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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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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