Telemedicine for medication abortion services in Ecuador
Evaluation of Telemedicine Services to Address Urgent Issues Related to Sexual and Reproductive Rights in Ecuador
This study is testing if using telemedicine to provide medication abortion services is safe and acceptable for women in Ecuador who are less than 12 weeks pregnant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 15 Years and up |
| Sex | Female |
| Sponsor | Gynuity Health Projects Academic / other |
| Locations | 3 sites (Ambato and 2 other locations) |
| Trial ID | NCT06270056 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety, feasibility, and acceptability of a telemedicine model for providing legal medication abortion services to women in Ecuador who are less than 12 weeks pregnant. The study aims to enroll 100 participants who seek medication abortion through private sector providers. It will document user interest, perceived benefits and disadvantages of remote care, compliance with telemedicine protocols, and any obstacles encountered during the process. The telemedicine service will mirror the standard in-person medical abortion procedure to ensure quality care.
Who should consider this trial
Good fit: Ideal candidates are women aged 15 and older who are seeking a medication abortion and have access to the internet for remote consultations.
Not a fit: Patients who are medically ineligible for a medication abortion or those without internet access may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance access to safe abortion services for women in Ecuador, promoting their sexual and reproductive rights.
How similar studies have performed: Other studies have shown success with telemedicine approaches for abortion services, indicating potential for this model in Ecuador.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Woman is seeking abortion care and wants to use telemedicine service for her medication abortion procedure. * Woman has access to an internet connection or a device that allows remote consultation. * Woman is 15 years of age or older. * Woman can provide an address to which abortion medications will be mailed. * Woman reports having no contraindications to a medical abortion. * The study provider does not suspect ectopic pregnancy or a nonviable pregnancy. * The gestational age allows sufficient time for the woman to take the misoprostol no later than 84 days of gestation. * A feasible plan is made that the woman agrees to confirm complete abortion and to seek care to manage incomplete abortion complications. * The woman understands the study procedures and is likely to comply with study instructions and has granted informed consent to participate in the study. Exclusion Criteria: * Medically ineligible for procedure. * Provider determines that a medical abortion using the telemedicine approach is not appropriate for that person.
Where this trial is running
Ambato and 2 other locations
- El Comité de Derechos Sexuales y Reproductivos de Ecuador (CODESER) — Ambato, Ecuador (Recruiting)
- Cemoplaf — Quito, Ecuador (Recruiting)
- Federación Nacional de Obstetrices y Obstetras del Ecuador (FENOE) — Quito, Ecuador (Recruiting)
Study contacts
- Principal investigator: Beverly Winikoff, MD, MPH — Gynuity Health Projects
- Study coordinator: Jill Durocher
- Email: jdurocher@gynuity.org
- Phone: 12124481230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.