Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT05342467
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2022-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gemeprost Versus Dinoprostone in First Trimester Miscarriages
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000030', 'term': 'Abortion, Missed'}, {'id': 'D000027', 'term': 'Abortion, Incomplete'}, {'id': 'D000022', 'term': 'Abortion, Spontaneous'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C021182', 'term': 'gemeprost'}, {'id': 'D013488', 'term': 'Suppositories'}, {'id': 'D015232', 'term': 'Dinoprostone'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011458', 'term': 'Prostaglandins E'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparison between intravaginal gemeprost and dinoprostone.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2022-04-17', 'studyFirstSubmitQcDate': '2022-04-17', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of women who achieved complete evacuation', 'timeFrame': 'from recruitment until up to one week after commencement of treatment', 'description': 'Complete expulsion of product of conception'}], 'secondaryOutcomes': [{'measure': 'Percentage of women who experienced side effects', 'timeFrame': 'from recruitment until up to one week after commencement of treatment', 'description': 'side effects towards each drug such as fever, gastrointestinal upset'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['miscarriages', 'first trimester', 'medical treatment'], 'conditions': ['Missed Abortion', 'Medical; Abortion, Fetus', 'Incomplete Abortion']}, 'descriptionModule': {'briefSummary': 'Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.', 'detailedDescription': 'Women who are diagnosed with first trimester missed miscarriages are invited to participate in the study. They will be randomised to either gemeprost or dinoprostone.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* missed miscarriages\n* incomplete miscarriages\n* first trimester\n\nExclusion Criteria:\n\n* coagulopathy\n* Rhesus negative\n* suspected ectopic pregnancy or pregnancy of unknown location\n* on anticoagulation drug\n* septic miscarriages\n* hemodynamically unstable'}, 'identificationModule': {'nctId': 'NCT05342467', 'briefTitle': 'Gemeprost Versus Dinoprostone in First Trimester Miscarriages', 'organization': {'class': 'OTHER', 'fullName': 'National University of Malaysia'}, 'officialTitle': 'Gemeprost Versus Dinoprostone in the Medical Management of First Trimester Miscarriages: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'FF-2021-504'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gemeprost', 'description': 'Gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours.', 'interventionNames': ['Drug: Gemeprost 1 Mg Vaginal Pessary', 'Drug: Dinoprostone 3 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dinoprostone', 'description': 'Dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours.', 'interventionNames': ['Drug: Gemeprost 1 Mg Vaginal Pessary', 'Drug: Dinoprostone 3 mg']}], 'interventions': [{'name': 'Gemeprost 1 Mg Vaginal Pessary', 'type': 'DRUG', 'description': 'Intravaginal gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours', 'armGroupLabels': ['Dinoprostone', 'Gemeprost']}, {'name': 'Dinoprostone 3 mg', 'type': 'DRUG', 'description': 'Intravaginal dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours', 'armGroupLabels': ['Dinoprostone', 'Gemeprost']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56000', 'city': 'Kuala Lumpur', 'state': 'W.Persekutuan', 'country': 'Malaysia', 'facility': 'UKM Medical Center', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '56000', 'city': 'Kuala Lumpur', 'state': 'W.Persekutuan', 'country': 'Malaysia', 'facility': 'UKM Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'overallOfficials': [{'name': 'Rahana Abd Rahman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of Malaysia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Yes'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}