Mifepristone and Misoprostol for Midtrimester Termination of Pregnancy in Uzbekistan

NCT02235155 | Completed

• 1 other identifier: 1017
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 3

Brief Summary

The primary goal is to examine the efficacy and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Uzbekistan.

Conditions

Abortion in Second Trimester

Outcome Measures

Primary Outcomes (1)

• Proportion of abortions that are complete as a measure of efficacy

  It is a proportion that specifies how many abortions out of all initiated abortions are complete without recourse to surgical intervention within 15 hours after the start of misoprostol administration.

  At 15 hours after the start of misoprostol administration

Secondary Outcomes (8)

• Interval of time between induction with misoprostol to complete abortion

  Every 3 hours from the start of misoprostol administration until complete abortion

• Women's satisfaction with the method

  At discharge, up to 5 days after enrollment

• Side effects experienced by women

  Every 3 hours from the start of misoprostol administration until complete abortion

• Pain experienced by women

  At the time of discharge, up to 5 days after enrollment

• Complications during induction and after discharge

  Every 3 hours from the start of misoprostol administration, up to 1 month after discharge

Study Arms (1)

Pregnant women of 13-22 weeks gestation

Pregnant women of 13-22 weeks gestation will receive 200 mg mifepristone followed 24-48 hours later by 400 mcg sublingual misoprostol every three hours until complete expulsion.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

You may qualify if:

• Meet legal criteria to obtain abortion
• Have an ongoing pregnancy of 13-22 weeks gestation
• Be willing to undergo a surgical completion if necessary
• Have no contraindications to study procedures, according to provider
• Be willing and able to consent to procedure, either by reading consent document or by having consent document read to her
• Be willing to follow study procedures

You may not qualify if:

• Known previous transmural uterine incision
• Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
• Any contraindications to vaginal delivery, including placenta previa

Sponsors & Collaborators

• Gynuity Health Projects: lead

Study Sites (3)

Bukhara Maternity House No. 1

Bukhara, Uzbekistan

Location

Samarkand Perinatal Center

Samarkand, Uzbekistan

Location

Clinic No. 2, Tashkent Medical Academy

Tashkent, Uzbekistan

Location

Related Publications (1)

• 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:bmjsrh-2018-200167. doi: 10.1136/bmjsrh-2018-200167. Online ahead of print.

  PMID: 31164394 DERIVED

Study Officials

• Dilfuza Kurbanbekova, PhD, MD

  Women's Wellness Center, Uzbekistan

  PRINCIPAL INVESTIGATOR

• Tamar Tsereteli, PhD, MD

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 9, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

UZ (3)