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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Induced Abortion, First Trimester Abortion

Intervention / Treatment
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* Behavioral: Misoprostol sourced from clinics
* Behavioral: Misoprostol sourced from PMVs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinic-based<br>Women who get misoprostol from a clinic-based provider | Behavioral: Misoprostol sourced from clinics<br>* One cohort of women using misoprostol sourced from clinics<br>|
| PMV-based<br>Women who get misoprostol from a patent medicine vendor | Behavioral: Misoprostol sourced from PMVs<br>* One cohort of women using misoprostol sourced from PMVs<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication abortion, Misoprostol