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

Complete Abortion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02018796
• Other study ID #: 1011
• Status: Completed
• Phase: N/A
• First received: December 10, 2013
• Last updated: August 11, 2015
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kazakhstan: Ministry of Public Health
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complete Abortion

Intervention

Drug:
• Mifepristone, misoprostol
200 mifepristone, followed 24 to 48 hours later by 600 mcg misoprostol

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Side effects		2 weeks after mifepristone administration	No
Other	Acceptability of the side effects and of sublingual administration		2 weeks after mifepristone administration	No
Other	Complications, including heavy bleeding or infection requiring additional treatment		2 weeks after mifepristone administration	No
Primary	Rate of successful abortion		2 weeks after mifepristone administration	No
Secondary	Satisfaction with method		2 weeks or up to 30 days after mifepristone administration	No

External Links

•   Kazakhstan Association on Sexual and Reproductive Health