г. Алматы, 050012 ул. Жамбыла 114/85, офис 227/1

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

Brief 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. 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?
Condition or disease  Intervention/treatment 
Complete Abortion Drug: Mifepristone, misoprostol

 

Study Design
Study Type  : Observational
Actual Enrollment  : 290 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date  : October 2013
Primary Completion Date  : December 2014
Study Completion Date  : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
Group/Cohort  Intervention/treatment 
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

 

Outcome Measures

 

Primary Outcome Measures  :

  1. Rate of successful abortion [ Time Frame: 2 weeks after mifepristone administration ]

Secondary Outcome Measures  :

  1. Satisfaction with method [ Time Frame: 2 weeks or up to 30 days after mifepristone administration ]

Other Outcome Measures:

  1. 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. Side effects [ Time Frame: 2 weeks after mifepristone administration ]
  3. Acceptability of the side effects and of sublingual administration [ Time Frame: 2 weeks after mifepristone administration ]
  4. Complications, including heavy bleeding or infection requiring additional treatment [ Time Frame: 2 weeks after mifepristone administration ]
Eligibility Criteria

Information from the National Library of MedicineChoosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study: Child, Adult, Senior
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Sampling Method: Non-Probability Sample
Study Population
Women seeking an abortion at participating study sites
Criteria

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).
Contacts and Locations

Information from the National Library of MedicineTo learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018796

 

Locations
Kazakhstan
Almaty City Policlinic No. 19
Almaty, Kazakhstan
Almaty City Policlinic No. 9
Almaty, Kazakhstan
Consultation and Diagnostics Department of the City Maternity House
Astana, Kazakhstan
Consultation and Diagnostics Department of the Regional Perinatal Center No. 2
Astana, Kazakhstan
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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
More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02018796     History of Changes
Other Study ID Numbers: 1011
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

Additional relevant MeSH terms:

Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
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