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Completed

NCT Number: NCT01150422

The Acceptability and Feasibility of an Alternative to 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?

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Key information

Conditions

Medical Abortion

Age range

13 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hanoi Ob-Gyn Hospital, Hanoi, Vietnam

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Continued, ongoing pregnancy

    Time frame: 9 months

Secondary outcomes

  1. percentage of women who return for follow-up

    Time frame: 9 months

  2. percentage of women receiving other treatment for ongoing pregnancy

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 25, 2010
Registry last updated
May 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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