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

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.

Study Overview

• Status: Unknown
• Conditions: Induced Abortion; First Trimester Abortion
• Intervention / Treatment: Behavioral: Misoprostol sourced from clinics; Behavioral: Misoprostol sourced from PMVs

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 Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

• Study Contact: Name: Kristen M Shellenberg, PhD, MPH; Phone Number: 1.310.733.6524; Email: shellenbergk@ipas.org
• Study Contact Backup: Name: Nathalie Kapp, MD, MPH; Phone Number: 1.919.960.5611; Email: kappn@ipas.org

Study Locations

• Nigeria
  • Anambra
    • Awka, Anambra, Nigeria
      • Recruiting
      • Multiple facilities
  • Ogun
    • Abeokuta, Ogun, Nigeria
      • Recruiting
      • Multiple facilities
  • Oyo
    • Ibadan, Oyo, Nigeria
      • Recruiting
      • Multiple facilities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clinic-based; Women who get misoprostol from a clinic-based provider	Behavioral: Misoprostol sourced from clinics; One cohort of women using misoprostol sourced from clinics
PMV-based; Women who get misoprostol from a patent medicine vendor	Behavioral: Misoprostol sourced from PMVs; One cohort of women using misoprostol sourced from PMVs

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 >3 doses) following a woman taking the medication abortion pills.	Final assessment at 45 days following misoprostol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious complications/ morbidity	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.	Final assessment at 45 days following misoprostol

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 medication abortion.	Final assessment at 45 days following misoprostol

Collaborators and Investigators

• Sponsor: Ipas

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 19, 2019
• Primary Completion (ANTICIPATED): June 30, 2020
• Study Completion (ANTICIPATED): June 30, 2020

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (ACTUAL): January 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Misoprostol; Medication abortion
• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: Ipas_NMAS

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