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

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.

Study Overview

• Status: Completed
• Conditions: Misoprostol; Induced Abortion; First Trimester Abortion; Mifepristone
• Intervention / Treatment: Behavioral: Medical abortion pills sourced from pharmacies; Behavioral: Medical abortion pills sourced from health clinics

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 Type: Observational
• Enrollment (Actual): 4196

Contacts and Locations

Study Locations

• Cambodia
  • Phnom Penh, Cambodia
    • University of Health Sciences
• Ghana
  • Accra, Ghana
    • Regional Institute for Population Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women who are pregnant and seeking abortion in study sites.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women recruited from pharmacies; Investigators will enroll women seeking medical abortion pills without prescription from pharmacies. - Medical abortion pills sourced from pharmacies	Behavioral: Medical abortion pills sourced from pharmacies; One cohort using medical abortion pills sourced from pharmacies
Women recruited from health clinics; Investigators will enroll women seeking medical abortion pills from clinics. - Medical abortion pills sourced from health clinics	Behavioral: Medical abortion pills sourced from health clinics; One cohort using medical abortion pills sourced from health clinics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for additional treatment to complete abortion	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.	Final assessment at 30 days following mifepristone administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious complications/ morbidity	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.	Final assessment at 30 days following mifepristone administration

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake of postabortion contraception	Women's reported use of contraception (yes or no and method type) following medical abortion	30 days

Collaborators and Investigators

• Sponsor: Ipas
• Collaborators: University of Health Science, Phnom Penh, Cambodia
• Investigators: Principal Investigator: Nathalie Kapp, MD, MPH, Ipas

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2018
• Primary Completion (Actual): June 2, 2021
• Study Completion (Actual): June 2, 2021

Study Registration Dates

• First Submitted: October 28, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: medical abortion; self-use
• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous
• Other Study ID Numbers: 0916 NECHR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No