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
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:
- 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?
- Is an innovative follow-up protocol more acceptable to women and providers than the current standard of care?
- 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|
|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|
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.
- Continued, ongoing pregnancy [ Time Frame: 9 months ]
- 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 ]
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
|Hanoi Ob-Gyn Hospital|
|National Ob-Gyn Hospital|
|HocMon District Hospital|
|Ho Chi Minh City, Vietnam|
|Hung Vuong Hospital|
|Ho Chi Minh City, Vietnam|
|Principal Investigator:||Nguyen Thi Nhu Ngoc, MD, MSc||Center for Research and Consultancy in Reproductive Health|