Induced Abortion Clinical Trial
— MOCOfficial title:
A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medical Abortion Using Mifepristone With Misoprostol
NCT number | NCT03727308 |
Other study ID # | 0916 NECHR |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 30, 2018 |
Est. completion date | June 2, 2021 |
Verified date | September 2021 |
Source | Ipas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal of the study is to determine whether important clinical outcomes differ among women who access a combined medical abortion regimen from a pharmacy when compared with those who access it from a facility.
Status | Completed |
Enrollment | 4196 |
Est. completion date | June 2, 2021 |
Est. primary completion date | June 2, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years and older |
Eligibility | Inclusion Criteria: Women are eligible for participation if they have purchased abortion medications (mifepristone-misoprostol) independently at a pharmacy or received them from a clinic for an unwanted pregnancy at less than 9 weeks since her last menstrual period (LMP). She must meet the following criteria: - Be at least 15 years of age (may vary by country) - Have a known LMP of less than 9 weeks - No contraindications to medical abortion (list) - Willing and able to give informed consent - Have a mobile phone of which they are the independent user or be willing to be followed-up in person - Willing to be contacted with questions about her abortion by telephone (optional in-person visit) at 3, 10-14 and 30 days following initial contact. - Resident of country of study. Exclusion criteria: - Contraindications to mifepristone-misoprostol - Age <15 |
Country | Name | City | State |
---|---|---|---|
Cambodia | University of Health Sciences | Phnom Penh | |
Ghana | Regional Institute for Population Studies | Accra |
Lead Sponsor | Collaborator |
---|---|
Ipas | University of Health Science, Phnom Penh, Cambodia |
Cambodia, Ghana,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Uptake of postabortion contraception | Women's reported use of contraception (yes or no and method type) following medical abortion | 30 days | |
Primary | Need for additional treatment to complete abortion | The primary outcome of the study will be the need for additional treatment to complete the abortion (either aspiration or repeated misoprostol) following a woman taking the medical abortion pills. | Final assessment at 30 days following mifepristone administration | |
Secondary | Serious complications/ morbidity | Number of participants who will have a complication such as hemorrhage requiring a blood transfusion, hospitalization, serious infection and undiagnosed (at the time of mifepristone) ectopic pregnancy. | Final assessment at 30 days following mifepristone administration |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
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