Medical Abortion Via Telemedicine for Women and Adolescents in Moldova

This study evaluates the safety, feasibility, and acceptability of a novel medical abortion via telemedicine service in the Republic of Moldova.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Drug: Medical abortion

Detailed Description

Women and girls in Moldova, especially those in rural areas, must travel to regional medical centers to obtain an abortion from a certified gynecologist. This creates barriers to accessing safe abortion that disproportionately affect poor women and girls, through wage loss due to missed work and accrued costs due to transportation. This innovation is a novel service delivery model that allows self-management of medical abortion (MA) with remote guidance from a provider. After confirming their pregnancy, women seeking MA will receive counseling from a gynecologist via videoconference and will subsequently obtain the necessary medication via mail or at at participating pharmacy with prescription. Follow-up will occur 1 weeks later via phone/videoconference (with referral to a doctor if necessary) to confirm MA success and assess the patient's and provider's satisfaction with the service. We hope to demonstrate the feasibility, effectiveness and acceptability of telemedicine MA services in Moldova so that it can thus be integrated into the national public healthcare system. As a result, this project will serve as a model that could be adapted and implemented in nearby countries within the Eastern Europe and Central Asia region.

• Study Type: Observational
• Enrollment (Actual): 549

Contacts and Locations

Study Locations

• Moldova, Republic of
  • Chisinau, Moldova, Republic of
    • Reproductive Health Training Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women and girls seeking abortion

Description

Inclusion Criteria:

• 16 years or older
• Has an unwanted pregnancy
• Confirmed the pregnancy using a test or via ultrasound
• Gestational age of 9 weeks or less
• Has personally decided to end the pregnancy
• Has a device (phone, tablet, or computer) with internet connection, a webcam, and a microphone.
• Has immediate access to emergency services
• Reports no contraindication to medical abortion

Exclusion Criteria:

• Under 16 years of age
• Does not have an unwanted pregnancy
• Did not confirm pregnancy
• Gestational age greater than 9 weeks
• Does not have a device (phone, tablet, or computer) with internet connection, a webcam, and a microphone
• Does not have immediate access to emergency services
• Has an intrauterine device
• Is allergic to abortion medications (mifepristone or misoprostol)
• Has severe anemia or acute porphyria
• Has a condition that affects the ability of blood to clot normally
• Has hepatic failure or chronic renal disease
• Has an ectopic pregnancy
• Has heart disease or other cardiovascular problem
• Has a condition that requires hormone treatment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Women and girls seeking abortion.

Drug: Medical abortion; Trained abortion providers will counsel participants about medical abortion via videoconference or telephone, the abortion medications will be sent to the participants via mail or will be accessed at a pharmacy, the provider will follow up one week later with the participants to assess outcomes, and four weeks later the participant will take a pregnancy test to confirm completion of the abortion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful termination of pregnancy without adverse events	Percentage of study participants that successfully terminate their pregnancy via the telemedicine medical abortion model without experiencing any adverse events.	through study completion, around 15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction with the medical abortion via telemedicine service	Percentage of study participants that report being satisfied or very satisfied with the medical abortion via telemedicine service.	through study completion, around 15 months
Cost savings experienced by study participants	Percentage cost savings among study participants receiving medical abortion via telemedicine in comparison with the cost of in-person medical abortion.	through study completion, around 15 months
Provider satisfaction	Percentage of medical abortion providers that report being satisfied or very satisfied with the telemedicine service provision process.	through study completion, around 15 months

Collaborators and Investigators

• Sponsor: Reproductive Health Training Center of the Republic of Moldova
• Collaborators: Grand Challenges Canada; Gynuity Health Projects
• Investigators: Principal Investigator: Rodica Comendant, MD,PhD, Director

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: POC-OPT-1902-31934

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No