Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT04307069
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2020-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management of Prelabor Rupture of the Membranes at Term
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002821', 'term': 'Chorioamnionitis'}, {'id': 'D004716', 'term': 'Endometritis'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005322', 'term': 'Fetal Membranes, Premature Rupture'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D010922', 'term': 'Placenta Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000292', 'term': 'Pelvic Inflammatory Disease'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 524}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-11', 'studyFirstSubmitDate': '2020-03-11', 'studyFirstSubmitQcDate': '2020-03-11', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal infectious morbidity', 'timeFrame': 'Up to 48 hours postpartum', 'description': 'Maternal chorioamnionitis and/ or endometritis'}], 'secondaryOutcomes': [{'measure': 'Length of latent and active phases of labor.', 'timeFrame': 'During Labor', 'description': 'According to vaginal examinations during labor'}, {'measure': 'Adverse maternal outcome', 'timeFrame': 'Up to 48 hours postpartum', 'description': 'infectious (chorioamnionitis/endometritis), serious maternal morbidity and mortality (death, cardiac arrest, respiratory arrest, ICU admission), post-partum hemorrhage (PPH), obstetric anal sphincter injuries (OASIS).'}, {'measure': 'Adverse neonatal outcome', 'timeFrame': 'Up to 48 hours postpartum', 'description': 'stillbirth, infectious disease (sepsis, meningitis, pneumonia), 5-minute Apgar score \\< 7, umbilical artery pH \\< 7.0, NICU admission, RDS, use of mechanical ventilation, NEC.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fetal Infection', 'Chorioamnionitis', 'Endometritis', 'Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'Prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. In this study the investigators will investigate whether an early intervention to augment labor with oxytocin is superior to expected management for spontaneous delivery (up to 24 hours).', 'detailedDescription': 'Prelabor rupture of the membranes (PROM) refers to rupture of the fetal membranes prior to the onset of regular uterine contractions.\n\nPROM at term can be managed actively by induction of labor or expectantly by waiting for the onset of a spontaneous labor. Several studies have shown an association between expectant management and higher rates of maternal and neonatal adverse outcomes, especially infections. Furthermore, expectant management has been shown to increase the risk for cesarean deliveries (CD), chronic lung disease, cerebral palsy and neonatal mortality. It is suggested that the risk for those complications increase proportionally with the longer the duration of ruptured membranes. Others disagree with those associations.\n\nIn this study the investigators will investigate whether early administration of oxytocin is superior to expectant management of 24 hours in patients with PROM at term, in terms of time to delivery and maternal and neonatal adverse outcomes, regardless of bishop score.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes.\n2. Women at gestational age 370/7 or more.\n3. Vertex presentation.\n\nExclusion Criteria:\n\n1. Age 18 and under.\n2. High order gestation.\n3. Women with contraindication for a vaginal delivery.\n4. Active labor.\n5. Documented fetal anomalies.\n6. Known or suspected intrauterine infection (temperature \\> 38 degrees, leucocytosis).\n7. Non reassuring fetal heart rate tracing.\n8. Positive group B streptococcus status.'}, 'identificationModule': {'nctId': 'NCT04307069', 'briefTitle': 'Management of Prelabor Rupture of the Membranes at Term', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Comparison Between Two Protocols for Management of Prelabor Rupture of the Membranes at Term', 'orgStudyIdInfo': {'id': 'Rambam Health-Care Center'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate oxytocin infusion', 'description': 'Once the patient will arrive at the maternity ward with prelabor rupture of membranes, she will receive oxytocin for augmentation of labor.', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'EXPERIMENTAL', 'label': 'Expectant management for 24 hours', 'description': 'Once the patient will arrive at the maternity ward with prelabor rupture of membranes, we will wait for spontaneous delivery to occur. After 24 hours of rupture of membranes, the woman will receive oxytocin for augmentation of labor.', 'interventionNames': ['Drug: Oxytocin']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'otherNames': ['pitocin'], 'description': 'The drug wil be adminisrate for augmentation of labor at admission.', 'armGroupLabels': ['Expectant management for 24 hours', 'Immediate oxytocin infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3009500', 'city': 'Ramat Yishai', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Gal Bachar', 'role': 'CONTACT', 'phone': '0524858699'}], 'facility': 'Rambam', 'geoPoint': {'lat': 32.70444, 'lon': 35.1707}}], 'centralContacts': [{'name': 'Gal Bachar, MD', 'role': 'CONTACT', 'email': 'gal.bachar13@gmail.com', 'phone': '+972524858699'}], 'overallOfficials': [{'name': 'Gal Bachar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Medical Health Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}