Abortion, TherapeuticPhase 4NCT02981030
Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine
A Phase 4 study testing Mifepristone and Misoprostol in people with Abortion, Therapeutic, run by Gynuity Health Projects at 2 sites in Ukraine.
Trial summary
The study will examine how a simplified outpatient medical abortion procedure using mifepristone and misoprostol, with the option to take mifepristone at a place of woman's choosing, works in Ukraine. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion, Therapeutic
- What is being tested?
- Mifepristone and Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesUkraine
- Study dates
- 23 Nov 2016to 30 Jun 2017
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Have an intrauterine pregnancy consistent with gestational age less than 71 days;
- Be able to understand and willing to sign a consent form;
- Be eligible for medical abortion according to the clinician's assessment;
- Be able to return to the clinic and able to contact study staff or emergency medical services, if needed;
- Be willing to provide an address and/or telephone number for purposes of follow-up;
- Agree to comply with the study procedures and visit schedule.
Who cannot join
- Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
- Chronic renal failure;
- Concurrent long-term corticosteroid therapy;
- History of allergy to mifepristone, or misoprostol or another prostaglandin;
- History of hemorrhagic disorders or concurrent anticoagulant therapy;
- History of inherited porphyrias;
- Intrauterine device in place (must be removed before mifepristone is administered).
Trial locations and contacts
2 sites in 1 country.
Ukraine2 sites
Lviv Municipal Women's Consultation No. 2
Lviv
Vinnitsa Regional Clinical Hospital
Vinnitsa
About this study
Official title: Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine: A Demonstration Study of 800 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 70 Days Gestation
The study will examine how a simplified outpatient medical abortion procedure using mifepristone and misoprostol, with the option to take mifepristone at a place of woman's choosing, works in Ukraine. The investigators intend to demonstrate the efficacy of oral administration of 200 mg mifepristone and buccal administration of 800 mcg misoprostol with gestations through 70 days, as well as the acceptability of this method.
- Conditions
- Abortion, Therapeutic
- Being tested
- Mifepristone, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Women seeking medical abortion will be offered the option to take mifepristone at home
MisoprostolDrug
Women seeking medical abortion will be offered the option to take misoprostol at home. Misoprostol will be administered buccally.
| Study group | Role | What they receive |
|---|---|---|
| Simplified medical abortion | Experimental | Women seeking medical abortion will be offered the option self-administering the medications, mifepristone and misoprostol at home. Receives: Drug: Mifepristone; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful abortion
Measured: 2 weeks after mifepristone administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start23 Nov 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, TherapeuticStudies 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
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Charitable Foundation Women Health & Family Planning
- Responsible party
- Sponsor
- Investigators
- Ingrida Platais, MS, Principal investigator, Gynuity Health ProjectsTamar Tsereteli, MD, MSc, PhD, Principal investigator, Gynuity Health ProjectsBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsGalyna Maystruk, MD, Study director, Charitable Foundation Women Health & Family Planning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981030
- Sponsor's protocol ID
- 1037
- Status last verified
- Jun 2018
- First submitted
- 16 Nov 2016
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of a Simplified Medical Abortion Service Delivery in Western Ukraine: A Demonstration Study of 800 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 70 Days Gestation
- ClinicalTrials.gov ID
- NCT02981030
- Acronym / sponsor ID
- 1037
- Conditions
- Abortion, Therapeutic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Charitable Foundation Women Health & Family Planning
- Study start
- 23 Nov 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 2 Dec 2016 (estimated)
- 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.
The study will examine how a simplified outpatient medical abortion procedure using mifepristone and misoprostol, with the option to take mifepristone at a place of woman's choosing, works in Ukraine. The investigators intend to demonstrate the efficacy of oral administration of 200 mg mifepristone and buccal administration of 800 mcg misoprostol with gestations through 70 days, as well as the acceptability of this method.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simplified medical abortion | Experimental | Drug: Mifepristone, Drug: MisoprostolWomen seeking medical abortion will be offered the option self-administering the medications, mifepristone and misoprostol at home. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Have an intrauterine pregnancy consistent with gestational age less than 71 days;
- Be able to understand and willing to sign a consent form;
- Be eligible for medical abortion according to the clinician's assessment;
- Be able to return to the clinic and able to contact study staff or emergency medical services, if needed;
- Be willing to provide an address and/or telephone number for purposes of follow-up;
Key exclusion criteria (7 listed)
- Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass;
- Chronic renal failure;
- Concurrent long-term corticosteroid therapy;
- History of allergy to mifepristone, or misoprostol or another prostaglandin;
- History of hemorrhagic disorders or concurrent anticoagulant therapy;
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 |
|---|---|---|
| MifepristoneWomen seeking medical abortion will be offered the option to take mifepristone at home | Drug | Simplified medical abortion |
| MisoprostolWomen seeking medical abortion will be offered the option to take misoprostol at home. Misoprostol will be administered buccally. | Drug | Simplified medical abortion |
Primary outcome
Rate of successful abortion
Time frame: 2 weeks after mifepristone administration
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 18 Jun 2018.
- 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.
Ingrida Platais, MS principal investigator
Gynuity Health Projects
Tamar Tsereteli, MD, MSc, PhD principal investigator
Gynuity Health Projects
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
2 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 and Misoprostol in people with Abortion, Therapeutic, run by Gynuity Health Projects at 2 sites in Ukraine.
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 7 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 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ukraine. 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?
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?
Rate of successful abortion (time frame: 2 weeks after mifepristone administration). 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 18 Jun 2018.