The Acceptability and Feasibility of an Alternative to Routine Follow-up Visit After Medical Abortion in Vietnam

Phase 3

Completed

• Conditions: Medical Abortion

• Registration Number: NCT01150422
• Lead Sponsor: Gynuity Health Projects

Brief Summary

This trial will compare the efficacy and acceptability of post-medical abortion follow-up by assigning women to either 1) alternative follow-up via routine semi-quantitative pregnancy test and a self-administered follow-up questionnaire, or 2) the standard of care: a routine follow-up visit including a bimanual exam and vaginal ultrasound.

The goal of the study is to provide answers to the following questions:

1. Is a follow-up protocol that employs a self-administered questionnaire and at home use of a semi-quantitative pregnancy test effective at identifying women with ongoing pregnancies?

2. Is an innovative follow-up protocol more acceptable to women and providers than the current standard of care?

3. Is an innovative follow-up protocol feasible to implement in abortion services in Vietnam?

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-07
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Status Verified: 2011-04
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Last Update Submitted: 2011-04-29
• Last Update Posted: 2011-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1500

Inclusion Criteria

• Reproductive age women seeking medical abortion services
• Intrauterine pregnancy less than or equal to 63 days gestation on the day of mifepristone administration
• Hold a working, personal phone number
• be willing and able to sign consent forms and agree to comply with study procedures

Exclusion Criteria

• Pregnancy greater than 63 days gestation on the day of mifepristone administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Continued, ongoing pregnancy	9 months

Secondary Outcome Measures

Name	Time	Method
percentage of women who return for follow-up	9 months
percentage of women receiving other treatment for ongoing pregnancy	9 months

Trial Locations

Locations (4)

Hanoi Ob-Gyn Hospital; 🇻🇳 Hanoi, Vietnam

National Ob-Gyn Hospital; 🇻🇳 Hanoi, Vietnam

HocMon District Hospital; 🇻🇳 Ho Chi Minh City, Vietnam

Hung Vuong Hospital; 🇻🇳 Ho Chi Minh City, Vietnam