NCT03727308

Study of Clinic-based Versus Self-use of Medical Abortion Pills

A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medical Abortion Using Mifepristone With Misoprostol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,196 (actual)
• Sponsor: Ipas · Academic / Other
• Sex: Female
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Medical abortion with mifepristone and misoprostol within the first 10 weeks of pregnancy is safe and highly effective. Investigators aim to assess whether self-use of early (\<9 weeks) medical abortion using mifepristone with misoprostol results in non-inferior rates of clinical outcomes when compared with clinic-based provision of medical abortion. The investigators will prospectively recruit women who obtain medical abortion medication from pharmacies and clinics. Follow-up will occur by telephone during two phone calls within 30 days following the woman's abortion. A small number of adolescents will be recruited into a qualitative substudy.

Conditions

• Induced Abortion
• First Trimester Abortion
• Misoprostol
• Mifepristone

Interventions

Type	Name	Description
BEHAVIORAL	Medical abortion pills sourced from pharmacies	One cohort using medical abortion pills sourced from pharmacies
BEHAVIORAL	Medical abortion pills sourced from health clinics	One cohort using medical abortion pills sourced from health clinics

Timeline

• Start date: 2018-05-30
• Primary completion: 2021-06-02
• Completion: 2021-06-02
• First posted: 2018-11-01
• Last updated: 2021-09-05

Locations

2 sites across 2 countries: Cambodia, Ghana