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

Gynuity Health Projects1,500 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

1,500

Conditions

Medical Abortion

Interventions

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.

Eligibility

Sex: FEMALEMin age: 13 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Continued, ongoing pregnancy

Time frame: 9 months

Secondary Outcomes

percentage of women who return for follow-up

Time frame: 9 months

percentage of women receiving other treatment for ongoing pregnancy

Time frame: 9 months