Study of Clinic-based vs. Self-use of a Misoprostol-only Regimen for Induced Abortion

• Conditions: First Trimester Abortion; Induced Abortion
• Interventions: Behavioral: Misoprostol sourced from PMVs; Behavioral: Misoprostol sourced from clinics

• Registration Number: NCT04242212
• Lead Sponsor: Ipas

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.

Detailed Description

Medication abortion with a misoprostol-only regimen within the first 10 weeks of pregnancy is safe and effective. Investigators aim to assess whether self-use of early (\<9 weeks) medication abortion using a misoprostol-only regimen results in non-inferior rates of clinical outcomes when compared with clinic-based provision of medication abortion.

The investigators will prospectively recruit women who obtain misoprostol from patent medicine vendors and clinics. Follow-up will occur by telephone during three phone calls within 45 days of the first dose of misoprostol.

Study Timeline

• Study Start: 2019-05-19
• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-24
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 4000

Inclusion Criteria

• 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.

Exclusion Criteria

• Contraindications to misoprostol
• Age <15 or >49

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PMV-based	Misoprostol sourced from PMVs	Women who get misoprostol from a patent medicine vendor
Clinic-based	Misoprostol sourced from clinics	Women who get misoprostol from a clinic-based provider

Primary Outcome Measures

Name	Time	Method
Need for additional treatment to complete abortion	Final assessment at 45 days following misoprostol	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.

Secondary Outcome Measures

Name	Time	Method
Serious complications/ morbidity	Final assessment at 45 days following misoprostol	Number of participants who have a complication such as hemorrhage requiring a blood transfusion, hospitalization, serious infection and undiagnosed (at the time of misoprostol) ectopic pregnancy.

Trial Locations

Locations (1)

Multiple facilities; 🇳🇬 Ibadan, Oyo, Nigeria