Abortion EarlyPhase 4NCT04458558
Improving Access to Abortion in the Republic of Georgia
A Phase 4 study testing Mifepristone in people with Abortion Early and Pregnancy Related, run by Center for Information and Counseling on Reproductive Health - Tanadgoma at 3 sites in Georgia.
Trial summary
In the Republic of Georgia, the medical abortion regimen involves three in-person visits. This study aims to pilot and evaluate a simplified medical abortion service delivery model that will reduce the number of in-person visits to only one visit for diagnosis and counseling. 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
- Abortion Early, Pregnancy Related
- What is being tested?
- Mifepristone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesGeorgia
- Study dates
- 30 Jun 2020to 1 Apr 2021
- Phase
- Phase 4
- 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
Who may be able to join
- Women seeking medical abortion through 58 days gestation
- Eligible for medical abortion according to study provider's assessment
- Able to receive physical mail
- Have access to a phone
- Be willing and able to consent to participate in the study
- Be willing to follow study procedures
Who cannot join
- Not seeking medical abortion
- Contraindications to medical abortion
Trial locations and contacts
3 sites in 1 country.
Georgia3 sites, 3 recruiting
- Recruiting
Batumi Medical Center
Batumi
Temur Gabaidze, MD, +995 577 442 328
- Recruiting
David Gagua Clinic
Tbilisi
George Tsertsvadze, MD, +995 599 553 047
- Recruiting
Clinic Elite
Zestaponi
Kote Bochorishvili, MD, +995 599 516 227
About this study
In the Republic of Georgia, the medical abortion regimen involves three in-person visits. This study aims to pilot and evaluate a simplified medical abortion service delivery model that will reduce the number of in-person visits to only one visit for diagnosis and counseling. Medication will be mailed along with two multi-level pregnancy tests to study participants, who will assess their abortion outcome at home.
Read the detailed description
This prospective cohort study of patients obtaining medical abortion medications by mail. The study investigators aim to recruit approximately 120 patients for this study across three study sites that have extensive experience providing early medical abortion. Five days after undergoing in-person consultation and necessary exams to assess eligibility for medical abortion, study team will mail study participants medical abortion pills and two multi-level urine pregnancy tests. Medical abortion follow-up will occur at the participant's home approximately two weeks after the initial visit, and the multi-level pregnancy test will be used to assess abortion outcome. At follow-up, study participants will be asked questions about the results of the multi-level pregnancy test, and their experience and feedback about the acceptability of the process. At the conclusion of the study, investigators will interview providers to better undertand their experience with the simplified medical abortion service delivery model.
- Conditions
- Abortion Early, Pregnancy Related
- Being tested
- Mifepristone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Participants will receive mifepristone at a preferred address by mail rather than standard care at clinic visit.
| Study group | Role | What they receive |
|---|---|---|
| Medical abortion patients | Experimental | Oral mifepristone 200 mg followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone). Receives: Drug: Mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who report satisfactory experience
Number of participants who report being "satisfied" or "very satisfied" with the simplified medical abortion service delivery model
Measured: Day 14 following initial medical abortion visit
Number of providers who report satisfactory experience
Number of providers who report being "satisfied" or "very satisfied" with the simplified medical abortion service delivery model
Measured: End of the study, month 15
Secondary outcomes (5)
Number of participants with adverse event
Number of participants who had a medical problem that required them to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving medical abortion pills
Measured: Up to 6 weeks after initial medical abortion visit
Number of participants with a complete abortion with medication alone and who do not require additional interventions to complete the procedure
Number of participants who report that their abortion is complete as assessed by the multi-level pregnancy test and medical history.
Measured: Up to 6 weeks after initial medical abortion visit
Number of particpants with adverse event associated with mailing of medical abortion medications
Number of participants who had a problem (such as delayed and lost packages) receiving medical abortion medications by mail
Measured: Up to 6 weeks after initial medical abortion visit
Cost associated with the simplified medical abortion service delivery model
Cost savings associated with participant travel to the clinic and cost of the standard care at the clinic.
