Mifepristone and Misoprostol for Midtrimester Termination of Pregnancy in Uzbekistan

NCT ID: NCT02235155

Last Updated: 2016-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Abortion in Second Trimester

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dilfuza Kurbanbekova, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Women's Wellness Center, Uzbekistan

Tamar Tsereteli, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Beverly Winikoff, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Locations

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Bukhara Maternity House No. 1

Bukhara, , Uzbekistan

Site Status

Samarkand Perinatal Center

Samarkand, , Uzbekistan

Site Status

Clinic No. 2, Tashkent Medical Academy

Tashkent, , Uzbekistan

Site Status

Countries

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Uzbekistan

References

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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.

Reference Type DERIVED
PMID: 31164394 (View on PubMed)

Other Identifiers

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1017

Identifier Type: -

Identifier Source: org_study_id

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