Medical Abortion Via Telemedicine for Women and Adolescents in Moldova

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

549 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-20

Study Completion Date

2021-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Women and girls seeking abortion.

Medical abortion

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes