm Delivery']}, 'referencesModule': {'references': [{'pmid': '15516390', 'type': 'BACKGROUND', 'citation': 'Rozenberg P, Rudant J, Chevret S, Boulogne AI, Ville Y. Repeat measurement of cervical length after successful tocolysis. Obstet Gynecol. 2004 Nov;104(5 Pt 1):995-9. doi: 10.1097/01.AOG.0000143254.27255.e9.'}, {'pmid': '25448515', 'type': 'DERIVED', 'citation': 'Winer N, Bretelle F, Senat MV, Bohec C, Deruelle P, Perrotin F, Connan L, Vayssiere C, Langer B, Capelle M, Azimi S, Porcher R, Rozenberg P; Groupe de Recherche en Obstetrique et Gynecologie. 17 alpha-hydroxyprogesterone caproate does not prolong pregnancy or reduce the rate of preterm birth in women at high risk for preterm delivery and a short cervix: a randomized controlled trial. Am J Obstet Gynecol. 2015 Apr;212(4):485.e1-485.e10. doi: 10.1016/j.ajog.2014.10.1097. Epub 2014 Oct 30.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate that the intramuscular administration of 17 alpha hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length egal and inferiority 26 mm between 20 and 32 weeks of gestation and:\n\n* either a first episode of preterm labor stopped by acute tocolysis;\n* either a history of late miscarriage or premature delivery or uterine malformation or DES\n* either a twin pregnancy. Therefore, a randomised, multicentre trial has been designed with initial stratification according to these three risk groups, opened with two parallel arms.', 'detailedDescription': 'Objective\n\nTo demonstrate that the intramuscular administration of 17 alpha - hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length 26 mm between 20 and 32 weeks of gestation and:\n\n* either a first episode of preterm labor stopped by acute tocolysis;\n* either a history of late miscarriage or premature delivery or uterine malformation or DES\n* either a twin pregnancy. Experimental design Prospective, randomized, multicenter, trial with initial stratification according to three risk groups, opened with two parallel arms.\n\nThe maximal duration for treatment will be 16 weeks for each included patient. The duration for inclusions will be 30 months. The duration for participation of each patient will be 10 to 22 weeks. The foreseen inclusion period for this trial is from 06/01/2006 to 12/31/2008 Description Two therapeutic strategies will be compared in each risk group and attributed by uniform randomisation.\n\nArm A :IM injection of 17 alpha hydroxyprogesterones caproate, 500 mg, twice a week until 36 W or until preterm delivery in high risk symptomatic group and high risk twin pregnancies group.\n\nIM injection of 17 alpha-hydroxyprogesterones caproate, 500 mg, once a week until 36 W or until preterm delivery in high risk asymptomatic group.\n\nArm B :No treatment with 17 alpha-hydroxyprogesterones caproate. (usual management) Presentation : Progesterone retard Pharlon 500 mg Tolerance criteria\n\n* nausea,vomiting,\n* weakness'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ultrasonographic cervical length 26 mm between 20 and 32 weeks of gestation and:\n* either a first episode of preterm labor stopped by acute tocolysis\n* either a history of late miscarriage or premature delivery or uterine malformation or DES;\n* either a twin pregnancy.\n\nExclusion Criteria:\n\n* cervical dilatation \\> 3 cm,\n* chorioamnionitis,\n* fetal distress,\n* placenta praevia,\n* abruptio placenta,\n* preterm premature rupture of membranes,\n* polyhydramnios,\n* Twin-twin transfusion syndrome,\n* IUGR,\n* preeclampsia or hypertension,\n* other pathology justifying a preterm delivery,\n* epilepsy drugs\n* participation to another therapeutic trial,\n* any patient for whom informed consent cannot be obtained.'}, 'identificationModule': {'nctId': 'NCT00331695', 'briefTitle': 'Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation of the Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery', 'orgStudyIdInfo': {'id': 'P040438'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '17 alpha-hydroxyprogesterones caproate', 'interventionNames': ['Drug: 17 alpha-hydroxyprogesterones caproate']}], 'interventions': [{'name': '17 alpha-hydroxyprogesterones caproate', 'type': 'DRUG', 'description': '17 alpha-hydroxyprogesterones caproate', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78303', 'city': 'Poissy', 'country': 'France', 'facility': 'CHI Poissy st Germain', 'geoPoint': {'lat': 48.92902, 'lon': 2.04952}}, {'zip': '78', 'city': 'Poissy', 'country': 'France', 'facility': 'Chi Poissy St Germain', 'geoPoint': {'lat': 48.92902, 'lon': 2.04952}}], 'overallOfficials': [{'name': 'Patrick ROZENBERG, MD,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Christophe AUCAN', 'oldOrganization': 'Department of Clinical Research of developpement'}}}}