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History of Changes for Study: NCT02415894
Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Ukraine
Latest version (submitted July 21, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 9, 2015 None (earliest Version on record)
2 March 10, 2016 Study Status
3 July 21, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT02415894
Submitted Date:  April 9, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: 1025
Brief Title: Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Ukraine
Official Title: Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Ukraine
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2015
Overall Status: Recruiting
Study Start: April 2015
Primary Completion: April 2016 [Anticipated]
Study Completion: April 2016 [Anticipated]
First Submitted: April 2, 2015
First Submitted that
Met QC Criteria:
April 9, 2015
First Posted: April 14, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 9, 2015
Last Update Posted: April 14, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Gynuity Health Projects
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Other Abortion
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 170 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Rate of successful abortion
[ Time Frame: 15 hours after start of misoprostol induction ]

Open or close this module Eligibility
Study Population: Women with mid-trimester pregnancy seeking abortion
Sampling Method: Non-Probability Sample
Minimum Age:
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: Yes
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
Open or close this module Contacts/Locations
Central Contact Person: Ingrida Platais, MS
Telephone: 12124481230
Email: iplatais@gynuity.org
Study Officials: Tamar Tsereteli, MD, PhD
Study Director
Gynuity Health Projects
Galina Maistruk, MD
Study Director
Woman Health and Family Planning Charitable Foundation
Locations: Ukraine
Odessa Regional Hospital
[Recruiting]
Odessa, Ukraine
Contact:Contact: Svetlana Posohova, MD, PhD
Poltava City Maternity Hospital
[Recruiting]
Poltava, Ukraine
Contact:Contact: Anna Shkodenko, MD
Vinnitsa Regional Hospital
[Recruiting]
Vinnitsa, Ukraine
Contact:Contact: Inna Kukuruza, MD
Open or close this module IPDSharing
Plan to Share IPD:
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Links:
Available IPD/Information:

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