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

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.

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.

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