Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days' Gestation in Kazakhstan
NCT ID: NCT02018796
Last Updated: 2015-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
290 participants
OBSERVATIONAL
2013-10-31
2014-12-31
Brief Summary
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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?
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Mifepristone, misoprostol
200 mifepristone, followed 24 to 48 hours later by 600 mcg misoprostol
Interventions
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Mifepristone, misoprostol
200 mifepristone, followed 24 to 48 hours later by 600 mcg misoprostol
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
FEMALE
Yes
Sponsors
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Gynuity Health Projects
OTHER
Responsible Party
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Principal Investigators
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Beverly Winikoff, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Mariya Bashkirova, MD
Role: PRINCIPAL_INVESTIGATOR
Almaty City Policlinic No 19, Almaty, Kazakhstan
Tina Kan, MD
Role: PRINCIPAL_INVESTIGATOR
Almaty City Policlinic No. 9, Almaty, Kazakhstan
Gulnar Mukazhanova, MD
Role: PRINCIPAL_INVESTIGATOR
Consultation and Diagnostics Department, Regional Perinatal Center, Astana, Kazakhstan
Oksana Kolyadinova, MD
Role: PRINCIPAL_INVESTIGATOR
Consultation and Diagnostics Department, City Maternity House, Astana, Kazakhstan
Galina Grebennikova, MD
Role: STUDY_DIRECTOR
Kazakhstan Association on Sexual and Reproductive Health
Tamar Tsereteli, MD, MSc, PhD
Role: STUDY_DIRECTOR
Gynuity Health Projects
Locations
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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, , Kazakhstan
Countries
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References
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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.
Related Links
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Kazakhstan Association on Sexual and Reproductive Health
Other Identifiers
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1011
Identifier Type: -
Identifier Source: org_study_id
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