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

NCT02018796 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 290

Last updated 2015-08-13

No results posted yet for this study

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?

Conditions

  • Complete Abortion

Interventions

DRUG

Mifepristone, misoprostol

200 mifepristone, followed 24 to 48 hours later by 600 mcg misoprostol

Sponsors & Collaborators

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Beverly Winikoff, MD, PhD · Gynuity Health Projects

  • Mariya Bashkirova, MD · Almaty City Policlinic No 19, Almaty, Kazakhstan

  • Tina Kan, MD · Almaty City Policlinic No. 9, Almaty, Kazakhstan

  • Gulnar Mukazhanova, MD · Consultation and Diagnostics Department, Regional Perinatal Center, Astana, Kazakhstan

  • Oksana Kolyadinova, MD · Consultation and Diagnostics Department, City Maternity House, Astana, Kazakhstan

  • Galina Grebennikova, MD · Kazakhstan Association on Sexual and Reproductive Health

  • Tamar Tsereteli, MD, MSc, PhD · Gynuity Health Projects

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Kazakhstan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02018796 on ClinicalTrials.gov