Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-28 @ 2:58 AM
Study NCT ID:
NCT06735703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-16
First Post:
2024-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Group B Streptococcus Infection and PROM Incidince
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005322', 'term': 'Fetal Membranes, Premature Rupture'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-01-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2024-12-11', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidince of prom with GBS infection and prophylaxis against it', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Rupture of Fetal Membranes', 'Group B Streptococcal Infection']}, 'descriptionModule': {'briefSummary': 'To investigate incidince of prom with GBS infection and role of prophylaxis against it'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women with prom', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women with prom after 34 wks festation\n\nExclusion Criteria:\n\n* Bleeding disorder\n* emergency conditions'}, 'identificationModule': {'nctId': 'NCT06735703', 'briefTitle': 'Group B Streptococcus Infection and PROM Incidince', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Incidince of PROM with GBS Infection and Prophylaxis Against It', 'orgStudyIdInfo': {'id': 'GBS WITH PROM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant women after 34 wks with PROM', 'interventionNames': ['Drug: To provide ampicillin sulbactam to pregnant women with premature rupture of membrane']}], 'interventions': [{'name': 'To provide ampicillin sulbactam to pregnant women with premature rupture of membrane', 'type': 'DRUG', 'description': 'To provide ampicillin sulbactam tonpregnant women with premature rupture of membrane after 34 wks gestation', 'armGroupLabels': ['Pregnant women after 34 wks with PROM']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dina Mohamed Kamel', 'role': 'CONTACT', 'email': 'dinakamel802@gmail.com', 'phone': '0927923623'}, {'name': 'Sherif Abdelmeged badran', 'role': 'CONTACT', 'phone': '0927923623'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dina mohamedkamel', 'investigatorFullName': 'Dina Mohamed Kamel', 'investigatorAffiliation': 'Assiut University'}}}}