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

NCT01150422 | Completed Phase 3 DMC

• 1 other identifier: 6.4
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 4

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. 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. 2.Is an innovative follow-up protocol more acceptable to women and providers than the current standard of care?
3. 3.Is an innovative follow-up protocol feasible to implement in abortion services in Vietnam?

Conditions

Medical Abortion

Keywords

medical abortion

Outcome Measures

Primary Outcomes (1)

• Continued, ongoing pregnancy

  9 months

Secondary Outcomes (2)

• percentage of women who return for follow-up

  9 months

• percentage of women receiving other treatment for ongoing pregnancy

  9 months

Study Arms (2)

Standard of care for post medical abortion follow-up

NO INTERVENTION

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.

Alternative follow-up

ACTIVE COMPARATOR

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

Interventions

Alternative follow-up OTHER

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.

Alternative follow-up

Eligibility Criteria

• Age: 13 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gynuity Health Projects: lead

Study Sites (4)

Hanoi Ob-Gyn Hospital

Hanoi, Vietnam

Location

National Ob-Gyn Hospital

Hanoi, Vietnam

Location

HocMon District Hospital

Ho Chi Minh City, Vietnam

Location

Hung Vuong Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 24463668 DERIVED

Study Officials

• Nguyen Thi Nhu Ngoc, MD, MSc

  Center for Research and Consultancy in Reproductive Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: June 25, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 2, 2011

Record last verified: 2011-04

Locations

VN (4)