PregnancyNCT04316325
Medical Abortion Via Telemedicine for Women and Adolescents in Moldova
An observational study of Pregnancy, run by Reproductive Health Training Center of the Republic of Moldova at 1 site in Moldova.
Trial summary
This study evaluates the safety, feasibility, and acceptability of a novel medical abortion via telemedicine service in the Republic of Moldova. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Medical abortion
- How many people
- 549 participants
- Where
- 1 siteMoldova
- Study dates
- 20 Mar 2020to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women and girls seeking abortion
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the safety, feasibility, and acceptability of a novel medical abortion via telemedicine service in the Republic of Moldova.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Medical abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical abortionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Women and girls seeking abortion. | Not described Receives: Drug: Medical abortion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, around 15 months
Secondary outcomes (3)
Participant satisfaction with the medical abortion via telemedicine service
Percentage of study participants that report being satisfied or very satisfied with the medical abortion via telemedicine service.
Measured: through study completion, around 15 months
Cost savings experienced by study participants
Percentage cost savings among study participants receiving medical abortion via telemedicine in comparison with the cost of in-person medical abortion.
Measured: through study completion, around 15 months
Provider satisfaction
Percentage of medical abortion providers that report being satisfied or very satisfied with the telemedicine service provision process.
Measured: through study completion, around 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start20 Mar 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 549 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Health Training Center of the Republic of Moldova
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, Gynuity Health Projects
- Responsible party
- Sponsor
- Investigators
- Rodica Comendant, MD,PhD, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316325
- Sponsor's protocol ID
- POC-OPT-1902-31934
- Status last verified
- Sep 2021
- First submitted
- 18 Mar 2020
- Last updated
- 21 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Abortion Via Telemedicine for Women and Adolescents in Moldova
- ClinicalTrials.gov ID
- NCT04316325
- Acronym / sponsor ID
- POC-OPT-1902-31934
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 549 participants (actual)
- Lead sponsor
- Reproductive Health Training Center of the Republic of MoldovaUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, Gynuity Health Projects
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women and girls seeking abortion. | – | Drug: Medical abortion |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women and girls seeking abortion
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical abortionTrained 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 | Drug | Women and girls seeking abortion. |
Primary outcome
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.
3 secondary outcomes
Participant satisfaction with the medical abortion via telemedicine service
Time frame: through study completion, around 15 months
Cost savings experienced by study participants
Time frame: through study completion, around 15 months
Provider satisfaction
Time frame: through study completion, around 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodica Comendant, MD,PhD principal investigator
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Reproductive Health Training Center of the Republic of Moldova at 1 site in Moldova.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful termination of pregnancy without adverse events (time frame: through study completion, around 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.