Study of Clinic-based vs. Self-use of a Misoprostol-only Regimen for Induced Abortion
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|ClinicalTrials.gov Identifier: NCT04242212|
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : February 24, 2020
|Condition or disease||Intervention/treatment|
|Induced Abortion First Trimester Abortion||Behavioral: Misoprostol sourced from clinics Behavioral: Misoprostol sourced from PMVs|
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|
|Estimated Enrollment :||4000 participants|
|Official Title:||A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medication Abortion Using a Misoprostol-only Regimen|
|Actual Study Start Date :||May 19, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Women who get misoprostol from a clinic-based provider
Behavioral: Misoprostol sourced from clinics
One cohort of women using misoprostol sourced from clinics
Women who get misoprostol from a patent medicine vendor
Behavioral: Misoprostol sourced from PMVs
One cohort of women using misoprostol sourced from PMVs
- Need for additional treatment to complete abortion [ Time Frame: Final assessment at 45 days following misoprostol ]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.
- Serious complications/ morbidity [ Time Frame: Final assessment at 45 days following misoprostol ]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.
- Uptake of postabortion contraception [ Time Frame: Final assessment at 45 days following misoprostol ]Women's reported use of contraception (yes or no and method type) following medication abortion.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242212
|Contact: Kristen M Shellenberg, PhD, MPHemail@example.com|
|Contact: Nathalie Kapp, MD, MPHfirstname.lastname@example.org|
|Awka, Anambra, Nigeria|
|Abeokuta, Ogun, Nigeria|
|Ibadan, Oyo, Nigeria|