Medical Abortion Via Telemedicine for Women and Adolescents in Moldova

Completed

• Conditions: Pregnancy
• Interventions: Drug: Medical abortion

• Registration Number: NCT04316325
• Lead Sponsor: Reproductive Health Training Center of the Republic of Moldova

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-03-18
• Study First Submitted QC: 2020-03-19
• Study Start: 2020-03-20
• Study First Posted: 2020-03-20
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 549

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women and girls seeking abortion.	Medical abortion	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Reproductive Health Training Center; 🇲🇩 Chisinau, Moldova, Republic of