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.
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. The 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.
Study Type
OBSERVATIONAL
Enrollment
4,000
One cohort of women using misoprostol sourced from clinics
One cohort of women using misoprostol sourced from PMVs
Multiple facilities
Awka, Anambra, Nigeria
RECRUITINGMultiple facilities
Abeokuta, Ogun State, Nigeria
RECRUITINGMultiple facilities
Ibadan, Oyo State, Nigeria
RECRUITINGNeed 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 \>3 doses) following a woman taking the medication abortion pills.
Time frame: Final assessment at 45 days following misoprostol
Serious complications/ morbidity
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.
Time frame: Final assessment at 45 days following misoprostol
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