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

Other Abortion Clinical Trial

Official title:

Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Ukraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415894
• Other study ID #: 1025
• Status: Completed
• Phase: N/A
• First received: April 2, 2015
• Last updated: July 21, 2016
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ukraine: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Other Abortion

Locations

Country	Name	City	State
Ukraine	Odessa Regional Hospital	Odessa
Ukraine	Poltava City Maternity Hospital	Poltava
Ukraine	Vinnitsa Regional Hospital	Vinnitsa

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful abortion		15 hours after start of misoprostol induction	Yes