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

Overview

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.

Full Title of Study: “A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medication Abortion Using a Misoprostol-only Regimen”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2020

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.

Interventions

  • Behavioral: Misoprostol sourced from clinics
    • One cohort of women using misoprostol sourced from clinics
  • Behavioral: Misoprostol sourced from PMVs
    • One cohort of women using misoprostol sourced from PMVs

Arms, Groups and Cohorts

  • Clinic-based
    • Women who get misoprostol from a clinic-based provider
  • PMV-based
    • Women who get misoprostol from a patent medicine vendor

Clinical Trial Outcome Measures

Primary Measures

  • Need for additional treatment to complete abortion
    • Time Frame: 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 Measures

  • Serious complications/ morbidity
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 15 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ipas
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Kristen M Shellenberg, PhD, MPH, 1.310.733.6524, shellenbergk@ipas.org

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