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Completed

NCT Number: NCT04316325

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.

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Key information

Conditions

Pregnancy

Age range

16 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Reproductive Health Training Center

Chisinau, Moldova

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Abortion

Drug

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

Primary outcomes

  1. Successful termination of pregnancy without adverse events

    Time frame: 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 outcomes

  1. Participant satisfaction with the medical abortion via telemedicine service

    Time frame: through study completion, around 15 months

    Percentage of study participants that report being satisfied or very satisfied with the medical abortion via telemedicine service.

  2. Cost savings experienced by study participants

    Time frame: 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.

  3. Provider satisfaction

    Time frame: through study completion, around 15 months

    Percentage of medical abortion providers that report being satisfied or very satisfied with the telemedicine service provision process.

Sponsors and collaborators

Lead sponsor

Reproductive Health Training Center of the Republic of Moldova

Other

Collaborators

  • Grand Challenges Canada
  • Gynuity Health Projects

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 20, 2020
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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