Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-03-05 @ 8:18 AM
Study NCT ID:
NCT02412618
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2015-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation
Sponsor:
Organization:
Raw JSON
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'frances.casey@vcuhealth.org', 'phone': '804-828-7877', 'title': 'Dr. Frances Casey', 'organization': 'VCU Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once\n\nPlacebo: Tasteless, odorless, sugar based pill\n\nMisoprostol: Prostaglandin E1', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mifepristone', 'description': 'Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once\n\nMifepristone: Progesterone antagonist\n\nMisoprostol: Prostaglandin E1', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Initial Cervical Dilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mifepristone', 'description': 'Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once\n\nMifepristone: Progesterone antagonist\n\nMisoprostol: Prostaglandin E1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once\n\nPlacebo: Tasteless, odorless, sugar based pill\n\nMisoprostol: Prostaglandin E1'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '13'}, {'value': '10.9', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '13'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed 4-6 hour following medications at time of D&E procedure', 'description': 'Initial cervical dilation as measured by Hegar Dilator accepted with least resistance', 'unitOfMeasure': 'mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mifepristone', 'description': 'Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once\n\nMifepristone: Progesterone antagonist\n\nMisoprostol: Prostaglandin E1'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once\n\nPlacebo: Tasteless, odorless, sugar based pill\n\nMisoprostol: Prostaglandin E1'}], 'classes': [{'title': 'Nausea', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Severe Cramps', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'intraoperative', 'description': '5-point Likert scale given to patients following procedure once recovered from anesthesia assessing pain, side effects including nausea, vomiting, diarrhea, cramping, and if they would choose the method again or recommend to friends.\n\nLikert scale: Strongly agree (5), Agree (4), Neutral (3), Disagree (2), Strongly Disagree (1)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mifepristone', 'description': 'Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once\n\nMifepristone: Progesterone antagonist\n\nMisoprostol: Prostaglandin E1'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once\n\nPlacebo: Tasteless, odorless, sugar based pill\n\nMisoprostol: Prostaglandin E1'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Expulsion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mifepristone', 'description': 'Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once\n\nMifepristone: Progesterone antagonist\n\nMisoprostol: Prostaglandin E1'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once\n\nMisoprostol: Prostaglandin E1\n\nPlacebo: Tasteless, odorless, sugar based pill'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-08', 'studyFirstSubmitDate': '2015-03-13', 'resultsFirstSubmitDate': '2017-01-13', 'studyFirstSubmitQcDate': '2015-04-08', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-08', 'studyFirstPostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initial Cervical Dilation', 'timeFrame': 'Assessed 4-6 hour following medications at time of D&E procedure', 'description': 'Initial cervical dilation as measured by Hegar Dilator accepted with least resistance'}], 'secondaryOutcomes': [{'measure': 'Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale)', 'timeFrame': 'intraoperative', 'description': '5-point Likert scale given to patients following procedure once recovered from anesthesia assessing pain, side effects including nausea, vomiting, diarrhea, cramping, and if they would choose the method again or recommend to friends.\n\nLikert scale: Strongly agree (5), Agree (4), Neutral (3), Disagree (2), Strongly Disagree (1)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Induced Abortion']}, 'referencesModule': {'references': [{'pmid': '26948184', 'type': 'DERIVED', 'citation': 'Casey FE, Ye PP, Perritt JD, Moreno-Ruiz NL, Reeves MF. A randomized controlled trial evaluating same-day mifepristone and misoprostol compared to misoprostol alone for cervical preparation prior to second-trimester surgical abortion. Contraception. 2016 Aug;94(2):127-33. doi: 10.1016/j.contraception.2016.02.032. Epub 2016 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'A randomized double---blinded comparison of same---day mifepristone and misoprostol with misoprostol only for cervical preparation in second---trimester surgical abortion in 100 women at 14 0/7---19 6/7 weeks gestation.', 'detailedDescription': 'Women desiring abortion at gestational ages between 14 weeks 0 days and 19 weeks 6 days were randomized to 200-mg mifepristone or identical placebo with 400-mcg misoprostol vaginally 4-6 hours prior to D\\&E. Primary outcome was cervical dilation assessed by the largest Hegar dilator accepted without resistance. Secondary outcomes included total procedure time, and patient and provider perceptions. The study was powered to detect a 2-mm difference in cervical dilatation with 48 participants in each arm.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy women\n* eligible for non---urgent D\\&E\n* 14 0/7 weeks to 19 6/7 weeks gestation, confirmed by sonogram\n\nExclusion Criteria:\n\n* emergent need for D\\&E\n* fetal demise\n* intolerance\n* allergy or contraindication to mifepristone or misoprostol'}, 'identificationModule': {'nctId': 'NCT02412618', 'acronym': 'MMSAP', 'briefTitle': 'Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'A Randomized Comparison of Same-Day Oral Mifepristone-Misoprostol to Misoprostol Only for Cervical Preparation in Second Trimester Surgical Abortion', 'orgStudyIdInfo': {'id': '2012-245'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mifepristone', 'description': 'Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once', 'interventionNames': ['Drug: Mifepristone', 'Drug: Misoprostol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once', 'interventionNames': ['Drug: Misoprostol', 'Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Mifepristone', 'type': 'DRUG', 'otherNames': ['Mifeprex'], 'description': 'Progesterone antagonist', 'armGroupLabels': ['Mifepristone']}, {'name': 'Misoprostol', 'type': 'DRUG', 'otherNames': ['Cytotec'], 'description': 'Prostaglandin E1', 'armGroupLabels': ['Mifepristone', 'Placebo']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Tasteless, odorless, sugar based pill', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}