Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2026-02-11 @ 12:45 AM
Study NCT ID:
NCT04242212
Status:
UNKNOWN
Last Update Posted:
2020-02-24
First Post:
2020-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Clinic-based vs. Self-use of a Misoprostol-only Regimen for Induced Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-21', 'studyFirstSubmitDate': '2020-01-23', 'studyFirstSubmitQcDate': '2020-01-23', 'lastUpdatePostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Uptake of postabortion contraception', 'timeFrame': 'Final assessment at 45 days following misoprostol', 'description': "Women's reported use of contraception (yes or no and method type) following medication abortion."}], 'primaryOutcomes': [{'measure': 'Need for additional treatment to complete abortion', 'timeFrame': 'Final assessment at 45 days following misoprostol', 'description': 'The primary outcome of the study will be the need for additional treatment to complete the abortion (either aspiration or repeated misoprostol \\>3 doses) following a woman taking the medication abortion pills.'}], 'secondaryOutcomes': [{'measure': 'Serious complications/ morbidity', 'timeFrame': 'Final assessment at 45 days following misoprostol', 'description': 'Number of participants who have a complication such as hemorrhage requiring a blood transfusion, hospitalization, serious infection and undiagnosed (at the time of misoprostol) ectopic pregnancy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medication abortion', 'Misoprostol'], 'conditions': ['Induced Abortion', 'First Trimester Abortion']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to determine whether important clinical outcomes differ among women who access a misoprostol-only medication abortion regimen from a patent medicine vendor when compared with those who access it from a clinic.', 'detailedDescription': 'Medication abortion with a misoprostol-only regimen within the first 10 weeks of pregnancy is safe and effective. Investigators aim to assess whether self-use of early (\\<9 weeks) medication abortion using a misoprostol-only regimen results in non-inferior rates of clinical outcomes when compared with clinic-based provision of medication abortion.\n\nThe investigators will prospectively recruit women who obtain misoprostol from patent medicine vendors and clinics. Follow-up will occur by telephone during three phone calls within 45 days of the first dose of misoprostol.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nigerian women, age 15-49, living in the study geography, who are pregnant and seeking a misoprostol-only regimen for medication abortion, either from a patent medicine vendor or a healthcare clinic/facility.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Purchased a misoprostol-only abortion regimen at a PMV or from a clinic\n* Be at least 15 years of age\n* Have a known LMP of less than 9 weeks\n* No contraindications to medical abortion\n* Willing and able to give informed consent\n* Have a mobile phone of which they are the independent user or be willing to be followed-up in person\n* Willing to be contacted with questions about her abortion by telephone at 1-3, 10-29 and 30-45 days following initial contact.\n\nExclusion Criteria:\n\n* Contraindications to misoprostol\n* Age \\<15 or \\>49'}, 'identificationModule': {'nctId': 'NCT04242212', 'briefTitle': 'Study of Clinic-based vs. Self-use of a Misoprostol-only Regimen for Induced Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Ipas'}, 'officialTitle': 'A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medication Abortion Using a Misoprostol-only Regimen', 'orgStudyIdInfo': {'id': 'Ipas_NMAS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clinic-based', 'description': 'Women who get misoprostol from a clinic-based provider', 'interventionNames': ['Behavioral: Misoprostol sourced from clinics']}, {'label': 'PMV-based', 'description': 'Women who get misoprostol from a patent medicine vendor', 'interventionNames': ['Behavioral: Misoprostol sourced from PMVs']}], 'interventions': [{'name': 'Misoprostol sourced from clinics', 'type': 'BEHAVIORAL', 'description': 'One cohort of women using misoprostol sourced from clinics', 'armGroupLabels': ['Clinic-based']}, {'name': 'Misoprostol sourced from PMVs', 'type': 'BEHAVIORAL', 'description': 'One cohort of women using misoprostol sourced from PMVs', 'armGroupLabels': ['PMV-based']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Awka', 'state': 'Anambra', 'status': 'RECRUITING', 'country': 'Nigeria', 'facility': 'Multiple facilities', 'geoPoint': {'lat': 6.21269, 'lon': 7.07199}}, {'city': 'Abeokuta', 'state': 'Ogun State', 'status': 'RECRUITING', 'country': 'Nigeria', 'facility': 'Multiple facilities', 'geoPoint': {'lat': 7.15571, 'lon': 3.34509}}, {'city': 'Ibadan', 'state': 'Oyo State', 'status': 'RECRUITING', 'country': 'Nigeria', 'facility': 'Multiple facilities', 'geoPoint': {'lat': 7.37756, 'lon': 3.90591}}], 'centralContacts': [{'name': 'Kristen M Shellenberg, PhD, MPH', 'role': 'CONTACT', 'email': 'shellenbergk@ipas.org', 'phone': '1.310.733.6524'}, {'name': 'Nathalie Kapp, MD, MPH', 'role': 'CONTACT', 'email': 'kappn@ipas.org', 'phone': '1.919.960.5611'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}