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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.

Feasibility of Medical Abortion by Telemedicine in Mexico

Clinicaltrials.gov identifier NCT03931460

Recruitment Status Recruiting

First Posted April 30, 2019

Last update posted June 16, 2020

Study Description

Brief summary:

This study is designed to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion in Mexico.

  • Condition or Disease:Pregnancy
  • Intervention/Treatment: Drug: Medical Abortion
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 100 participants
  • Observational Model: Case-Only
  • Time Perspective: Prospective
  • Official Title: Feasibility of Medical Abortion by Telemedicine in Mexico
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: March 2021
  • Estimated Study Completion Date: March 2021
Outcome Measures
  • Primary Outcome Measures: 1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ]
    Adverse Events
Eligibility Criteria
  • Ages Eligible for Study: 10 to 50 Years (Child, Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • Study Population: Women seeking abortion
Criteria

Inclusion Criteria:

- Woman is pregnant and desires a medical abortion by remote consult (TeleILE)

- Woman has access to internet or equipment for a remote consult

- Woman can provide address to which abortifacient medications will be mailed

- Woman reports no contraindications to medical abortion

- The study site does not suspect an ectopic pregnancy or nonviable pregnancy

- The gestational age allows sufficient time for the woman to take the mifepristone on
or before 70 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 and is likely to comply with study instructions and has granted
informed consent to participate in the study.

Exclusion Criteria:

- Medically ineligible for procedure.

Contacts and Locations
Contacts

Contact: Melanie Pena, MPH, MA (212) 448-1230 mpena@gynuity.org

Contact: Manuel Bousiéguez, MBA (212) 448-1230 mbousieguez@gynuity.org

Locations

Mexico, Chiapas
Clinica AMASS
San Cristobal de las Casas

Mexico, Yucatan
Servicios Humanitarios en Salud Sexual y Reproductiva (SHSSR)
Merida

Mexico
Atención Integral en Ginecología,Medieg A.C.
Mexico City

Mexico
Centro de Atención Integral a la Pareja, A.C. (CIPA)
Mexico City

Mexico
Gineclinic
Mexico City

Sponsors and Collaborators

Gynuity Health Projects

More Information
  • Responsible Party: Gynuity Health Projects
  • ClinicalTrials.gov Identifier: NCT03931460 History of Changes
  • Other Study ID Numbers: 1045
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: June 16, 2020
  • Last Verified: June 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No