Reducing the Need for In-Clinic Follow-Up for Medical Abortion in Moldova and Uzbekistan

The Acceptability and Feasibility of Reducing the Need for In-Clinic Follow-Up for First Trimester Medical Abortion in Moldova and Uzbekistan

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.

Study Overview

• Status: Completed
• Conditions: Medical Abortion, Fetus
• Intervention / Treatment: Other: Alternative follow-up

Detailed Description

Medical abortion using mifepristone and misoprostol is a highly effective procedure, but access to it may be impeded by the fact that not all women can afford or want to return for a follow-up visit. This often results in a high loss to follow-up rate. Additionally, with medical abortions of those women who do return for follow-up, higher costs are borne by both the woman and the healthcare system.

This study compares two methods of follow-up after medical abortion: standard of care versus alternative follow-up. The former involves a routine clinic visit two weeks after misoprostol administration. The latter consists of a low-sensitivity pregnancy test and a self-administered questionnaire. Based on the results of the test and questionnaire, women may be flagged as needing in-clinic follow-up or discharged from the study if their abortion is complete.

• Study Type: Interventional
• Enrollment (Actual): 2400
• Phase: Phase 4

Contacts and Locations

Study Locations

• Moldova, Republic of
  • Balti, Moldova, Republic of
    • The Perinatalogy Center
  • Chisinau, Moldova, Republic of
    • Municipal Clinical Hospital
  • Chisinau, Moldova, Republic of
    • The National Center of Reproductive Health and Medical Genetics
  • Drochia, Moldova, Republic of
    • The Center of Women Health "Ana"
• Uzbekistan
  • Tashkent, Uzbekistan
    • Clinic #2 of Tashkent Medical Academy
  • Tashkent, Uzbekistan
    • Municipal Maternity House #10
  • Tashkent, Uzbekistan
    • Women's Wellness Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 55 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Standard of care; 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.
ACTIVE_COMPARATOR: Alternative follow-up; 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; 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.; Other Names: semi-quantitative pregnancy test; self-administered questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Continued, ongoing pregnancy	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of women who return for follow-up	1 month
Percentage of women receiving other treatment for ongoing pregnancy	1 month

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Investigators: Principal Investigator: Hillary J. Bracken, PhD, MHS, MA, Gynuity Health Projects

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: August 3, 2011
• First Submitted That Met QC Criteria: August 3, 2011
• First Posted (ESTIMATE): August 5, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 3, 2012
• Last Update Submitted That Met QC Criteria: November 30, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: follow-up; medical abortion; first trimester; pregnancy test
• Other Study ID Numbers: 6.5