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

Medical Abortion, Fetus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410266
• Other study ID #: 6.5
• Status: Completed
• Phase: Phase 4
• First received: August 3, 2011
• Last updated: November 30, 2012
• Start date: September 2010
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Moldova: Ministry of HealthUzbekistan: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2400
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Medical Abortion, Fetus

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

Moldova, Republic of,  Uzbekistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continued, ongoing pregnancy		1 month	No
Secondary	Percentage of women who return for follow-up		1 month	No
Secondary	Percentage of women receiving other treatment for ongoing pregnancy		1 month	No