Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-04-14 @ 1:56 AM
Study NCT ID:
NCT02363556
Status:
COMPLETED
Last Update Posted:
2017-08-30
First Post:
2015-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004108', 'term': 'Dilatation, Pathologic'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C077755', 'term': 'dilapan'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-28', 'studyFirstSubmitDate': '2015-02-03', 'studyFirstSubmitQcDate': '2015-02-09', 'lastUpdatePostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total procedure time', 'timeFrame': '4-6hrs', 'description': 'Total procedure time is defined as the time required for dilator insertion plus the D\\&E time.'}], 'secondaryOutcomes': [{'measure': 'D&E procedure time', 'timeFrame': '0-60 mins'}, {'measure': 'Initial cervical dilation', 'timeFrame': '0-10 mins', 'description': 'Measured by the largest Hegar dilator accepted without resistance prior to the start of the procedure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cervical Dilation', 'Dilation and Evacuation', 'Misoprostol', 'Misoprostol-Dilapan', 'Abortion'], 'conditions': ['Second Trimester Abortions']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will use a 2 by 2 factorial design to assess methods of cervical preparation prior to Dilation and Evacuations (D\\&Es) at 14 0/7 to 19 6/7 weeks gestational age. In total, 160 woman will be randomized to misoprostol alone or Dilapan with misoprostol and separately randomized to buccal or vaginal administration of 400-mcg misoprostol. A total of 80 women will receive 400-mcg misoprostol only (40 vaginal and 40 buccal). Another 80 women will have Dilapan inserted and then use misoprostol (40 vaginal and 40 buccal). Four to six hours later, the Dilation and Evacuation (D\\&E) procedure will be performed.', 'detailedDescription': 'The primary objective of the study is to compare the efficacy of same-day 400-mcg misoprostol alone to same-day Dilapan with 400-mcg misoprostol for cervical preparation prior to D\\&E at 14 0/7 to 19 6/7 weeks. Patients will first be randomized to misoprostol alone or misoprostol-Dilapan, and then separately randomized to use the misoprostol buccally or vaginally.\n\nThe primary outcome measure is total procedure time. Secondary outcomes include D\\&E procedure time, initial cervical dilation (measured by the largest Hegar dilator accepted without resistance prior to the start of the procedure), patient-oriented outcomes (side effects of buccal and vaginal misoprostol), and patient acceptability and satisfaction.\n\nThe investigators have chosen a randomized controlled trial with a factorial design to be conducted at Washington Hospital Center and Planned Parenthood of Metropolitan Washington. A total up to 180 English speaking women will be enrolled in the study so that 160 will be randomized and receive study interventions. The study will enroll healthy women, over the age of 18, eligible for non-urgent D\\&E at 14 0/7 weeks to 19 6/7 weeks, confirmed by sonogram. The women will be randomized to receive either misoprostol alone or Dilapan with misoprostol. Women will then be randomized to receive 400-mcg of misoprostol either buccally or vaginally. Computer generated randomization will be utilized to assign treatment arms. Approximately 4-6 hours prior to procedure, women will be randomly assigned to one of the following treatment combinations:\n\n1. Misoprostol 400-mcg vaginally\n2. Misoprostol 400-mcg buccally\n3. Dilapan insertion with 400-mcg misoprostol vaginally\n4. Dilapan insertion with 400-mcg misoprostol buccally'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy pregnant women\n* 18 years of age or older\n* Eligible for non-urgent Dilation and Evacuations at 14 0/7 - 19 6/7 weeks gestation confirmed by sonogram.\n\nExclusion Criteria:\n\n* Women who do not speak English.\n* Fetal demise\n* Intolerance, allergy or contraindication to misoprostol or Dilapan.'}, 'identificationModule': {'nctId': 'NCT02363556', 'briefTitle': 'Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'A Factorial-Design Randomized Controlled Trial Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol for Same-Day Cervical Preparation Prior to Dilation & Evacuation', 'orgStudyIdInfo': {'id': '2014-110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Misoprostol Alone', 'description': 'Subjects enrolled into this arm of the study will receive misoprostol 400-mcg only.', 'interventionNames': ['Procedure: Misoprostol administered vaginally', 'Procedure: Misoprostol administered buccally']}, {'type': 'EXPERIMENTAL', 'label': 'Dilapan with Misoprostol', 'description': 'Subjects enrolled into this arm of the study will receive Dilapan with 400-mcg misoprostol.', 'interventionNames': ['Procedure: Misoprostol administered vaginally with Dilapan', 'Procedure: Misoprostol administered buccally with Dilapan']}], 'interventions': [{'name': 'Misoprostol administered vaginally', 'type': 'PROCEDURE', 'armGroupLabels': ['Misoprostol Alone']}, {'name': 'Misoprostol administered buccally', 'type': 'PROCEDURE', 'armGroupLabels': ['Misoprostol Alone']}, {'name': 'Misoprostol administered vaginally with Dilapan', 'type': 'PROCEDURE', 'armGroupLabels': ['Dilapan with Misoprostol']}, {'name': 'Misoprostol administered buccally with Dilapan', 'type': 'PROCEDURE', 'armGroupLabels': ['Dilapan with Misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20910', 'city': 'Silver Spring', 'state': 'Maryland', 'country': 'United States', 'facility': 'Planned Parenthood Metropolitan Washington', 'geoPoint': {'lat': 38.99067, 'lon': -77.02609}}], 'overallOfficials': [{'name': 'Dr. Matthew Reeves, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MedStar Washington Hospital Center & Planned Parenthood of Metropolitan Washington'}, {'name': 'Dr. Jamilah Shakir, MD MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Medstar Health Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Matthew Reeves', 'investigatorAffiliation': 'Medstar Health Research Institute'}}}}