Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-11 @ 3:19 PM
Study NCT ID:
NCT01633294
Status:
COMPLETED
Last Update Posted:
2016-11-28
First Post:
2012-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002821', 'term': 'Chorioamnionitis'}, {'id': 'D000071074', 'term': 'Neonatal Sepsis'}, {'id': 'D005322', 'term': 'Fetal Membranes, Premature Rupture'}, {'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': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D010922', 'term': 'Placenta Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D000667', 'term': 'Ampicillin'}, {'id': 'D005839', 'term': 'Gentamicins'}], 'ancestors': [{'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-24', 'studyFirstSubmitDate': '2012-06-23', 'studyFirstSubmitQcDate': '2012-06-30', 'lastUpdatePostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neonatal infection rate', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days', 'description': 'neonatal infection rate includes early onset sepsis, meningitis and pneumonia'}, {'measure': 'maternal infection rate', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days', 'description': 'maternal infection rate includes chorioamnionitis or puerperal endometritis'}], 'secondaryOutcomes': [{'measure': 'comparison of the infection rates between prompt and delayed induction', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 days', 'description': 'rate of maternal and neonatal infection between prompt (\\<12h) and delayed induction (≥12h) in the group of patients not submitted to antibiotic prophylaxis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['premature rupture of membranes', 'term pregnancy', 'chorioamnionitis', 'endometritis', 'neonatal sepsis', 'antibiotic prophylaxis'], 'conditions': ['Chorioamnionitis', 'Puerperal Endometritis', 'Neonatal Early Onset Sepsis', 'Neonatal Meningitis', 'Neonatal Pneumonia']}, 'referencesModule': {'references': [{'pmid': '23090521', 'type': 'DERIVED', 'citation': 'Passos F, Cardoso K, Coelho AM, Graca A, Clode N, Mendes da Graca L. Antibiotic prophylaxis in premature rupture of membranes at term: a randomized controlled trial. Obstet Gynecol. 2012 Nov;120(5):1045-51. doi: 10.1097/aog.0b013e31826e46bc.'}]}, 'descriptionModule': {'briefSummary': 'The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal infection and to compare these rates between prompt (\\< 12 hour) and delayed (≥ 12 hour) induction in the group of patients not submitted to antibiotic prophylaxis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* term (≥ 37+0 weeks) singleton pregnancy\n* a vertex presentation\n* ruptured membranes for less than 12 hours\n* negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks\n\nExclusion Criteria:\n\n* active labor\n* absence of GBS culture or indication for GBS antibiotic prophylaxis (such as maternal GBS colonization between 35 and 37 weeks, GBS bacteriuria, prior infant with GBS sepsis)\n* contraindication to expectant management (such as fetal distress, meconium staining of the amniotic fluid or chorioamnionitis) or to vaginal delivery'}, 'identificationModule': {'nctId': 'NCT01633294', 'briefTitle': 'Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Santa Maria, Portugal'}, 'officialTitle': 'Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '335/08 - 28/07/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Antibiotic group', 'description': 'women submitted to antibiotic prophylaxis', 'interventionNames': ['Drug: Ampicillin + gentamicin']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Ampicillin + gentamicin', 'type': 'DRUG', 'description': 'ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously', 'armGroupLabels': ['Antibiotic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital Santa Maria', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'overallOfficials': [{'name': 'Filipa Faria Vaz Passos, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Santa Maria Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Santa Maria, Portugal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Filipa Faria Vaz Passos', 'investigatorAffiliation': 'Hospital de Santa Maria, Portugal'}}}}