Study of Clinic-based Versus Self-use of Medical Abortion Pills

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-30

Study Completion Date

2021-06-02

Brief Summary

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The goal of the study is to determine whether important clinical outcomes differ among women who access a combined medical abortion regimen from a pharmacy when compared with those who access it from a facility.

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Detailed Description

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

The investigators will prospectively recruit women who obtain medical abortion medication from pharmacies and clinics. Follow-up will occur by telephone during two phone calls within 30 days following the woman's abortion. A small number of adolescents will be recruited into a qualitative substudy.

Conditions

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Induced Abortion First Trimester Abortion Misoprostol Mifepristone

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women recruited from pharmacies

Investigators will enroll women seeking medical abortion pills without prescription from pharmacies.

\- Medical abortion pills sourced from pharmacies

Medical abortion pills sourced from pharmacies

Intervention Type BEHAVIORAL

One cohort using medical abortion pills sourced from pharmacies

Women recruited from health clinics

Investigators will enroll women seeking medical abortion pills from clinics.

\- Medical abortion pills sourced from health clinics

Medical abortion pills sourced from health clinics

Intervention Type BEHAVIORAL

One cohort using medical abortion pills sourced from health clinics

Interventions

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Medical abortion pills sourced from pharmacies

One cohort using medical abortion pills sourced from pharmacies

Intervention Type BEHAVIORAL

Medical abortion pills sourced from health clinics

One cohort using medical abortion pills sourced from health clinics

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Women are eligible for participation if they have purchased abortion medications (mifepristone-misoprostol) independently at a pharmacy or received them from a clinic for an unwanted pregnancy at less than 9 weeks since her last menstrual period (LMP). She must meet the following criteria:

* Be at least 15 years of age (may vary by country)
* Have a known LMP of less than 9 weeks
* No contraindications to medical abortion (list)
* 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 (optional in-person visit) at 3, 10-14 and 30 days following initial contact.
* Resident of country of study.