Clinical trial NCT02235155: Mifepristone and Misoprostol for Midtrimester Termination of Pregnancy in Uzbekistan
Official title: Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Uzbekistan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abortion in Second Trimester
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 135
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of abortions that are complete as a measure of efficacy
timeFrame: At 15 hours after the start of misoprostol administration
Secondary outcomes:
measure: Interval of time between induction with misoprostol to complete abortion
timeFrame: Every 3 hours from the start of misoprostol administration until complete abortion
measure: Women's satisfaction with the method
timeFrame: At discharge, up to 5 days after enrollment
measure: Side effects experienced by women
timeFrame: Every 3 hours from the start of misoprostol administration until complete abortion
measure: Pain experienced by women
timeFrame: At the time of discharge, up to 5 days after enrollment
measure: Complications during induction and after discharge
timeFrame: Every 3 hours from the start of misoprostol administration, up to 1 month after discharge
measure: Women's perception of acceptability of the procedure
timeFrame: At discharge, up to 5 days after enrollment
measure: Provider's perception of acceptability of the method
timeFrame: At study completion, up to 2 years after study enrollment commences
measure: Total dose of misoprostol administered
timeFrame: Every 3 hours from start of misoprostol administration to complete abortion
Other outcomes:
Locations:
city: Bukhara
country: Uzbekistan
facility: Bukhara Maternity House No. 1
city: Samarkand
country: Uzbekistan
facility: Samarkand Perinatal Center
city: Tashkent
country: Uzbekistan
facility: Clinic No. 2, Tashkent Medical Academy
Study officials:
affiliation: Women's Wellness Center, Uzbekistan
name: Dilfuza Kurbanbekova, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Tamar Tsereteli, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.