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

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

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?

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Phase 3

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • National Ob-Gyn Hospital
  • Hanoi, Vietnam
    • Hanoi Ob-Gyn Hospital
  • Ho Chi Minh City, Vietnam
    • HocMon District Hospital
  • Ho Chi Minh City, Vietnam
    • Hung Vuong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care for post medical abortion follow-up; Standard of care includes a routine hospital visit two weeks after mifepristone administration. At the hospital visit, the woman will undergo a bimanual and vaginal ultrasound examination. In the event the woman fails to return for the follow-up visit, each hospital will follow their standard procedure for contacting women who fail to attend their follow-up visit, i.e. three efforts to contact the woman. Form 2a will document the results of any clinical examinations, any additional medical abortion-related care given and the abortion outcome. At the follow-up visit, women will also be asked about the acceptability of current medical abortion follow-up procedures and their future preferences.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Continued, ongoing pregnancy	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
percentage of women who return for follow-up	9 months
percentage of women receiving other treatment for ongoing pregnancy	9 months

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Investigators: Principal Investigator: Nguyen Thi Nhu Ngoc, MD, MSc, Center for Research and Consultancy in Reproductive Health

Publications and helpful links

General Publications

• Ngoc NTN, Bracken H, Blum J, Nga NTB, Minh NH, van Nhang N, Lynd K, Winikoff B, Blumenthal PD. Acceptability and feasibility of phone follow-up after early medical abortion in Vietnam: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):88-95. doi: 10.1097/AOG.0000000000000050.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: May 7, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (Estimate): June 25, 2010

Study Record Updates

• Last Update Posted (Estimate): May 2, 2011
• Last Update Submitted That Met QC Criteria: April 29, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: medical abortion
• Other Study ID Numbers: 6.4