A Prospective, Comparative Study of Clinical Outcomes Following Clinic-based Versus Self-use of Medication Abortion Using a Misoprostol-only Regimen
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Induced Abortion
- Sponsor
- Ipas
- Enrollment
- 4000
- Locations
- 1
- Primary Endpoint
- Need for additional treatment to complete abortion
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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 Outcomes
- Serious complications/ morbidity(Final assessment at 45 days following misoprostol)