NCT06270056

Brief Summary

This research seeks to demonstrate that a telemedicine model for the provision of legal abortion services in Ecuador is safe, feasible and acceptable to users requesting a medication abortion and who are less than 12 weeks pregnant.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

3 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

February 6, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

July 24, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

February 6, 2024

Last Update Submit

October 11, 2024

Conditions

Pregnancy

Keywords

abortion

Outcome Measures

Primary Outcomes (1)

  • Adverse events (safety)

    Incidence of adverse events among those who self-administered medication abortion regimen

    6 weeks

Secondary Outcomes (2)

  • Feasibility of telemedicine service

    6 weeks

  • Acceptability of telemedicine service

    6 weeks

Study Arms (1)

early medication abortion via telemedicine

Medication abortion up to 84 days gestation using misoprostol alone regimen consisting of three doses 800mcg (4 tablets of 200mcg misoprostol each) taken every 3 hours. An extra dose (800mcg) may also be taken if there was no bleeding after administering the earlier doses.

Drug: Misoprostol

Interventions

MisoprostolDRUG

Self-administered misoprostol by clients obtaining medication abortion via telemedicine

Also known as: Cytotec
early medication abortion via telemedicine

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women seeking abortion

You may qualify if:

  • 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.

You may not qualify if:

  • Medically ineligible for procedure.
  • Provider determines that a medical abortion using the telemedicine approach is not appropriate for that person.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Related Publications (3)

  • Pena M, Figueroa Flores K, Munoz Ponce M, Facio Serafin D, Camarillo Zavala AM, Ruiz Cruz C, Ortiz Salgado IG, Ochoa Rosado Y, Socarras T, Pacheco Lopez A, Bousieguez M. Telemedicine for medical abortion service provision in Mexico: A safety, feasibility, and acceptability study. Contraception. 2022 Oct;114:67-73. doi: 10.1016/j.contraception.2022.06.009. Epub 2022 Jun 24.

    PMID: 35753406BACKGROUND

  • Raymond EG, Weaver MA, Shochet T. Effectiveness and safety of misoprostol-only for first-trimester medication abortion: An updated systematic review and meta-analysis. Contraception. 2023 Nov;127:110132. doi: 10.1016/j.contraception.2023.110132. Epub 2023 Jul 29.

    PMID: 37517447BACKGROUND

  • Sheldon WR, Durocher J, Dzuba IG, Sayette H, Martin R, Velasco MC, Winikoff B. Early abortion with buccal versus sublingual misoprostol alone: a multicenter, randomized trial. Contraception. 2019 May;99(5):272-277. doi: 10.1016/j.contraception.2019.02.002. Epub 2019 Mar 1.

    PMID: 30831103BACKGROUND

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Durocher

CONTACT

12124481230jdurocher@gynuity.org

Manuel Bousieguez

CONTACT

12124481230mbousieguez@gynuity.org

Study Design

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

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 21, 2024

Study Start

July 24, 2024

Primary Completion

July 1, 2025

Study Completion

September 1, 2025

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations

EC(3)