Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days' Gestation in Kazakhstan

August 11, 2015 updated by: Gynuity Health Projects

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:

  1. 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?
  2. Is medical abortion procedure consisting of two visits acceptable to women in Kazakhstan?
  3. Are the side effects associated with sublingual use of misoprostol acceptable to women?
  4. When given a choice, do women prefer to take mifepristone in the clinic or at a place of their choosing?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Almaty, Kazakhstan
        • Almaty City Policlinic No. 19
      • Almaty, Kazakhstan
        • Almaty City Policlinic No. 9
      • Astana, Kazakhstan
        • Consultation and Diagnostics Department of the City Maternity House
      • Astana, Kazakhstan
        • Consultation and Diagnostics Department of the Regional Perinatal Center No. 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women seeking an abortion at participating study sites

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Mifepristone, misoprostol
200 mifepristone, followed 24 to 48 hours later by 600 mcg misoprostol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rate of successful abortion
Time Frame: 2 weeks after mifepristone administration
2 weeks after mifepristone administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Satisfaction with method
Time Frame: 2 weeks or up to 30 days after mifepristone administration
2 weeks or up to 30 days after mifepristone administration

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Number of days missed work/school for women choosing mifepristone administration outside the clinic and those who choose its administration at the clinic
Time Frame: 2 weeks after mifepristone administration
2 weeks after mifepristone administration
Side effects
Time Frame: 2 weeks after mifepristone administration
2 weeks after mifepristone administration
Acceptability of the side effects and of sublingual administration
Time Frame: 2 weeks after mifepristone administration
2 weeks after mifepristone administration
Complications, including heavy bleeding or infection requiring additional treatment
Time Frame: 2 weeks after mifepristone administration
2 weeks after mifepristone administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gynuity Health Projects

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Beverly Winikoff, MD, PhD, Gynuity Health Projects
  • Principal Investigator: Mariya Bashkirova, MD, Almaty City Policlinic No 19, Almaty, Kazakhstan
  • Principal Investigator: Tina Kan, MD, Almaty City Policlinic No. 9, Almaty, Kazakhstan
  • Principal Investigator: Gulnar Mukazhanova, MD, Consultation and Diagnostics Department, Regional Perinatal Center, Astana, Kazakhstan
  • Principal Investigator: Oksana Kolyadinova, MD, Consultation and Diagnostics Department, City Maternity House, Astana, Kazakhstan
  • Study Director: Galina Grebennikova, MD, Kazakhstan Association on Sexual and Reproductive Health
  • Study Director: Tamar Tsereteli, MD, MSc, PhD, Gynuity Health Projects

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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