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

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: Completed
• Conditions: Complete Abortion
• Intervention / Treatment: Drug: Mifepristone, misoprostol

• Study Type: Observational
• Enrollment (Actual): 290

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of successful abortion	2 weeks after mifepristone administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Satisfaction with method	2 weeks or up to 30 days after mifepristone administration

Other Outcome Measures

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	2 weeks after mifepristone administration
Side effects	2 weeks after mifepristone administration
Acceptability of the side effects and of sublingual administration	2 weeks after mifepristone administration
Complications, including heavy bleeding or infection requiring additional treatment	2 weeks after mifepristone administration

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General 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.

Helpful Links

• Kazakhstan Association on Sexual and Reproductive Health

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (ESTIMATE): December 23, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 11, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Ulcer Agents; Contraceptives, Oral, Synthetic; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Misoprostol; Mifepristone
• Other Study ID Numbers: 1011