NCT03931460

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,114

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

4.4 years

First QC Date

April 25, 2019

Last Update Submit

December 1, 2023

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

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

    Adverse Events

    1 year

Interventions

Medical AbortionDRUG

Medical Abortion

Also known as: Medication abortion, abortion with pills

Eligibility Criteria

Age10 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women seeking abortion

You may qualify if:

  • 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.

You may not qualify if:

  • Medically ineligible for procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Telefem

Mexico City, Mexico City, Mexico

Location

Atención Integral en Ginecología,Medieg A.C.

Mexico City, 03100, Mexico

Location

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

Mexico City, 04460, Mexico

Location

Gineclinic

Mexico City, Mexico

Location

MUSOR

Oaxaca City, Mexico

Location

MeSH Terms

Interventions

Abortion, Induced

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Beverly B Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2019

First Posted

April 30, 2019

Study Start

April 1, 2019

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

December 8, 2023

Record last verified: 2023-12

Locations

ME(5)