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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date April 2, 2015
First Posted Date April 14, 2015
Last Update Posted Date July 22, 2016
Study Start Date April 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 9, 2015)
Rate of successful abortion [ Time Frame: 15 hours after start of misoprostol induction ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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 Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women with mid-trimester pregnancy seeking abortion
Condition Other Abortion
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Platais I, Tsereteli T, Maystruk G, Kurbanbekova D, Winikoff B. A prospective study of mifepristone and unlimited dosing of sublingual misoprostol for termination of second-trimester pregnancy in Uzbekistan and Ukraine. BMJ Sex Reprod Health. 2019 Jun 4. pii: bmjsrh-2018-200167. doi: 10.1136/bmjsrh-2018-200167. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 21, 2016)
172
Original Estimated Enrollment
 (submitted: April 9, 2015)
170
Actual Study Completion Date April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number NCT02415894
Other Study ID Numbers 1025
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Gynuity Health Projects
Original Responsible Party Same as current
Current Study Sponsor Gynuity Health Projects
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Tamar Tsereteli, MD, PhD Gynuity Health Projects
Study Director: Galina Maistruk, MD Woman Health and Family Planning Charitable Foundation
PRS Account Gynuity Health Projects
Verification Date July 2016