CClinicalTrials.gg
CompletedNCT03931460Updated Dec 8, 2023

Feasibility of Medical Abortion by Telemedicine in Mexico

An observational study in Pregnancy, sponsored by Gynuity Health Projects. Completed at 5 sites in Mexico. Open to female participants aged 10 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-08.

Sponsored by Gynuity Health Projects · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,114
Ages
10 Years to 50 Years
Sex
Female
01

Study summary

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

Read the detailed description

This is a case-series prospective study to develop, implement, and evaluate a telemedicine medical abortion service in private sector health facilities in Mexico. The service will be designed to incorporate the standard steps in an in-person medical abortion procedure, thus ensuring that the quality of care provided to each woman is equal to that which she would receive if she presented in person to an abortion facility.

Individuals determined as likely to be eligible will have a "TelEvaluation" by videoconference, telephone, messaging, or a combination of these, with a study provider who will give standard pre-abortion counseling and explain study procedures and the process of obtaining informed consent for the study. The informed consent form will be either signed electronically using secure software, or by printing the form, signing, scanning, and returning it to the study site; oral consent recorded by telephone will be also an option. Demographic and medical information will be recorded during the TelEvaluation. If required by the site, the provider will assist in identifying facilities to obtain any tests and have the results sent to the study site.

A person will be eligible for the study if they have no contraindications to medical abortion medications, if an intrauterine pregnancy is determined, and if the provider judge that the participant could receive and take the mifepristone at ≤70 days of gestation. If the individual is eligible and wishes to continue with the abortion, the site will send a package containing one tablet of mifepristone 200 mg, 8 tablets of misoprostol 200 mcg, and 8 tablets of ibuprofen 800 mg once payment for the service is received. Each site will determine the total cost of the service, and the package will be shipped by tracked mail or other reliable means of delivery. Distance to the clinic will be measured using a map application and the address provided by the participant for package receipt. Antibiotics, antiemetics, and contraceptives will be prescribed at the discretion of the site. The package will also include written instructions detailing medication administration, expected symptoms and side effects, the follow up plan, and emergency procedures. The regimen to be used is mifepristone 200 mg followed by misoprostol 800 mcg within 48 h administered buccally or sublingually. The participant will be instructed to take the remaining four misoprostol tablets if no bleeding occurred within 24 hours of taking the misoprostol dose.

A follow-up contact with the study provider will be scheduled for 7 to 14 days after the package is mailed to assess abortion outcome, adverse events, and other relevant information via phone interview or messaging. Study providers will use any combination of methods to determine abortion completeness including ultrasound, serum HCG, urine pregnancy test, and patient's history. If further care is indicated, the provider will refer the participant to a facility. Once it is found that the abortion is complete staff will administer a satisfaction questionnaire.

02

Conditions studied

  • Pregnancy
03

In context

Lead sponsor

Gynuity Health Projects is the lead sponsor of 112 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women seeking abortion

Inclusion criteria

  • Woman is pregnant and desires a medical abortion by remote consult (TeleAborto)
  • 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

Exclusion Criteria:

  • Medically ineligible for procedure.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,114 participants (actual)
Patient registry
No

Interventions

  • DrugMedical Abortion

    Medical Abortion

    Also known as: Medication abortion, abortion with pills

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability

    Adverse Events

    Time frame: 1 year

07

Study locations

5 sites
  • Telefem
    Mexico City, Cdmx, Mexico
  • Atención Integral en Ginecología,Medieg A.C.
    Mexico City, 03100, Mexico
  • Centro de Atención Integral a la Pareja, A.C. (CIPA)
    Mexico City, 04460, Mexico
  • Gineclinic
    Mexico City, Mexico
  • MUSOR
    Oaxaca, Mexico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03931460
Lead sponsor
Gynuity Health Projects
Responsible party
Sponsor
First posted
Apr 30, 2019
Start date
Apr 1, 2019
Primary completion
Aug 31, 2023
Completion
Aug 31, 2023
Last update
Dec 8, 2023

Study contacts

Beverly B Winikoff, MD, MPH
principal investigator · Gynuity Health Projects

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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