Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-03 @ 2:20 AM
Study NCT ID:
NCT02342002
Status:
TERMINATED
Last Update Posted:
2019-01-15
First Post:
2015-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000030', 'term': 'Abortion, Missed'}], 'ancestors': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 416}}, 'statusModule': {'whyStopped': 'lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-11', 'studyFirstSubmitDate': '2015-01-09', 'studyFirstSubmitQcDate': '2015-01-14', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of successful evacuation of the uterus', 'timeFrame': '1 week after treatment', 'description': 'uterine evacuation without the need for uterine aspiration or other surgery'}], 'secondaryOutcomes': [{'measure': 'Rate of successful evacuation without any additional intervention', 'timeFrame': '1 week after treatment', 'description': 'uterine evacuation without the need for vacuum aspiration, additional uterotonics or other intervention'}, {'measure': 'Excessive bleeding or a complication for which a woman received treatment', 'timeFrame': '30 days after treatment'}, {'measure': 'Induction expulsion interval after misoprostol administration', 'timeFrame': 'one week follow-up', 'description': 'time interval between misoprostol administration and the expulsion'}, {'measure': 'Acceptability of assigned method to women', 'timeFrame': 'one week follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mifepristone', 'misoprostol', 'obstetrics', 'reproductive health', 'pregnancy', 'abortion', 'missed abortion'], 'conditions': ['Missed Abortion', 'Pregnancy']}, 'descriptionModule': {'briefSummary': 'The purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.', 'detailedDescription': 'The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of missed abortion. This will be a randomized controlled double-blinded trial of 416 women comparing misoprostol alone to mifepristone plus misoprostol for treatment of missed abortion less than 13 weeks+ 0 days LMP. All women in the trial will undergo routine screening (including ultrasound) and pre-medical induction care per standard practice at the hospital. All eligible women agreeing to participate in the study will be randomized to receive one of the following regimens: 1) STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by 800mcg sublingual misoprostol; 2) STUDY GROUP TWO: placebo followed in 24 hours by 800mcg sublingual misoprostol.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ultrasound examination demonstrating:\n\n 1. Evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) OR\n 2. Empty gestational sac with no evidence of incomplete abortion or growth over a 7-day period confirmed by two ultrasounds performed one week apart.\n* If fetus exists, fetal size less than 12 weeks+6 days\n* Closed cervical os\n* Eligible to consent for research according to local regulations\n\nExclusion Criteria:\n\n* Active bleeding at enrollment and/or history of bleeding within the prior week\n* Allergies or other contraindications to the use of mifepristone or misoprostol\n* Suspected ectopic pregnancy\n* History of trophoblastic disease\n* Coagulation disorder and/or currently taking anticoagulants\n* Any serious medical condition'}, 'identificationModule': {'nctId': 'NCT02342002', 'briefTitle': 'Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial', 'orgStudyIdInfo': {'id': '1015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mifepristone-misoprostol regimen', 'description': 'After a woman is determined eligible and signs the informed consent document, she will receive 200 mg mifepristone and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.', 'interventionNames': ['Drug: Mifepristone', 'Drug: Misoprostol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Misoprostol alone regimen', 'description': 'After a woman is determined eligible and signs the informed consent document, she will receive a placebo (of same shape and size of mifepristone) and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.', 'interventionNames': ['Drug: Misoprostol']}], 'interventions': [{'name': 'Mifepristone', 'type': 'DRUG', 'description': 'Mifepristone for treatment of missed abortion', 'armGroupLabels': ['Mifepristone-misoprostol regimen']}, {'name': 'Misoprostol', 'type': 'DRUG', 'description': 'Misoprostol for treatment of missed abortion', 'armGroupLabels': ['Mifepristone-misoprostol regimen', 'Misoprostol alone regimen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Nacional Profesor Alejandro Posadas', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Libreville', 'country': 'Gabon', 'facility': 'CHU Libreville', 'geoPoint': {'lat': 0.39241, 'lon': 9.45356}}, {'city': 'Tlalnepantla', 'country': 'Mexico', 'facility': 'Hospital General Valle Ceylan', 'geoPoint': {'lat': 19.54005, 'lon': -99.19538}}, {'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Agha Khan University Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Hillary Bracken, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}