Clinical trial NCT02018796: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complete Abortion
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 290
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women seeking an abortion at participating study sites

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?


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).

Primary outcomes:
measure: Rate of successful abortion
timeFrame: 2 weeks after mifepristone administration
Secondary outcomes:
measure: Satisfaction with method
timeFrame: 2 weeks or up to 30 days after mifepristone administration
Other outcomes:
measure: Number of days missed work/school for women choosing mifepristone administration outside the clinic and those who choose its administration at the clinic
timeFrame: 2 weeks after mifepristone administration
measure: Side effects
timeFrame: 2 weeks after mifepristone administration
measure: Acceptability of the side effects and of sublingual administration
timeFrame: 2 weeks after mifepristone administration
measure: Complications, including heavy bleeding or infection requiring additional treatment
timeFrame: 2 weeks after mifepristone administration
Locations:
city: Almaty
country: Kazakhstan
facility: Almaty City Policlinic No. 19
city: Almaty
country: Kazakhstan
facility: Almaty City Policlinic No. 9
city: Astana
country: Kazakhstan
facility: Consultation and Diagnostics Department of the City Maternity House
city: Astana
country: Kazakhstan
facility: Consultation and Diagnostics Department of the Regional Perinatal Center No. 2
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Almaty City Policlinic No 19, Almaty, Kazakhstan
name: Mariya Bashkirova, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Almaty City Policlinic No. 9, Almaty, Kazakhstan
name: Tina Kan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Consultation and Diagnostics Department, Regional Perinatal Center, Astana, Kazakhstan
name: Gulnar Mukazhanova, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Consultation and Diagnostics Department, City Maternity House, Astana, Kazakhstan
name: Oksana Kolyadinova, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kazakhstan Association on Sexual and Reproductive Health
name: Galina Grebennikova, MD
role: STUDY_DIRECTOR
affiliation: Gynuity Health Projects
name: Tamar Tsereteli, MD, MSc, PhD
role: STUDY_DIRECTOR
References:
citation: 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.