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

Ipas

Status

Unknown

Conditions

Induced Abortion

First Trimester Abortion

Treatments

Behavioral: Misoprostol sourced from PMVs

Behavioral: Misoprostol sourced from clinics

Study type

Observational

Funder types

Other

Identifiers

NCT04242212

Ipas_NMAS

Details and patient eligibility

About

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.

Full 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.

Enrollment

4,000 estimated patients

Sex

Female

Ages

15 to 49 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Purchased a misoprostol-only abortion regimen at a PMV or from a clinic
Be at least 15 years of age
Have a known LMP of less than 9 weeks
No contraindications to medical abortion
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 at 1-3, 10-29 and 30-45 days following initial contact.

Exclusion criteria