Abortion in Second TrimesterNCT02235155
Mifepristone and Misoprostol for Midtrimester Termination of Pregnancy in Uzbekistan
An observational study of Abortion in Second Trimester, run by Gynuity Health Projects at 3 sites in Uzbekistan.
Trial summary
The primary goal is to examine the efficacy and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Uzbekistan. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion in Second Trimester
- How many people
- 135 participants
- Where
- 3 sitesUzbekistan
- Study dates
- Sep 2014to Nov 2015
- 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: Pregnant women
Who may be able to join
- Meet legal criteria to obtain abortion
- Have an ongoing pregnancy of 13-22 weeks gestation
- Be willing to undergo a surgical completion if necessary
- Have no contraindications to study procedures, according to provider
- Be willing and able to consent to procedure, either by reading consent document or by having consent document read to her
- Be willing to follow study procedures
Who cannot join
- Known previous transmural uterine incision
- Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- Any contraindications to vaginal delivery, including placenta previa
Trial locations and contacts
3 sites in 1 country.
Uzbekistan3 sites
Bukhara Maternity House No. 1
Bukhara
Samarkand Perinatal Center
Samarkand
Clinic No. 2, Tashkent Medical Academy
Tashkent
About this study
Official title: Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Uzbekistan
The primary goal is to examine the efficacy and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Uzbekistan.
- Conditions
- Abortion in Second Trimester
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women of 13-22 weeks gestation | Pregnant women of 13-22 weeks gestation will receive 200 mg mifepristone followed 24-48 hours later by 400 mcg sublingual misoprostol every three hours until complete expulsion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of abortions that are complete as a measure of efficacy
It is a proportion that specifies how many abortions out of all initiated abortions are complete without recourse to surgical intervention within 15 hours after the start of misoprostol administration.
Measured: At 15 hours after the start of misoprostol administration
Secondary outcomes (8)
Interval of time between induction with misoprostol to complete abortion
It is the length of time between the administration of the first dose of misoprostol and complete abortion.
Measured: Every 3 hours from the start of misoprostol administration until complete abortion
Women's satisfaction with the method
It is a scale that assesses the level of a woman's satisfaction with the procedure.
Measured: At discharge, up to 5 days after enrollment
Side effects experienced by women
It is a brief questionnaire that records all side effects experienced by women.
Measured: Every 3 hours from the start of misoprostol administration until complete abortion
Pain experienced by women
It is a scale that assesses the acceptability of pain experienced by the woman.
Measured: At the time of discharge, up to 5 days after enrollment
Complications during induction and after discharge
It is a record of complications and their treatment during induction and up to 1 month after discharge.
Measured: Every 3 hours from the start of misoprostol administration, up to 1 month after discharge
Women's perception of acceptability of the procedure
It is a scale that assesses the acceptability of the procedure for the woman.
Measured: At discharge, up to 5 days after enrollment
Provider's perception of acceptability of the method
It is a questionnaire that assesses the acceptability of the method for the provider.
Measured: At study completion, up to 2 years after study enrollment commences
Total dose of misoprostol administered
Count of the total dose of misoprostol administered from the first dose to complete abortion.
Measured: Every 3 hours from start of misoprostol administration to complete abortion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2015
- Study completionNov 2015
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 Abortion in Second TrimesterStudies 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dilfuza Kurbanbekova, PhD, MD, Principal investigator, Women's Wellness Center, UzbekistanTamar Tsereteli, PhD, MD, Principal investigator, Gynuity Health ProjectsBeverly Winikoff, MD, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235155
- Sponsor's protocol ID
- 1017
- Status last verified
- Jan 2016
- First submitted
- 29 Aug 2014
- Last updated
- 14 Jan 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 14 Jan 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 Uzbekistan
- ClinicalTrials.gov ID
- NCT02235155
- Acronym / sponsor ID
- 1017
- Conditions
- Abortion in Second Trimester
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Sep 2014 (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 primary goal is to examine the efficacy and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Uzbekistan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women of 13-22 weeks gestation | – | –Pregnant women of 13-22 weeks gestation will receive 200 mg mifepristone followed 24-48 hours later by 400 mcg sublingual misoprostol every three hours until complete expulsion. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (6 listed)
- Meet legal criteria to obtain abortion
- Have an ongoing pregnancy of 13-22 weeks gestation
- Be willing to undergo a surgical completion if necessary
- Have no contraindications to study procedures, according to provider
- Be willing and able to consent to procedure, either by reading consent document or by having consent document read to her
Key exclusion criteria (3 listed)
- Known previous transmural uterine incision
- Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
- Any contraindications to vaginal delivery, including placenta previa
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
Proportion of abortions that are complete as a measure of efficacy
Time frame: At 15 hours after the start of misoprostol administration
It is a proportion that specifies how many abortions out of all initiated abortions are complete without recourse to surgical intervention within 15 hours after the start of misoprostol administration.
8 secondary outcomes
Interval of time between induction with misoprostol to complete abortion
Time frame: Every 3 hours from the start of misoprostol administration until complete abortion
Women's satisfaction with the method
Time frame: At discharge, up to 5 days after enrollment
Side effects experienced by women
Time frame: Every 3 hours from the start of misoprostol administration until complete abortion
Pain experienced by women
Time frame: At the time of discharge, up to 5 days after enrollment
Complications during induction and after discharge
Time frame: Every 3 hours from the start of misoprostol administration, up to 1 month after discharge
Women's perception of acceptability of the procedure
Time frame: At discharge, up to 5 days after enrollment
Provider's perception of acceptability of the method
Time frame: At study completion, up to 2 years after study enrollment commences
Total dose of misoprostol administered
Time frame: Every 3 hours from start of misoprostol administration to complete abortion
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 14 Jan 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.
Related trials for Abortion in Second Trimester
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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.
Dilfuza Kurbanbekova, PhD, MD principal investigator
Women's Wellness Center, Uzbekistan
Tamar Tsereteli, PhD, MD principal investigator
Gynuity Health Projects
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
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 Abortion in Second Trimester, run by Gynuity Health Projects at 3 sites in Uzbekistan.
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 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 14 Jan 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 Uzbekistan. 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?
Proportion of abortions that are complete as a measure of efficacy (time frame: At 15 hours after the start of misoprostol administration). 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 NCT02235155, 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 14 Jan 2016.