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

Medical Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150422
• Other study ID #: 6.4
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2010
• Last updated: April 29, 2011
• Start date: April 2010
• Est. completion date: April 2011

Study information

• Verified date: April 2011
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Scientific Committee, Hung Vuong HospitalVietnam: Scientific Committee, Health Committee of HCMC
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 55 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Medical Abortion

Intervention

Other:
• Alternative follow-up
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 data two weeks after mifepristone administration. 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. Provider will review the women's responses to the checklist and confirm whether, based on the woman's responses, she should return for a follow up visit. During the follow-up phone call, women will also be asked about the satisfaction and acceptability of the alternative follow-up procedure.

Locations

Country	Name	City	State
Vietnam	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

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continued, ongoing pregnancy		9 months	No
Secondary	percentage of women who return for follow-up		9 months	No
Secondary	percentage of women receiving other treatment for ongoing pregnancy		9 months	No