Medical Abortion Via Telemedicine for Women and Adolescents in Moldova

NCT04316325 | Completed

• 1 other identifier: POC-OPT-1902-31934
• Study Type: observational
• Target: 549
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Participant satisfaction with the medical abortion via telemedicine service

  through study completion, around 15 months

• Cost savings experienced by study participants

  through study completion, around 15 months

• Provider satisfaction

  through study completion, around 15 months

Study Arms (1)

Women and girls seeking abortion.

Drug: Medical abortion

Interventions

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

Women and girls seeking abortion.

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women and girls seeking abortion

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reproductive Health Training Center of the Republic of Moldova: lead
• Grand Challenges Canada: collaborator
• Gynuity Health Projects: collaborator

Study Sites (1)

Reproductive Health Training Center

Chisinau, Moldova

Location

Study Officials

• Rodica Comendant, MD,PhD

  Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 20, 2020
• Study Start: March 20, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

MO (1)