Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-01 @ 2:17 AM
Study NCT ID:
NCT05040334
Status:
UNKNOWN
Last Update Posted:
2022-03-28
First Post:
2021-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '138 identical envelops, half of them filled with a label(Group 1) who are the "Prophylactic antibiotic" group with all instruction details, while the other half are labelled (group 2) who are the "Placebo" group with all instruction details. All envelops will be prepared by the investigator and sealed before starting enrollment. After enrollment, each participant will be allowed to choose one envelop to determine to which group she will be assigned.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group 1;receiving antibiotic prophylaxis Group 2; Not receiving antibiotics'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 138}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2021-08-14', 'studyFirstSubmitQcDate': '2021-09-03', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of pelvic infection after surg ical evacuation of miscarriage with use of antibiotic prophylaxis.', 'timeFrame': '2 weeks from surgery', 'description': 'White cell count \\>12 \\*10\\^9 cells / L by CBC'}], 'secondaryOutcomes': [{'measure': 'Change in the risk of severe puerperal sepsis following the surgical procedure', 'timeFrame': '2 weeks from surgery', 'description': 'Signs of puerperal sepsis in form of puerperal pyrexia \\>38 C and/or purulent vaginal discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Antibiotics Causing Adverse Effects in Therapeutic Use']}, 'descriptionModule': {'briefSummary': 'To determine the role of antibiotic prophylaxis in the surgical management of miscarriage.', 'detailedDescription': 'Patients will be randomized to receive either prophylactic antibiotic \\[a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)\\] or placebo using identical sealed envelopes.Included cases are those with early miscarriage (within the first trimester 12 6/7 weeks of gestation) , missed or incomplete miscarriage, undergoing surgical management will be included in the study.\n\nTechnique:\n\nThe investigators will prepare 138 identical envelops, half of them filled with a label group(1) who are the group to receive the antibiotic prophylaxis with all instruction details, while the other half filled with a label identifying ( group 2) who are the placebo group. All envelops will be prepared by the investigator and sealed before starting enrollment. After enrollment, each participant will be allowed to choose one envelop to determine to which group the patient will be assigned to.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Maternal age :18-35 years\n* Gestational age: up to 12 6/7 weeks of gestation (confirmed by a reliable date for the last menstrual period or /and 1st trimester ultrasound scan).\n* Singleton miscarriage\n* Type of miscarriage: Incomplete or Missed miscarriage\n* Surgical evacuation will be done within 2 weeks of diagnosis of miscarriage .\n\nExclusion criteria:\n\n* Maternal age: younger than 18 years\n* Induced miscarriage of pregnancy\n* Septic miscarriage\n* Evidence of infection\n* Morbid obesity (BMI≥40kg/m2)\n* Allergy to prophylactic antibiotics (i.e., doxycycline or metronidazole)\n* Antibiotics use within 7 days before randomization'}, 'identificationModule': {'nctId': 'NCT05040334', 'briefTitle': 'Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation', 'orgStudyIdInfo': {'id': 'Cairo University Obygyn'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group(1)', 'description': '69 patients receiving a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)tablets', 'interventionNames': ['Drug: Group 1: Antibiotic receiving group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group (2)', 'description': '69 patients receiving placebo', 'interventionNames': ['Drug: Group 1: Antibiotic receiving group']}], 'interventions': [{'name': 'Group 1: Antibiotic receiving group', 'type': 'DRUG', 'otherNames': ['Group 2 :placebo receiving group'], 'description': 'Group 1; receiving antibiotic prophylaxis; single dose of oral doxycycline (200 mg) tablet and metronidazole (500 mg) tablet 2 hours before the surgical evacuation Group B ;receiving placebo 2 hours before the surgical evacuation', 'armGroupLabels': ['Group (2)', 'group(1)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Marwa Mo Eid, Ass prof', 'role': 'CONTACT', 'email': 'marwameid2014@gmail.com', 'phone': '01001225079'}, {'name': 'Nihal Mo El-Demiry, Lecturer', 'role': 'CONTACT', 'email': 'n.eldemiry@gmail.com', 'phone': ': 01006049052'}], 'facility': 'Department of Obstetrics and Gynecology, Kasr Al-Ainy University Hospital, Cairo University.', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Marwa Mo Eid, Ass.professor', 'role': 'CONTACT', 'email': 'marwameid2014@gmail.com', 'phone': '01001225079'}, {'name': 'Nihal Mo El-Demiry, Lecturer', 'role': 'CONTACT', 'email': 'n.eldemiry@gmail.com', 'phone': '01006049052'}], 'overallOfficials': [{'name': 'Marwa Mo Eid, Ass.prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Nihal Mo El-Demiry, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Marwa Mohamed Mahmoud Eid', 'investigatorAffiliation': 'Cairo University'}}}}