NCT01410266

Brief Summary

The purpose of this study is to determine whether an alternative method of follow-up after medical abortion is acceptable and feasible for use in Moldova and Uzbekistan.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2010

Typical duration for phase_4

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

Enrollment Period

2.1 years

First QC Date

August 3, 2011

Last Update Submit

November 30, 2012

Conditions

Medical Abortion, Fetus

Keywords

medical abortionfirst trimesterfollow-uppregnancy test

Outcome Measures

Primary Outcomes (1)

  • Continued, ongoing pregnancy

    1 month

Secondary Outcomes (2)

  • Percentage of women who return for follow-up

    1 month

  • Percentage of women receiving other treatment for ongoing pregnancy

    1 month

Study Arms (2)

Standard of care

NO INTERVENTION

Standard of care includes a routine clinic visit two weeks after misoprostol administration. At the clinic visit, the woman undergoes a bimanual examination. In the event the woman fails to return for the follow-up visit, clinic procedure is followed for contacting her to determine abortion status and the need for further intervention, if any.

Alternative follow-up

ACTIVE COMPARATOR

At a clinic visit, before mifepristone administration, the woman completes a semi-quantitative pregnancy test. After mifepristone administration, she is provided with another pregnancy test and a checklist to be self-administered two weeks after she takes misoprostol. On an assigned date, the woman is contacted by phone by the clinic staff and asked to report on the results of both tests. The provider then confirms whether, based on the woman's responses, she should return for a follow-up visit.

Other: Alternative follow-up

Interventions

Alternative follow-upOTHER

Alternative follow-up consists of a self-administered semi-quantitative pregnancy test designed to measure urine beta-hCG levels, and a self-administered questionnaire consisting of 7 questions. Results of both are reviewed by the provider to determine if in-clinic follow-up is needed.

Also known as: semi-quantitative pregnancy test, self-administered questionnaire
Alternative follow-up

Eligibility Criteria

Age16 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Reproductive-age woman seeking a medical abortion
  • Woman in good general health
  • Woman with an intrauterine pregnancy less than or equal to 63 days gestation on the day of mifepristone administration
  • Woman able and willing to sign consent forms
  • Woman eligible for medical abortion according to clinician's assessment
  • Woman agreeing to be followed up with, by phone or at a clinic visit

You may not qualify if:

  • Woman with a pregnancy greater than 63 days gestation on the day of mifepristone administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

The Perinatalogy Center

Bălţi, Moldova

Location

Municipal Clinical Hospital

Chisinau, Moldova

Location

The National Center of Reproductive Health and Medical Genetics

Chisinau, Moldova

Location

The Center of Women Health "Ana"

Drochia, Moldova

Location

Clinic #2 of Tashkent Medical Academy

Tashkent, Uzbekistan

Location

Municipal Maternity House #10

Tashkent, Uzbekistan

Location

Women's Wellness Center

Tashkent, Uzbekistan

Location

Related Publications (1)

  • Platais I, Tsereteli T, Comendant R, Kurbanbekova D, Winikoff B. Acceptability and feasibility of phone follow-up with a semiquantitative urine pregnancy test after medical abortion in Moldova and Uzbekistan. Contraception. 2015 Feb;91(2):178-83. doi: 10.1016/j.contraception.2014.11.004. Epub 2014 Nov 15.

    PMID: 25497383DERIVED

Study Officials

  • Hillary J. Bracken, PhD, MHS, MA

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2011

First Posted

August 5, 2011

Study Start

September 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 3, 2012

Record last verified: 2012-11

Locations

MO(4)UZ(3)