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:
- 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?
- Is medical abortion procedure consisting of two visits acceptable to women in Kazakhstan?
- Are the side effects associated with sublingual use of misoprostol acceptable to women?
- When given a choice, do women prefer to take mifepristone in the clinic or at a place of their choosing?
| Condition or disease | Intervention/treatment |
|---|---|
| Complete Abortion | Drug: Mifepristone, misoprostol |
| Study Type : | Observational |
| Actual Enrollment : | 290 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| 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 Start Date : | October 2013 |
| Primary Completion Date : | December 2014 |
| Study Completion Date : | December 2014 |
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| Group/Cohort | Intervention/treatment |
|---|---|
| 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
200 mifepristone, followed 24 to 48 hours later by 600 mcg misoprostol
|
Primary Outcome Measures :
- Rate of successful abortion [ Time Frame: 2 weeks after mifepristone administration ]
Secondary Outcome Measures :
- Satisfaction with method [ Time Frame: 2 weeks or up to 30 days after mifepristone administration ]
Other Outcome Measures:
- Number of days missed work/school for women choosing mifepristone administration outside the clinic and those who choose its administration at the clinic [ Time Frame: 2 weeks after mifepristone administration ]
- Side effects [ Time Frame: 2 weeks after mifepristone administration ]
- Acceptability of the side effects and of sublingual administration [ Time Frame: 2 weeks after mifepristone administration ]
- Complications, including heavy bleeding or infection requiring additional treatment [ Time Frame: 2 weeks after mifepristone administration ]
Information from the National Library of MedicineChoosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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).
Information from the National Library of MedicineTo learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018796
| 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, Kazakhstan | |
| Principal Investigator: | 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 | |
| Study Director: | Galina Grebennikova, MD | Kazakhstan Association on Sexual and Reproductive Health | |
| Study Director: | Tamar Tsereteli, MD, MSc, PhD | Gynuity Health Projects |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gynuity Health Projects |
| ClinicalTrials.gov Identifier: | NCT02018796 History of Changes |
| Other Study ID Numbers: | 1011 |
| First Posted: | December 23, 2013 Key Record Dates |
| Last Update Posted: | August 13, 2015 |
| Last Verified: | August 2015 |
Additional relevant MeSH terms:
| Misoprostol Mifepristone Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Oxytocics Abortifacient Agents, Steroidal |
Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents |