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

Gynuity Health Projects

Status and phase: Completed; Phase 3

Conditions: Medical Abortion

Treatments: Other: Alternative follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT01150422

6.4

Details and patient eligibility

About

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?

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 13 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Standard of care for post medical abortion follow-up

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Alternative follow-up