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

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ClinicalTrials.gov Identifier: NCT01150422
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : May 2, 2011
Sponsor:
Information provided by:
Gynuity Health Projects

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. 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?

Condition or disease Intervention/treatment Phase
Medical Abortion Other: Alternative follow-up Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Acceptability and Feasibility of an Alternative to a Routine Follow-up Visit After Medical Abortion in Vietnam
Study Start Date : April 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

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.




Primary Outcome Measures :
  1. Continued, ongoing pregnancy [ Time Frame: 9 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150422


Locations
Vietnam
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
Sponsors and Collaborators
Gynuity Health Projects
Investigators
Principal Investigator: Nguyen Thi Nhu Ngoc, MD, MSc Center for Research and Consultancy in Reproductive Health, Ho Chi Minh City, Vietnam

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hillary Bracken, Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01150422     History of Changes
Other Study ID Numbers: 6.4
First Posted: June 25, 2010    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: April 2011

Keywords provided by Gynuity Health Projects:
medical abortion

Additional relevant MeSH terms:
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents