Other AbortionNCT02415894
Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Ukraine
An observational study of Other Abortion, run by Gynuity Health Projects at 3 sites in Ukraine.
Trial summary
The goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Ukraine. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Other Abortion
- How many people
- 172 participants
- Where
- 3 sitesUkraine
- Study dates
- Apr 2015to Apr 2016
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women with mid-trimester pregnancy seeking abortion
Who may be able to join
- Having an ongoing pregnancy of 13-22 weeks gestation
- Be willing to undergo surgical completion if necessary
- Have no contraindications to study procedures, according to provider
- Be willing and able to consent to participate in the study
- Be willing to follow study procedures
Who cannot join
- Known allergy to mifepristone or misoprostol/prostaglandin
- Any contraindications to vaginal delivery, including placenta previa
- Unable to provide consent
Trial locations and contacts
3 sites in 1 country.
Ukraine3 sites
Odessa Regional Hospital
Odesa
Poltava City Maternity Hospital
Poltava
Vinnitsa Regional Hospital
Vinnitsa
About this study
Official title: Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Ukraine
The goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Ukraine.
- Conditions
- Other Abortion
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful abortion
Measured: 15 hours after start of misoprostol induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other AbortionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamar Tsereteli, MD, PhD, Study director, Gynuity Health ProjectsGalina Maistruk, MD, Study director, Woman Health and Family Planning Charitable Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415894
- Sponsor's protocol ID
- 1025
- Status last verified
- Jul 2016
- First submitted
- 2 Apr 2015
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Platais I, Tsereteli T, Maystruk G, Kurbanbekova D, Winikoff B. A prospective study of mifepristone and unlimited dosing of sublingual misoprostol for termination of second-trimester pregnancy in Uzbekistan and Ukraine. BMJ Sex Reprod Health. 2019 Jun 4:bmjsrh-2018-200167. doi: 10.1136/bmjsrh-2018-200167. Online ahead of print.
PubMed 31164394
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Ukraine
- ClinicalTrials.gov ID
- NCT02415894
- Acronym / sponsor ID
- 1025
- Conditions
- Other Abortion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 14 Apr 2015 (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 goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Ukraine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with mid-trimester pregnancy seeking abortion
Key inclusion criteria (5 listed)
- Having an ongoing pregnancy of 13-22 weeks gestation
- Be willing to undergo surgical completion if necessary
- Have no contraindications to study procedures, according to provider
- Be willing and able to consent to participate in the study
- Be willing to follow study procedures
Key exclusion criteria (3 listed)
- Known allergy to mifepristone or misoprostol/prostaglandin
- Any contraindications to vaginal delivery, including placenta previa
- Unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of successful abortion
Time frame: 15 hours after start of misoprostol induction
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 22 Jul 2016.
- Derived from this study: PubMed 31164394Platais I, Tsereteli T, Maystruk G, Kurbanbekova D, Winikoff B. A prospective study of mifepristone and unlimited dosing of sublingual misoprostol for termination of second-trimester pregnancy in Uzbekistan and Ukraine. BMJ Sex Reprod Health. 2019 Jun 4:bmjsrh-2018-200167. doi: 10.1136/bmjsrh-2018-200167. Online ahead of print.
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.
Tamar Tsereteli, MD, PhD study director
Gynuity Health Projects
Galina Maistruk, MD study director
Woman Health and Family Planning Charitable Foundation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Other Abortion, run by Gynuity Health Projects at 3 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 5 inclusion and 3 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 22 Jul 2016. 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 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.
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: 15 hours after start of misoprostol induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02415894, which also lists 1 linked publication.
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 22 Jul 2016.