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
1 other identifier
observational
4,196
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 30, 2018
CompletedFirst Submitted
Initial submission to the registry
October 28, 2018
CompletedFirst Posted
Study publicly available on registry
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2021
CompletedSeptember 5, 2021
September 1, 2021
3 years
October 28, 2018
September 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Serious complications/ morbidity
Final assessment at 30 days following mifepristone administration
Other Outcomes (1)
Uptake of postabortion contraception
30 days
Study Arms (2)
Women recruited 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
Investigators will enroll women seeking medical abortion pills from clinics. \- Medical abortion pills sourced from health clinics
Interventions
One cohort using medical abortion pills sourced from pharmacies
One cohort using medical abortion pills sourced from health clinics
Eligibility Criteria
Women who are pregnant and seeking abortion in study sites.
You may qualify if:
- 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.
You may not qualify if:
- Contraindications to mifepristone-misoprostol
- Age \<15
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipaslead
- University of Health Science, Phnom Penh, Cambodiacollaborator
Study Sites (2)
University of Health Sciences
Phnom Penh, Cambodia
Regional Institute for Population Studies
Accra, Ghana
Related Publications (1)
Kapp N, Bawah AA, Agula C, Menzel JL, Antobam SK, Asuming PO, Eckersberger E, Pearson EE. Medical abortion in Ghana: A non-randomized, non-inferiority study of access through pharmacies compared with clinics. Contraception. 2024 Dec;140:110538. doi: 10.1016/j.contraception.2024.110538. Epub 2024 Jul 11.
PMID: 39002625DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Nathalie Kapp, MD, MPH
Ipas
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2018
First Posted
November 1, 2018
Study Start
May 30, 2018
Primary Completion
June 2, 2021
Study Completion
June 2, 2021
Last Updated
September 5, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share