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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone, misoprostol | Drug | 200 mifepristone, followed 24 to 48 hours later by 600 mcg misoprostol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful abortion | 2 weeks after mifepristone administration |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with method | 2 weeks or up to 30 days after mifepristone administration |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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Women seeking an abortion at participating study sites
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almaty City Policlinic No. 19 | Almaty | Kazakhstan | ||||
| Almaty City Policlinic No. 9 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27352735 | Derived | 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. |
| Label | URL |
|---|---|
| Kazakhstan Association on Sexual and Reproductive Health | View source |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 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 |
| 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 |
| D011083 |
| Polycyclic Compounds |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |