Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT04063904
Status:
TERMINATED
Last Update Posted:
2021-07-23
First Post:
2019-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015735', 'term': 'Mifepristone'}, {'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Difficulties with recruitment, COVID 19 pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2019-08-13', 'studyFirstSubmitQcDate': '2019-08-20', 'lastUpdatePostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful medical abortion', 'timeFrame': '0-60 hours after mifepristone', 'description': 'Proportion of women who have a successful abortion with medication only and are discharged from care on the same day as misoprostol induction.'}], 'secondaryOutcomes': [{'measure': 'Induction-to-abortion interval', 'timeFrame': '0-12 hours after misoprostol', 'description': 'Time (median min/hrs) from first misoprostol dose until fetal and placental expulsion'}, {'measure': 'Initiation-to-abortion interval', 'timeFrame': '0-60 hours after mifepristone', 'description': 'Time (median min/hrs) from mifepristone administration until fetal and placental expulsion'}, {'measure': 'Total dose of misoprostol administered', 'timeFrame': '0-12 hours after misoprostol', 'description': 'Mean number of misoprostol doses administered to achieve abortion'}, {'measure': 'Method safety', 'timeFrame': 'Two weeks after mifepristone', 'description': 'Proportion of participants who experience: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications'}, {'measure': 'Tasks performed by clinic staff', 'timeFrame': 'From enrollment through discharge from care (approx. 3 days)', 'description': "Type of task performed (i.e. counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge) per cadre of provider"}, {'measure': 'Total clinic time', 'timeFrame': '0-12 hours from arrival at clinic on day of induction with misoprostol', 'description': 'Time (median hrs) since arrival to clinic on day of misoprostol dosing to discharge from care that same day'}, {'measure': 'Pain with procedure', 'timeFrame': '0-12 hours after first misoprostol dose', 'description': 'Mean pain score (scale 0-10)'}, {'measure': 'Side effects', 'timeFrame': '0-12 hours after first misoprostol dose', 'description': 'Report of side effects and proportion of participants who experienced each one'}, {'measure': 'Satisfaction with procedure', 'timeFrame': 'Prior to discharge from care on day of abortion, up to 12 hours after first misoprostol dose', 'description': 'Proportion of participants who reported the procedure as satisfactory or very satisfactory'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['medical abortion', 'mifepristone'], 'conditions': ['Second Trimester Abortion']}, 'descriptionModule': {'briefSummary': 'This pilot study seeks to evaluate the safety, acceptability and feasibility of a shortened outpatient procedure for medical abortion at 13-18 weeks gestation. It also seeks to document the roles of health workers in providing services related to later abortion care. Participants will take a single dose of 200 mg mifepristone orally, followed 24-48 hours later with 400 mcg misoprostol sublingually prior to arriving at the study clinic. Repeat doses of 400 mcg misoprostol will be administered sublingually every three hours at the clinic until the abortion is achieved. If expulsion does not occur by a certain time prior to the clinic closing that day, D\\&E will be performed to complete the abortion.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have an intrauterine pregnancy of 13-18 weeks gestation according to ultrasound\n2. Meet legal criteria to obtain abortion\n3. Be at least 18 years old\n4. Have access to a phone where she can be reached for the 2-week follow up\n5. Be willing to follow pilot study procedures\n\nExclusion Criteria:\n\n1. Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol\n2. Any contraindications to vaginal delivery\n3. More than one prior cesarean delivery\n4. Staying more than 2 hours away from the clinic'}, 'identificationModule': {'nctId': 'NCT04063904', 'briefTitle': 'Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Pilot Study of an Ambulatory Medical Abortion Service at 13-18 Weeks of Gestation in Colombia', 'orgStudyIdInfo': {'id': '1044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mifepristone and misoprostol', 'description': 'Mifepristone 200 mg orally, followed 24-48 hours later by misoprostol 400mcg sublingually every three hours until the abortion occurs. The experimental part of the regimen is that the first dose of misoprostol will be taken 1-2 hours before arriving at the clinic for continued dosing, monitoring and abortion completion.', 'interventionNames': ['Drug: Mifepristone', 'Drug: Misoprostol']}], 'interventions': [{'name': 'Mifepristone', 'type': 'DRUG', 'description': 'One 200 mg pill (oral)', 'armGroupLabels': ['Mifepristone and misoprostol']}, {'name': 'Misoprostol', 'type': 'DRUG', 'description': 'Two 400 mcg pills (sublingual)', 'armGroupLabels': ['Mifepristone and misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Fundacion Orientame', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}], 'overallOfficials': [{'name': 'Ilana G Dzuba, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Maria Mercedes Vivas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundacion Orientame'}, {'name': 'Juliette Ortiz', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fundacion Orientame'}, {'name': 'Beverly Winikoff, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}