Telemedicine Medical Abortion Service Using the No-test Protocol in Azerbaijan.

Study Overview
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Brief Summary
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The goal of this study is to pilot and evaluate a telemedicine medical abortion service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers.

Detailed Description
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The goal of this study is to pilot and evaluate a telemedicine medical abortion (TMA) service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers. Providers will provide counseling by phone or video about pregnancy options and give detailed information about the medical abortion process, expected side effects, and where to seek additional care. The provider will then evaluate the woman's eligibility for TMA service by following the no-test protocol and discuss at-home follow-up using a symptom checklist and a high-sensitivity urine pregnancy test. If pre-treatment tests are needed, women will be referred to a nearby diagnostic center and test results will be forwarded to the study provider. Participants will receive medications by mail or courier service or pick them up at the pharmacy or study clinics, take medications as instructed, and complete at-home follow-ups as discussed with the provider.

Official Title
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Safety and Acceptability of Telemedicine Medical Abortion Service Using the No-test Protocol in Azerbaijan.

Conditions
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Pregnancy Related

Intervention / Treatment
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* Drug: Medical Abortion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is pregnant as determined by a pregnancy test or ultrasound (if obtained prior to contacting the study site) Has no contraindications to medical abortion Has access to a phone Is able to take mifepristone on or before 63 days of gestation Exclusion Criteria: Medically ineligible for medical abortion Gestational age above 63 days based on LMP
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

| Intervention/Treatment |
| --- |
|Drug: Medical Abortion|Medical Abortion|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence rate of adverse events resulting from the remote provision of medical abortion | Adverse events such as regimen non-compliance or medically unnecessary interventions associated with remote provision of medical abortion. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with remote provision of medical abortion | Satisfaction with remote provision of medical abortion measures by 5-point Likert scale. We will be using a 1-5 score system. 1 being very satisfied and 5 being very unsatisfied. A higher score means a worse outcome. | 6-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Pregnancy