Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-26 @ 7:41 PM
Study NCT ID:
NCT06917157
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-08
First Post:
2025-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Latency Antibiotics for Previable Rupture Of Membranes Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants that delivered their babies after membrane rupture', 'timeFrame': 'from baseline to day 7'}], 'secondaryOutcomes': [{'measure': 'Latency, defined as the duration between rupture of membranes and delivery', 'timeFrame': 'from rupture of membranes to delivery(about 1-126 days after baseline)'}, {'measure': 'Number of participants that have Chorioamnionitis', 'timeFrame': 'Baseline upto delivery (about 1-126 days after baseline)'}, {'measure': 'Number of participants that develop sepsis', 'timeFrame': 'From baseline upto discharge (about 1-4 days post delivery)'}, {'measure': 'Number of maternal deaths', 'timeFrame': 'From baseline upto discharge (about 1-4 days post delivery)'}, {'measure': 'Number of admissions to intensive care unit (ICU)', 'timeFrame': 'From baseline upto discharge (about 1-4 days post delivery)'}, {'measure': 'Number of participants that develop postpartum hemorrhage', 'timeFrame': 'From baseline upto discharge (about 1-4 days post delivery)', 'description': 'postpartum hemorrhage could occur during the following:\n\n1. Transfusion\n2. Non-elective hysterectomy\n3. Use of two or more uterotonics other than oxytocin\n4. Other surgical interventions such as uterine compression sutures, uterine artery ligation, embolization and hypogastric ligation, balloon tamponade\n5. Curettage'}, {'measure': 'Number of participants that develop maternal postpartum infection', 'timeFrame': 'within 6 weeks of delivery', 'description': 'Infection is defined as one of the following:\n\n* Clinical diagnosis of endometritis\n* Wound reopened for hematoma, seroma, infection or other reasons\n* Cellulitis requiring antibiotics\n* Pneumonia\n* Pyelonephritis\n* Bacteremia unknown source\n* Septic pelvic thrombosis'}, {'measure': 'Number of participants that develop maternal venous thromboembolism', 'timeFrame': 'within 6 weeks of delivery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prophylactic antibiotics', 'neonatal morbidity'], 'conditions': ['Preterm Prelabor Rupture of Membranes (PPROM)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if the use of prophylactic antibiotics in the expectant management of PPROM less than 22 weeks significantly reduce the rate of delivery within 7 days and to see if the use of prophylactic antibiotics in the expectant management of PPROM between 20 and 22 weeks decrease composite neonatal morbidity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm premature rupture of membranes at less than 22 weeks.\n* Membrane rupture had occurred within 36 hours of randomization.\n* Cervical dilatation is 3 cm or less (on visual or clinical examination).\n* 4 or fewer contractions in the 60-minute monitoring period before randomization.\n* Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age\n* Gestational age at randomization less than 22 weeks (≤21 weeks and 6 days) based on clinical information.\n\nExclusion Criteria:\n\n* Nonreasoning fetal testing\n* Vaginal bleeding\n* Maternal or fetal indication for immediate delivery\n* Cervical cerclage in place\n* Receipt of latency antibiotics prior to randomization (azithromycin, ampicillin, or amoxicillin)\n* Allergy to Penicillins or Azithromycin\n* Febrile illness requiring antibiotics\n* Placenta previa\n* Multifetal gestation'}, 'identificationModule': {'nctId': 'NCT06917157', 'acronym': 'LAPROM', 'briefTitle': 'Latency Antibiotics for Previable Rupture Of Membranes Trial', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Latency Antibiotics for Previable Rupture Of Membranes: LAPROM Trial', 'orgStudyIdInfo': {'id': 'HSC-MS-24-1285'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Administration of antibiotics prophylactically at the time of membrane rupture', 'description': 'Membrane rupture per inclusion criteria will be less than 22 weeks', 'interventionNames': ['Drug: Administration of antibiotics prophylactically at the time of membrane rupture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Administration of antibiotics non-prophylactically at 22 weeks', 'interventionNames': ['Drug: Administration of antibiotics non-prophylactically at 22 weeks']}], 'interventions': [{'name': 'Administration of antibiotics prophylactically at the time of membrane rupture', 'type': 'DRUG', 'description': 'Participants will receive the antibiotic regimen:\n\n* Day 1: Oral Azithromycin 1 g once and intravenous Ampicillin 2 g every 6 hours\n* Day 2: Intravenous Ampicillin 2 g every 6 hours\n* Days 3-7: Oral Amoxicillin 500 mg every 8 hours', 'armGroupLabels': ['Administration of antibiotics prophylactically at the time of membrane rupture']}, {'name': 'Administration of antibiotics non-prophylactically at 22 weeks', 'type': 'DRUG', 'description': 'Participants will receive latency antibiotics starting 22 weeks 0 days:\n\n* Day 1: Oral Azithromycin 1 g once and intravenous Ampicillin 2 g every 6 hours\n* Day 2: Intravenous Ampicillin 2 g every 6 hours\n* Days 3-7: Oral Amoxicillin 500 mg every 8 hours', 'armGroupLabels': ['Administration of antibiotics non-prophylactically at 22 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Khalil Chahine, MD', 'role': 'CONTACT', 'email': 'Khalil.Chahine@uth.tmc.edu', 'phone': '(713) 500-6412'}, {'name': 'Baha Sibai', 'role': 'CONTACT', 'email': 'Baha.M.Sibai@uth.tmc.edu', 'phone': '(713) 500-6421'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Khalil Chahine, MD', 'role': 'CONTACT', 'email': 'Khalil.Chahine@uth.tmc.edu', 'phone': '(713) 500-6412'}, {'name': 'Baha Sibai', 'role': 'CONTACT', 'email': 'Baha.M.Sibai@uth.tmc.edu', 'phone': '(713) 500-6421'}], 'overallOfficials': [{'name': 'Khalil Chahine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'House Staff', 'investigatorFullName': 'Khalil Chahine', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}