Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-03-30 @ 4:25 AM
Study NCT ID:
NCT01939457
Status:
COMPLETED
Last Update Posted:
2013-09-11
First Post:
2013-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
400mcg Sublingual Misoprostol as First Line Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000027', 'term': 'Abortion, Incomplete'}], '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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 641}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-06', 'studyFirstSubmitDate': '2013-08-07', 'studyFirstSubmitQcDate': '2013-09-06', 'lastUpdatePostDateStruct': {'date': '2013-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete abortion', 'timeFrame': '1 year', 'description': 'number of complete abortion with misoprostol treatment alone'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Incomplete Abortion']}, 'referencesModule': {'references': [{'pmid': '24893962', 'type': 'DERIVED', 'citation': 'Gaye A, Diop A, Shochet T, Winikoff B. Decentralizing postabortion care in Senegal with misoprostol for incomplete abortion. Int J Gynaecol Obstet. 2014 Sep;126(3):223-6. doi: 10.1016/j.ijgo.2014.03.028. Epub 2014 May 15.'}]}, 'descriptionModule': {'briefSummary': 'Women presenting with incomplete abortion and eligible for treatment with misoprostol were offered 400mcg sublingual misoprostol for treatment. Based on existing literature, the study hypothesises that women can successfully be treated with misoprostol alone as first line treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* uterine size less than 12 weeks lmp\n* open cervical os\n* current or past vaginal bleeding\n* willing to provide contact information for follow-up\n* over 18 or with guardian consent\n\nExclusion Criteria:\n\n* suspicion of ectopic pregnancy\n* intrauterine device in place\n* bad general health (infection, anemia, shoc)'}, 'identificationModule': {'nctId': 'NCT01939457', 'briefTitle': '400mcg Sublingual Misoprostol as First Line Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Introduction of 400mcg Sublingual Misoprostol as First Line Treatment in 11 Health Posts in Three Districts in Senegal', 'orgStudyIdInfo': {'id': '2.2.4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'misoprostol', 'description': '400 mcg misoprostol sublingually', 'interventionNames': ['Drug: Misoprostol']}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'armGroupLabels': ['misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guédiawaye', 'country': 'Senegal', 'facility': 'Guediawaye Health Center', 'geoPoint': {'lat': 14.77446, 'lon': -17.40212}}], 'overallOfficials': [{'name': 'Beverly Winikoff, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}