Measured: Up to 6 weeks after initial medical abortion visit
Number of participants who refuse to receive medical abortion pills by mail
Number of participants who refuse to receive medical abortion pills by mail during the study period
Measured: End of the study, month 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start30 Jun 2020
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion EarlyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Cohort
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Information and Counseling on Reproductive Health - Tanadgoma
- Sponsor type
- University, hospital or other
- Collaborators
- Gynuity Health Projects, Healthy Life, Grand Challenges Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458558
- Sponsor's protocol ID
- 2.1
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to Abortion in the Republic of Georgia
- ClinicalTrials.gov ID
- NCT04458558
- Acronym / sponsor ID
- 2.1
- Conditions
- Abortion Early, Pregnancy Related
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Center for Information and Counseling on Reproductive Health - TanadgomaUniversity, hospital or other
- Collaborators
- Gynuity Health Projects, Healthy Life, Grand Challenges Canada
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 7 Jul 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.
In the Republic of Georgia, the medical abortion regimen involves three in-person visits. This study aims to pilot and evaluate a simplified medical abortion service delivery model that will reduce the number of in-person visits to only one visit for diagnosis and counseling. Medication will be mailed along with two multi-level pregnancy tests to study participants, who will assess their abortion outcome at home.
Detailed description
This prospective cohort study of patients obtaining medical abortion medications by mail. The study investigators aim to recruit approximately 120 patients for this study across three study sites that have extensive experience providing early medical abortion. Five days after undergoing in-person consultation and necessary exams to assess eligibility for medical abortion, study team will mail study participants medical abortion pills and two multi-level urine pregnancy tests. Medical abortion follow-up will occur at the participant's home approximately two weeks after the initial visit, and the multi-level pregnancy test will be used to assess abortion outcome. At follow-up, study participants will be asked questions about the results of the multi-level pregnancy test, and their experience and feedback about the acceptability of the process. At the conclusion of the study, investigators will interview providers to better undertand their experience with the simplified medical abortion service delivery model.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Cohort
| Arm | Type | Receives |
|---|---|---|
| Medical abortion patients | Experimental | Drug: MifepristoneOral mifepristone 200 mg followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone). |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Women seeking medical abortion through 58 days gestation
- Eligible for medical abortion according to study provider's assessment
- Able to receive physical mail
- Have access to a phone
- Be willing and able to consent to participate in the study
Key exclusion criteria (2 listed)
- Not seeking medical abortion
- Contraindications to medical abortion
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 |
|---|---|---|
| MifepristoneParticipants will receive mifepristone at a preferred address by mail rather than standard care at clinic visit. | Drug | Medical abortion patients |
Primary outcome
Number of participants who report satisfactory experience
Time frame: Day 14 following initial medical abortion visit
Number of participants who report being "satisfied" or "very satisfied" with the simplified medical abortion service delivery model
Number of providers who report satisfactory experience
Time frame: End of the study, month 15
Number of providers who report being "satisfied" or "very satisfied" with the simplified medical abortion service delivery model
5 secondary outcomes
Number of participants with adverse event
Time frame: Up to 6 weeks after initial medical abortion visit
Number of participants with a complete abortion with medication alone and who do not require additional interventions to complete the procedure
Time frame: Up to 6 weeks after initial medical abortion visit
Number of particpants with adverse event associated with mailing of medical abortion medications
Time frame: Up to 6 weeks after initial medical abortion visit
Cost associated with the simplified medical abortion service delivery model
Time frame: Up to 6 weeks after initial medical abortion visit
Number of participants who refuse to receive medical abortion pills by mail
Time frame: End of the study, month 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mifepristone in people with Abortion Early and Pregnancy Related, run by Center for Information and Counseling on Reproductive Health - Tanadgoma at 3 sites in Georgia.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Georgia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nino Tsereteli, MA (+995 599 158 030, tsereteli_nino@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who report satisfactory experience (time frame: Day 14 following initial medical abortion visit). The study lists 2 primary outcomes in all. 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 7 Jul 2020.