Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT02633761
Status:
TERMINATED
Last Update Posted:
2019-02-11
First Post:
2015-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mifepristone-misoprostol vs. Misoprostol Alone for Second Trimester Fetal Death
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005313', 'term': 'Fetal Death'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015735', 'term': 'Mifepristone'}, {'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-07', 'studyFirstSubmitDate': '2015-12-08', 'studyFirstSubmitQcDate': '2015-12-14', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete uterine evacuation of the fetus and placenta without surgical intervention', 'timeFrame': '48 hours', 'description': 'Complete uterine evacuation of fetus and placenta using study drug alone without recourse to any additional surgical intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fetal death', 'mifepristone', 'misoprostol'], 'conditions': ['Fetal Death']}, 'descriptionModule': {'briefSummary': 'The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP.', 'detailedDescription': 'The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP. This will be a randomized controlled double-blinded trial of 150 women comparing misoprostol alone to mifepristone plus misoprostol for evacuation of the uterus after fetal demise in the second and third trimester. All women in the trial will undergo routine screening and pre-medical induction care per standard practice at the hospital.\n\nAll eligible women agreeing to participate in the study will be randomized to receive one of the following regimens:\n\n1. STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours;\n2. STUDY GROUP TWO: placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Demised fetus of between 14 to 28 weeks duration confirmed by ultrasound\n* Have no contraindications to study procedure, according to provider\n* Be able to consent to procedure, either by reading consent document or by having consent document read to her\n* Be willing to follow study procedures.\n\nExclusion Criteria:\n\n* Allergies or other contraindications to the use of mifepristone or misoprostol;\n* Placental abruption with active hemorrhage,\n* Complete placenta previa, extreme uterine structural anomalies, or other contradictions to vaginal delivery of the fetus;\n* Presentation in active labor (moderate to severe contractions every 10 minutes or less);\n* Transmural uterine scars;\n* Four or more previous deliveries.'}, 'identificationModule': {'nctId': 'NCT02633761', 'briefTitle': 'Mifepristone-misoprostol vs. Misoprostol Alone for Second Trimester Fetal Death', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Mifepristone and Misoprostol Versus Misoprostol Alone for Treatment of Fetal Death at 14-28 Weeks of Pregnancy: A Randomized, Placebo-controlled Double-blinded Trial', 'orgStudyIdInfo': {'id': '1019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': '200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours', 'interventionNames': ['Drug: Mifepristone', 'Drug: Misoprostol 200mcg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2', 'description': 'placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.', 'interventionNames': ['Drug: Placebo', 'Drug: Misoprostol 200mcg']}], 'interventions': [{'name': 'Mifepristone', 'type': 'DRUG', 'description': '200mg mifepristone followed in 24 hours by 200mcg buccal misoprostol every 3 hours.', 'armGroupLabels': ['Group 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo followed in 24 hours by 200mcg buccal misoprostol every 3 hours.', 'armGroupLabels': ['Group 2']}, {'name': 'Misoprostol 200mcg', 'type': 'DRUG', 'description': 'Buccal misoprostol 200mcg', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Hospital General "Enrique Cabrera"', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': 'National Institute of Perinatology (INPer)', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'National Ob-Gyn Hospital', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'overallOfficials': [{'name': 'Hillary Bracken, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}