Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:37 PM
Study NCT ID:
NCT00886834
Status:
COMPLETED
Last Update Posted:
2014-12-22
First Post:
2009-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.turok@hsc.utah.edu', 'phone': '801-581-7647', 'title': 'Dr. David Turok', 'organization': 'University of Utah, Department of Obstetrics and Gynecology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': '2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion.', 'eventGroups': [{'id': 'EG000', 'title': 'Misoprostol', 'description': 'Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.', 'otherNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Pills which are identical to the study drug in appearance, taste, and smell.', 'otherNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Misoprostol'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '25.1', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '27.4', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.64', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately post IUD insertion', 'description': 'VAS (anchors: 0 = extremely easy, 100 mm= impossible)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion.'}, {'type': 'SECONDARY', 'title': 'Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Misoprostol'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'title': 'prior to insertion', 'categories': [{'measurements': [{'value': '17.1', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'immediately after insertion', 'categories': [{'measurements': [{'value': '58.4', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '56.9', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'prior to clinic discharge', 'categories': [{'measurements': [{'value': '35.1', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '27.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'prior to insertion, immediately after insertion, and prior to clinic discharge', 'description': 'VAS; anchors: 0 =none, 100 mm= worst imaginable', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2 of the placebo patients received pre-medication for pain and were excluded and 1 of the placebo patients did not return for IUD insertion.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Misoprostol', 'description': 'Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Pills which are identical to the study drug in appearance, taste, and smell.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Patients were recruited from July 2009 to November 2010. All IUD insertions occurred at the University of Utah Ob/Gyn clinic.', 'preAssignmentDetails': 'Participants had an initial study visit where the consent was signed and they were given misoprostol or placebo to take at home. Participants and providers were blinded to the treatment group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Misoprostol', 'description': 'Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Pills which are identical to the study drug in appearance, taste, and smell.'}, {'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': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '108', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '24.8', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '24.7', 'spread': '4.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-04', 'studyFirstSubmitDate': '2009-04-22', 'resultsFirstSubmitDate': '2011-08-05', 'studyFirstSubmitQcDate': '2009-04-22', 'lastUpdatePostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-12-21', 'studyFirstPostDateStruct': {'date': '2009-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Provider Perceived Ease of Insertion on a 100-point Visual Analogue Scale (VAS)', 'timeFrame': 'Immediately post IUD insertion', 'description': 'VAS (anchors: 0 = extremely easy, 100 mm= impossible)'}], 'secondaryOutcomes': [{'measure': 'Patient Perceived Pain on a 100-point Visual Analogue Scale (VAS)', 'timeFrame': 'prior to insertion, immediately after insertion, and prior to clinic discharge', 'description': 'VAS; anchors: 0 =none, 100 mm= worst imaginable'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IUD insertion', 'Nulliparous women', 'Contraception', 'Family Planning', 'IUD insertion in nulliparous women'], 'conditions': ['Contraception']}, 'referencesModule': {'references': [{'pmid': '22825094', 'type': 'DERIVED', 'citation': 'Swenson C, Turok DK, Ward K, Jacobson JC, Dermish A. Self-administered misoprostol or placebo before intrauterine device insertion in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2012 Aug;120(2 Pt 1):341-7. doi: 10.1097/AOG.0b013e31825d9ec9.'}, {'pmid': '21527040', 'type': 'DERIVED', 'citation': 'Turok DK, Espey E, Edelman AB, Lotke PS, Lathrop EH, Teal SB, Jacobson JC, Simonsen SE, Schulz KF. The methodology for developing a prospective meta-analysis in the family planning community. Trials. 2011 Apr 29;12:104. doi: 10.1186/1745-6215-12-104.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.', 'detailedDescription': "Intrauterine Devices (IUDs) are an excellent method of contraception but are underutilized in the U.S. IUD use is expanding in the U.S. and is now routinely recommended for nulliparous women. The cervix of a nulliparous woman has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause cervical dilation, some family planning providers use this drug to facilitate insertion. While there is a wealth of data on the use of misoprostol prior to many procedures requiring cervical dilation there is minimal objective evidence assessing its effect on provider ease of insertion or patient comfort during IUD insertion in nulliparas. The goal of this project is to evaluate whether misoprostol relative to placebo prior to IUD insertion in nulliparous women eases insertion and decreases pain. The results of this trial will be contributed to a prospective meta-analysis on the subject."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years old or older\n* negative pregnancy test\n* no prior pregnancies beyond 14 6/7 weeks\n* no PID in last 3 months\n* no current cervicitis\n* be willing to follow-up in 1-2 months for an IUD string check.\n\nExclusion Criteria:\n\n* active cervical infection\n* current pregnancy\n* prior pregnancy beyond 14 weeks gestation\n* known uterine anomaly\n* fibroid uterus distorting uterine cavity\n* copper allergy/Wilson's disease (for Paragard)\n* undiagnosed abnormal uterine bleeding\n* cervical or uterine cancer."}, 'identificationModule': {'nctId': 'NCT00886834', 'acronym': 'MPIIN', 'briefTitle': 'Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'A Randomized Control Trial of Misoprostol vs. Placebo Prior to IUD Insertion in Nulliparous Women', 'orgStudyIdInfo': {'id': '24403'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Misoprostol', 'description': 'Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.', 'interventionNames': ['Drug: Misoprostol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Pills which are identical to the study drug in appearance, taste, and smell.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'otherNames': ['Cytotec'], 'description': '400 micrograms inserted vaginally or buccally, per the participants desire prior to the IUD insertion.', 'armGroupLabels': ['Misoprostol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pills which are identical to the study drug in appearance, taste, and smell.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84111', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Planned Parenthood Association of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'David Turok, MD/MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah Department of Obstetrics and Gynecology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'David Turok', 'investigatorAffiliation': 'University of Utah'}}}}