Clinical trial NCT04316325: Medical Abortion Via Telemedicine for Women and Adolescents in Moldova
Official title: Medical Abortion Via Telemedicine for Women and Adolescents in Moldova
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: Reproductive Health Training Center of the Republic of Moldova
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: Gynuity Health Projects
First posted: 2020-03-20
Enrollment: 549
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women and girls seeking abortion

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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful termination of pregnancy without adverse events
timeFrame: through study completion, around 15 months
Secondary outcomes:
measure: Participant satisfaction with the medical abortion via telemedicine service
timeFrame: through study completion, around 15 months
measure: Cost savings experienced by study participants
timeFrame: through study completion, around 15 months
measure: Provider satisfaction
timeFrame: through study completion, around 15 months
Other outcomes:
Locations:
city: Chisinau
country: Moldova, Republic of
facility: Reproductive Health Training Center
Study officials:
affiliation: Director
name: Rodica Comendant, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: