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

Phase 3

Completed

• Conditions: Medical Abortion
• Interventions: Other: Alternative follow-up

• 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

Arm && Interventions

Group	Intervention	Description
Alternative follow-up	Alternative follow-up	At their first clinic visit, women will be asked to provide their phone number for contact purposes. Women will also be asked to complete a semi-quantitative pregnancy test in the clinic and the results of the test will be noted on a study form. After mifepristone administration, women will be provided with a second semi-quantitative pregnancy test and a self-administered checklist. Women will be instructed to complete the checklist and perform the pregnancy test at home on an assigned date two weeks after mifepristone administration. The checklist will indicate that if the woman answers "yes" to any of the questions, then she should return to the clinic for a follow-up visit. On the assigned date, women will also be contacted by phone by the clinic staff. Women will be asked to confirm whether they completed the pregnancy test and checklist and asked to report on the results of both tests.

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)

National Ob-Gyn Hospital; 🇻🇳 Hanoi, Vietnam

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

Hanoi Ob-Gyn Hospital; 🇻🇳 Hanoi, Vietnam

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