Study of Clinic-based Versus Self-use of Medical Abortion Pills (MOC)

Ipas

Status: Completed

Conditions: Induced Abortion; First Trimester Abortion; Misoprostol; Mifepristone

Treatments: Behavioral: Medical abortion pills sourced from health clinics; Behavioral: Medical abortion pills sourced from pharmacies

Study type: Observational

Funder types: Other

Identifiers

NCT03727308

0916 NECHR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,196 patients

Sex: Female

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

4,196 participants in 2 patient groups

Women recruited from pharmacies

Description:

Investigators will enroll women seeking medical abortion pills without prescription from pharmacies. - Medical abortion pills sourced from pharmacies

Treatment:

Behavioral: Medical abortion pills sourced from pharmacies

Women recruited from health clinics

Description:

Investigators will enroll women seeking medical abortion pills from clinics. - Medical abortion pills sourced from health clinics

Treatment:

Behavioral: Medical abortion pills sourced from health clinics