Complete AbortionNCT02018796
Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days' Gestation in Kazakhstan
An observational study of Complete Abortion, run by Gynuity Health Projects at 4 sites in Kazakhstan.
Trial summary
The study will be conducted in 4 sites and 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 Kazakhstan. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complete Abortion
- What is being tested?
- Mifepristone, misoprostol
- How many people
- 290 participants
- Where
- 4 sitesKazakhstan
- Study dates
- Oct 2013to Dec 2014
- 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 seeking an abortion at participating study sites
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
4 sites in 1 country.
Kazakhstan4 sites
Almaty City Policlinic No. 19
Almaty
Almaty City Policlinic No. 9
Almaty
Consultation and Diagnostics Department of the City Maternity House
Astana
Consultation and Diagnostics Department of the Regional Perinatal Center No. 2
Astana
About this study
Official title: Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Kazakhstan: A Study of 600 µg Sublingual Misoprostol Following 200 mg Mifepristone for Abortion up to 70 Days Gestation
The study will be conducted in 4 sites and 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 Kazakhstan. The investigators intend to demonstrate the efficacy of oral administration of 200 mg mifepristone and sublingual administration of 600 µg misoprostol with gestations through 70 days, as well as the acceptability of this method. Research questions include:
- What is the efficacy of regimen of 200 mg mifepristone, followed 24 to 48 hours later by 600 µg sublingual misoprostol and used in gestations of up to 70 days?
- Is medical abortion procedure consisting of two visits acceptable to women in Kazakhstan?
- Are the side effects associated with sublingual use of misoprostol acceptable to women?
- When given a choice, do women prefer to take mifepristone in the clinic or at a place of their choosing?
- Conditions
- Complete Abortion
- Being tested
- Mifepristone, misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone, misoprostolDrug
200 mifepristone, followed 24 to 48 hours later by 600 mcg misoprostol
| Study group | Role | What they receive |
|---|---|---|
| Women seeking medical abortion | Women with pregnancies less than 71 days gestation seeking medical abortion. Women who choose to participate in the study will be administered 200 mifepristone, followed 24 to 48 hours later by 600 mcg misoprostol. Receives: Drug: Mifepristone, 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
Secondary outcomes (1)
Satisfaction with method
Measured: 2 weeks or up to 30 days 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 posted23 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
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 Complete 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, PhD, Principal investigator, Gynuity Health ProjectsMariya Bashkirova, MD, Principal investigator, Almaty City Policlinic No 19, Almaty, KazakhstanTina Kan, MD, Principal investigator, Almaty City Policlinic No. 9, Almaty, KazakhstanGulnar Mukazhanova, MD, Principal investigator, Consultation and Diagnostics Department, Regional Perinatal Center, Astana, KazakhstanOksana Kolyadinova, MD, Principal investigator, Consultation and Diagnostics Department, City Maternity House, Astana, KazakhstanGalina Grebennikova, MD, Study director, Kazakhstan Association on Sexual and Reproductive HealthTamar Tsereteli, MD, MSc, PhD, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018796
- Sponsor's protocol ID
- 1011
- Status last verified
- Aug 2015
- First submitted
- 10 Dec 2013
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Platais I, Tsereteli T, Grebennikova G, Lotarevich T, Winikoff B. Prospective study of home use of mifepristone and misoprostol for medical abortion up to 10weeks of pregnancy in Kazakhstan. Int J Gynaecol Obstet. 2016 Sep;134(3):268-71. doi: 10.1016/j.ijgo.2016.02.018. Epub 2016 May 26.
PubMed 27352735
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Kazakhstan: A Study of 600 µg Sublingual Misoprostol Following 200 mg Mifepristone for Abortion up to 70 Days Gestation
- ClinicalTrials.gov ID
- NCT02018796
- Acronym / sponsor ID
- 1011
- Conditions
- Complete Abortion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Dec 2013 (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 be conducted in 4 sites and 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 Kazakhstan. The investigators intend to demonstrate the efficacy of oral administration of 200 mg mifepristone and sublingual administration of 600 µg misoprostol with gestations through 70 days, as well as the acceptability of this method. Research questions include:
- What is the efficacy of regimen of 200 mg mifepristone, followed 24 to 48 hours later by 600 µg sublingual misoprostol and used in gestations of up to 70 days?
- Is medical abortion procedure consisting of two visits acceptable to women in Kazakhstan?
- Are the side effects associated with sublingual use of misoprostol acceptable to women?
- When given a choice, do women prefer to take mifepristone in the clinic or at a place of their choosing?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women seeking medical abortion | – | Drug: Mifepristone, misoprostolWomen with pregnancies less than 71 days gestation seeking medical abortion. Women who choose to participate in the study will be administered 200 mifepristone, followed 24 to 48 hours later by 600 mcg misoprostol. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women seeking an abortion at participating study sites
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 |
|---|---|---|
| Mifepristone, misoprostol200 mifepristone, followed 24 to 48 hours later by 600 mcg misoprostol | Drug | Women seeking medical abortion |
Primary outcome
Rate of successful abortion
Time frame: 2 weeks after mifepristone administration
1 secondary outcome
Satisfaction with method
Time frame: 2 weeks or up to 30 days 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 13 Aug 2015.
- Derived from this study: PubMed 27352735Platais I, Tsereteli T, Grebennikova G, Lotarevich T, Winikoff B. Prospective study of home use of mifepristone and misoprostol for medical abortion up to 10weeks of pregnancy in Kazakhstan. Int J Gynaecol Obstet. 2016 Sep;134(3):268-71. doi: 10.1016/j.ijgo.2016.02.018. Epub 2016 May 26.
- Kazakhstan Association on Sexual and Reproductive HealthLink provided by the sponsor.
Related trials for Complete Abortion
Active, not recruitingObservational study
Assessment of Early Pregnancy MAB Completion
Pregnancy, Abortion Early
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.
Beverly Winikoff, MD, PhD principal investigator
Gynuity Health Projects
Mariya Bashkirova, MD principal investigator
Almaty City Policlinic No 19, Almaty, Kazakhstan
Tina Kan, MD principal investigator
Almaty City Policlinic No. 9, Almaty, Kazakhstan
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complete Abortion, run by Gynuity Health Projects at 4 sites in Kazakhstan.
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 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Kazakhstan. 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: 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?
On the ClinicalTrials.gov record for NCT02018796, 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 13 Aug 2015.