Study of Clinic-based vs. Self-use of a Misoprostol-only Regimen for Induced Abortion
A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medication Abortion Using a Misoprostol-only Regimen
1 other identifier
observational
4,000
1 country
3
Brief Summary
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.
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 2019
3 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 19, 2019
CompletedFirst Submitted
Initial submission to the registry
January 23, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedFebruary 24, 2020
February 1, 2020
1.1 years
January 23, 2020
February 21, 2020
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 \>3 doses) following a woman taking the medication abortion pills.
Final assessment at 45 days following misoprostol
Secondary Outcomes (1)
Serious complications/ morbidity
Final assessment at 45 days following misoprostol
Other Outcomes (1)
Uptake of postabortion contraception
Final assessment at 45 days following misoprostol
Study Arms (2)
Clinic-based
Women who get misoprostol from a clinic-based provider
PMV-based
Women who get misoprostol from a patent medicine vendor
Interventions
One cohort of women using misoprostol sourced from clinics
One cohort of women using misoprostol sourced from PMVs
Eligibility Criteria
Nigerian women, age 15-49, living in the study geography, who are pregnant and seeking a misoprostol-only regimen for medication abortion, either from a patent medicine vendor or a healthcare clinic/facility.
You may qualify if:
- 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.
You may not qualify if:
- Contraindications to misoprostol
- Age \<15 or \>49
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipaslead
Study Sites (3)
Multiple facilities
Awka, Anambra, Nigeria
Multiple facilities
Abeokuta, Ogun State, Nigeria
Multiple facilities
Ibadan, Oyo State, Nigeria
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2020
First Posted
January 27, 2020
Study Start
May 19, 2019
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
February 24, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share