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

NCT02018796 | Completed

• 1 other identifier: 1011
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 4

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

Conditions

Complete Abortion

Outcome Measures

Primary Outcomes (1)

• Rate of successful abortion

  2 weeks after mifepristone administration

Secondary Outcomes (1)

• Satisfaction with method

  2 weeks or up to 30 days after mifepristone administration

Other Outcomes (4)

• 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

Study Arms (1)

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

Interventions

Mifepristone, misoprostol DRUG

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

Women seeking medical abortion

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women seeking an abortion at participating study sites

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gynuity Health Projects: lead

Study Sites (4)

Almaty City Policlinic No. 19

Almaty, Kazakhstan

Location

Almaty City Policlinic No. 9

Almaty, Kazakhstan

Location

Consultation and Diagnostics Department of the City Maternity House

Astana, Kazakhstan

Location

Consultation and Diagnostics Department of the Regional Perinatal Center No. 2

Astana, Kazakhstan

Location

Related Publications (1)

• 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.

  PMID: 27352735 DERIVED

Related Links

• Kazakhstan Association on Sexual and Reproductive Health

MeSH Terms

Interventions

Mifepristone; Misoprostol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Galina Grebennikova, MD

  Kazakhstan Association on Sexual and Reproductive Health

  STUDY DIRECTOR

• Tamar Tsereteli, MD, MSc, PhD

  Gynuity Health Projects

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 23, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

KA (4)