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

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ClinicalTrials.gov Identifier: NCT02018796
Recruitment Status : Completed
First Posted : December 23, 2013
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Tracking Information
First Submitted Date December 10, 2013
First Posted Date December 23, 2013
Last Update Posted Date August 13, 2015
Study Start Date October 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2013)
Rate of successful abortion [ Time Frame: 2 weeks after mifepristone administration ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02018796 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 17, 2013)
Satisfaction with method [ Time Frame: 2 weeks or up to 30 days after mifepristone administration ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 17, 2013)
  • 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 ]
  • Side effects [ Time Frame: 2 weeks after mifepristone administration ]
  • Acceptability of the side effects and of sublingual administration [ Time Frame: 2 weeks after mifepristone administration ]
  • Complications, including heavy bleeding or infection requiring additional treatment [ Time Frame: 2 weeks after mifepristone administration ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days' Gestation in Kazakhstan
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
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?
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women seeking an abortion at participating study sites
Condition Complete Abortion
Intervention Drug: Mifepristone, misoprostol
200 mifepristone, followed 24 to 48 hours later by 600 mcg misoprostol
Study Groups/Cohorts 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.
Intervention: Drug: Mifepristone, misoprostol
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 11, 2015)
290
Original Estimated Enrollment
 (submitted: December 17, 2013)
350
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Kazakhstan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02018796
Other Study ID Numbers 1011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Gynuity Health Projects
Study Sponsor Gynuity Health Projects
Collaborators Not Provided
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
PRS Account Gynuity Health Projects
Verification Date August 2015