Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT00613366
Status:
COMPLETED
Last Update Posted:
2013-03-15
First Post:
2008-01-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Misoprostol With Intrauterine Device Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D008277', 'term': 'Magnesium Oxide'}, {'id': 'D008274', 'term': 'Magnesium'}], 'ancestors': [{'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'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'}, {'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'edelmana@ohsu.edu', 'phone': '503.494.5949', 'title': 'Dr. Alison Edelman', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Active Drug (Misoprostol)', 'description': '400mcg of buccal misoprostol 90 minutes prior to IUD insertion', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo buccal 90 minutes prior to IUD insertion.', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Drug (Misoprostol)', 'description': '400mcg of buccal misoprostol 90 minutes prior to IUD insertion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo buccal 90 minutes prior to IUD insertion.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'spread': '19', 'groupId': 'OG000'}, {'value': '29', 'spread': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time of IUD insertion', 'description': 'Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT)'}, {'type': 'SECONDARY', 'title': 'Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Drug (Misoprostol)', 'description': '400mcg of buccal misoprostol 90 minutes prior to IUD insertion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo buccal 90 minutes prior to IUD insertion.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '21', 'groupId': 'OG000'}, {'value': '55', 'spread': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At time of IUD insertion', 'description': 'Perceived pain measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Drug (Misoprostol)', 'description': '400mcg of buccal misoprostol 90 minutes prior to IUD insertion'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo buccal 90 minutes prior to IUD insertion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'February 2007-March 2010 in general OB/GYN clinic at an academic hospital', 'preAssignmentDetails': 'Women desiring IUD placement who were nulliparous were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Drug (Misoprostol)', 'description': '400mcg of buccal misoprostol 90 minutes prior to IUD insertion'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo buccal 90 minutes prior to IUD insertion.'}, {'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': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', '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': '25', 'spread': '5', 'groupId': 'BG000'}, {'value': '27', 'spread': '6', 'groupId': 'BG001'}, {'value': '26', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', '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': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-04', 'studyFirstSubmitDate': '2008-01-29', 'resultsFirstSubmitDate': '2012-06-01', 'studyFirstSubmitQcDate': '2008-01-31', 'lastUpdatePostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-04', 'studyFirstPostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS).', 'timeFrame': 'Time of IUD insertion', 'description': 'Provider ease of insertion was measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right).'}], 'secondaryOutcomes': [{'measure': 'Perceived Pain of IUD Insertion by Patient Using a 100mm Visual Analog Scale (VAS).', 'timeFrame': 'At time of IUD insertion', 'description': 'Perceived pain measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain of My Life" (furthest point to the right).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intrauterine device', 'cervical dilation', 'nulliparous women', 'pain management'], 'conditions': ['Contraception']}, 'referencesModule': {'references': [{'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.'}], 'seeAlsoLinks': [{'url': 'http://www.ohsuwomenshealth.com/research/index.html', 'label': "(Women's Health Research Unit website)"}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if using misoprostol (a medication that softens the cervix) before placing an intrauterine device for contraception reduces pain in women who have never delivered a baby.', 'detailedDescription': 'The investigators intend to conduct a randomized double blind study at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette.\n\nSubjects will be approached only after deciding to get an intrauterine. When the participants return for intrauterine device placement, at 90 minutes prior to the procedure half will receive misoprostol and half will receive placebo. The subjects will be asked to rate their level of pain at specific points during the insertion. Providers will be asked to mark whether or not additional dilation was required as well as their perceived ease of intrauterine device placement.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Nulliparous women (defined as those without a history of pregnancy, despite the outcome, beyond 20 weeks gestation)\n* Ages 18-45\n* Seeking long-term reversible contraception with an intrauterine device (either Mirena or Paraguard) through the OHSU Center for Women's Health and Planned Parenthood of the Columbia Willamette\n\nExclusion Criteria:\n\n* Pregnancy occurring less than 6 weeks from time of presentation\n* History of prior intrauterine device placement\n* History of Mullerian tract anomalies\n* History of uterine surgery\n* Allergy or intolerance to misoprostol or other prostaglandin\n* Pelvic inflammatory disease (current or within the past 3 months)\n* Sexually transmitted diseases (current)\n* Puerperal or postabortion sepsis (current or within the past 3 months)\n* Purulent cervicitis (current)\n* Undiagnosed abnormal vaginal bleeding\n* Malignancy of the genital tract\n* Known uterine anomalies or fibroids distorting the cavity in a way incompatible with intrauterine device insertion\n* Allergy to any component of the intrauterine device or Wilson's disease (for copper- containing intrauterine device)"}, 'identificationModule': {'nctId': 'NCT00613366', 'briefTitle': 'Misoprostol With Intrauterine Device Insertion', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Effect of Prophylactic Misoprostol Prior to Intrauterine Device Insertion', 'orgStudyIdInfo': {'id': 'OHSU RES 3489'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Misoprostol', 'description': 'Cervical preparation with misoprostol prior to intrauterine device insertion', 'interventionNames': ['Drug: Misoprostol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Cervical preparation with placebo prior to intrauterine device insertion', 'interventionNames': ['Dietary Supplement: Magnesium Oxide']}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'otherNames': ['prostaglandin'], 'description': 'Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.', 'armGroupLabels': ['Misoprostol']}, {'name': 'Magnesium Oxide', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Magnesium', 'Placebo'], 'description': 'Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97206', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Planned Parenthood of the Columbia Willamette', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Alison Edelman, M.D., M.P.H', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD MPH', 'investigatorFullName': 'Alison Edelman', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}