Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-27 @ 10:25 AM
Study NCT ID:
NCT01945450
Status:
UNKNOWN
Last Update Posted:
2013-11-27
First Post:
2013-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004716', 'term': 'Endometritis'}], 'ancestors': [{'id': 'D000292', 'term': 'Pelvic Inflammatory Disease'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019072', 'term': 'Antibiotic Prophylaxis'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D005839', 'term': 'Gentamicins'}, {'id': 'D002981', 'term': 'Clindamycin'}], 'ancestors': [{'id': 'D018890', 'term': 'Chemoprevention'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011292', 'term': 'Premedication'}, {'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'}, {'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'lastUpdateSubmitDate': '2013-11-26', 'studyFirstSubmitDate': '2013-09-15', 'studyFirstSubmitQcDate': '2013-09-17', 'lastUpdatePostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endometritis rate', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Puerperal fever', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Endometritis']}, 'descriptionModule': {'briefSummary': 'Background: There is scarce evidence regarding the necessity of antibiotic prophylaxis in manual revision of the uterus after labor in cases of residual placenta.\n\nMethods: a randomized control trial in which parturients for which the placenta was not separated or there is a suspected residual placenta will be divided randomly to two groups: (1) Revision of uterus or Manual lysis without antibiotic prophylaxis; (2) Revision of uterus or Manual lysis with antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams\\*4, Gentamycin 240 mg\\*1, Clindamycin 600 mg\\*3. In cases of allergy to Penicillin the antibiotic regimen will be: Gentamycin 240 mg\\*1, Clindamycin 600 mg\\*3.\n\nOutcomes: Puerperal fever, endometritis, length of hospitalization after labor, recurrent hospitalization in the first 2 weeks after discharge.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suspected retained placenta\n\nExclusion Criteria:\n\n* Intrapartum fever'}, 'identificationModule': {'nctId': 'NCT01945450', 'briefTitle': 'Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth', 'orgStudyIdInfo': {'id': '0186-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Antibiotic prophylaxis', 'description': 'antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams\\*4, Gentamycin 240 mg\\*1, Clindamycin 600 mg\\*3', 'interventionNames': ['Drug: Antibiotic prophylaxis', 'Drug: Ampicillin', 'Drug: Gentamycin', 'Drug: Clindamycin']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment', 'description': 'No antibiotics'}], 'interventions': [{'name': 'Antibiotic prophylaxis', 'type': 'DRUG', 'description': 'antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams\\*4, Gentamycin 240 mg\\*1, Clindamycin 600 mg\\*3', 'armGroupLabels': ['Antibiotic prophylaxis']}, {'name': 'Ampicillin', 'type': 'DRUG', 'armGroupLabels': ['Antibiotic prophylaxis']}, {'name': 'Gentamycin', 'type': 'DRUG', 'armGroupLabels': ['Antibiotic prophylaxis']}, {'name': 'Clindamycin', 'type': 'DRUG', 'armGroupLabels': ['Antibiotic prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Hadas Lamnerg, MD', 'role': 'CONTACT', 'email': 'lhadas@hadassah.org.il', 'phone': ': 00 972 2 6777572'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}