NCT04242212

Study of Clinic-based vs. Self-use of a Misoprostol-only Regimen for Induced Abortion

A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medication Abortion Using a Misoprostol-only Regimen

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Ipas · Academic / Other
• Sex: Female
• Age: 15 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Induced Abortion
• First Trimester Abortion

Interventions

Type	Name	Description
BEHAVIORAL	Misoprostol sourced from clinics	One cohort of women using misoprostol sourced from clinics
BEHAVIORAL	Misoprostol sourced from PMVs	One cohort of women using misoprostol sourced from PMVs

Timeline

• Start date: 2019-05-19
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2020-01-27
• Last updated: 2020-02-24

Locations

3 sites across 1 country: Nigeria