Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-03-25 @ 5:46 AM
Study NCT ID:
NCT02131818
Status:
TERMINATED
Last Update Posted:
2015-12-03
First Post:
2014-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Necessity of Antibiotics for Prevention of Delivery-associated Infections After Spontaneous Vaginal Delivery at Term
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011645', 'term': 'Puerperal Infection'}], 'ancestors': [{'id': 'D011251', 'term': 'Pregnancy Complications, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'The enrollment process is too difficult to complete', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2014-04-28', 'studyFirstSubmitQcDate': '2014-05-04', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of perineal wound infection', 'timeFrame': 'within 6 weeks after normal labor', 'description': 'Follow up perineal wound every day during admission and follow up 6 weeks after discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['amoxicillin', 'postpartum infections', 'puerperal infection'], 'conditions': ['Perineal Wound Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine amoxicillin is effective in the prevention of wound infection in normal labor.', 'detailedDescription': "When the pregnant women is admitted due to first stage of labor , the investigator will inform the patients. If the patients give consent, the patient's data will be collect in case record form. the patients will be swab at posterior fornix and around anus to collect specimen and send to microbiology lab before per vaginal examination. After the patients finish in labor, perineal wound will be swab to collect specimen and send to microbiology lab. Then the patients are randomized in two group, the first one will receive amoxicillin and the second one will receive placebo. During admission the patients will be exam by investigator every day. After the patients are discharge, the follow up will be appoint on 6 weeks later. The infant will be swab at rectum to collect specimen and send to microbiology lab when the patient's discharge day. Every specimen will be culture for bacteria and perform antimicrobial susceptibility test for amoxicillin."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term pregnancy\n* Normal labor\n\nExclusion Criteria:\n\n* Penicillin allergy\n* Previous history antibiotic using within 2 weeks\n* Patients cannot take oral medication\n* Patients have underlying disease eg. diabetes mellitus, hypertension, HIV infection\n* Premature rupture of membranes'}, 'identificationModule': {'nctId': 'NCT02131818', 'briefTitle': 'Necessity of Antibiotics for Prevention of Delivery-associated Infections After Spontaneous Vaginal Delivery at Term', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Necessity of Antibiotics for Prevention of Delivery-associated Infections After Spontaneous Vaginal Delivery at Term', 'orgStudyIdInfo': {'id': 'SI-OBG-CEU-01-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amoxicillin', 'description': 'The patient will be received amoxicillin 500 mg 2 capsules orally bid pc for 5 days', 'interventionNames': ['Drug: Amoxicillin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The patient will be received placebo 2 capsules orally bid pc for 5 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Amoxicillin', 'type': 'DRUG', 'otherNames': ['Drug A', 'Drug B'], 'description': 'The patient will be received amoxicillin 500 mg 2 capsules orally bid pc for 5 days', 'armGroupLabels': ['Amoxicillin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Drug A', 'Drug B'], 'description': 'The patient will be received placebo 2 capsules orally bid pc for 5 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine Siriraj Hoapital Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Vitaya Titapant, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}