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Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Ukraine

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ClinicalTrials.gov Identifier: NCT02415894
Recruitment Status : Completed
First Posted : April 14, 2015
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Study Description
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Brief Summary:
The goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Ukraine.

Condition or disease
Other Abortion

Study Design
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Study Type : Observational
Actual Enrollment : 172 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Ukraine
Study Start Date : April 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Rate of successful abortion [ Time Frame: 15 hours after start of misoprostol induction ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with mid-trimester pregnancy seeking abortion
Criteria

Inclusion Criteria:

  • Having an ongoing pregnancy of 13-22 weeks gestation
  • Be willing to undergo surgical completion if necessary
  • Have no contraindications to study procedures, according to provider
  • Be willing and able to consent to participate in the study
  • Be willing to follow study procedures

Exclusion Criteria:

  • Known allergy to mifepristone or misoprostol/prostaglandin
  • Any contraindications to vaginal delivery, including placenta previa
  • Unable to provide consent
Contacts and Locations
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To 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): NCT02415894


Locations
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Ukraine
Odessa Regional Hospital
Odessa, Ukraine
Poltava City Maternity Hospital
Poltava, Ukraine
Vinnitsa Regional Hospital
Vinnitsa, Ukraine
Sponsors and Collaborators
Gynuity Health Projects
Investigators
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Study Director: Tamar Tsereteli, MD, PhD Gynuity Health Projects
Study Director: Galina Maistruk, MD Woman Health and Family Planning Charitable Foundation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02415894     History of Changes
Other Study ID Numbers: 1025
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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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