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

Completed

• Conditions: Induced Abortion; Misoprostol; First Trimester Abortion; Mifepristone
• Interventions: Behavioral: Medical abortion pills sourced from pharmacies; Behavioral: Medical abortion pills sourced from health clinics

• Registration Number: NCT03727308
• Lead Sponsor: Ipas

Brief 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.

Study Timeline

• Study Start: 2018-05-30
• Study First Submitted: 2018-10-28
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-01
• Primary Completion: 2021-06-02
• Study Completion: 2021-06-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4196

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women recruited from pharmacies	Medical abortion pills sourced from pharmacies	Investigators will enroll women seeking medical abortion pills without prescription from pharmacies. - Medical abortion pills sourced from pharmacies
Women recruited from health clinics	Medical abortion pills sourced from health clinics	Investigators will enroll women seeking medical abortion pills from clinics. - Medical abortion pills sourced from health clinics

Primary Outcome Measures

Name	Time	Method
Need for additional treatment to complete abortion	Final assessment at 30 days following mifepristone administration	The primary outcome of the study will be the need for additional treatment to complete the abortion (either aspiration or repeated misoprostol) following a woman taking the medical abortion pills.

Secondary Outcome Measures

Name	Time	Method
Serious complications/ morbidity	Final assessment at 30 days following mifepristone administration	Number of participants who will have a complication such as hemorrhage requiring a blood transfusion, hospitalization, serious infection and undiagnosed (at the time of mifepristone) ectopic pregnancy.

Trial Locations

Locations (2)

Regional Institute for Population Studies; 🇬🇭 Accra, Ghana

University of Health Sciences; 🇰🇭 Phnom Penh, Cambodia