- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01150422
The Acceptability and Feasibility of an Alternative to Routine Follow-up Visit After Medical Abortion in Vietnam
The Acceptability and Feasibility of an Alternative to a 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:
- 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?
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Hanoi, Vietnam
- National Ob-Gyn Hospital
-
Hanoi, Vietnam
- Hanoi Ob-Gyn Hospital
-
Ho Chi Minh City, Vietnam
- HocMon District Hospital
-
Ho Chi Minh City, Vietnam
- Hung Vuong Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Continued, ongoing pregnancy
Time Frame: 9 months
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
percentage of women who return for follow-up
Time Frame: 9 months
|
9 months
|
percentage of women receiving other treatment for ongoing pregnancy
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nguyen Thi Nhu Ngoc, MD, MSc, Center for Research and Consultancy in Reproductive Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 6.4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Medical Abortion
-
Gynuity Health ProjectsCompletedMedical AbortionArmenia, Georgia, Kazakhstan
-
Gynuity Health ProjectsCompletedMedical AbortionUnited States, Vietnam, Georgia, Azerbaijan, Mexico
-
Gynuity Health ProjectsStanford University; Secretaría de Salud del Distrito Federal; Office National... and other collaboratorsCompletedMedical AbortionUnited States, Mexico, Tunisia, Vietnam
-
Karolinska InstitutetUllevaal University Hospital; University of Helsinki; Gynmed Clinic ViennaCompletedMedical AbortionSweden, Austria, Finland, Norway
-
World Health OrganizationCenter for Research and Environmental Health and Population Activities (CREHPA)Completed
-
Gynuity Health ProjectsPlanned Parenthood Federation of America; David and Lucile Packard FoundationCompleted
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedMedical; Abortion, Fetus | Second Trimester AbortionTurkey
-
Stanford UniversityCompleted
-
Gynuity Health ProjectsCompleted
-
Gynuity Health ProjectsFamily Planning Association PakistanCompleted
Clinical Trials on Alternative follow-up
-
Gynuity Health ProjectsBritish Pregnancy Advisory Service (UK) (bpas)CompletedLegally Induced Abortion, Complete, Without Mention of ComplicationUnited Kingdom
-
Istanbul University - Cerrahpasa (IUC)CompletedInfertility | Psychological Distress | Infertility, Female | Depression, Anxiety | Nurse's RoleTurkey
-
M.D. Anderson Cancer CenterRecruitingRecurrent Mantle Cell Lymphoma | Refractory Mantle Cell LymphomaUnited States
-
Connolly Hospital BlanchardstownCompletedGeneral Surgery | Outpatients | Virtual Clinic | Text MessagingIreland
-
Sport Injury Prevention Research CentreGeneral Electric; National Basketball AssociationCompletedTendinopathy | Sports Injuries in Children | Injury, Knee | Injury, AnkleCanada
-
Gynuity Health ProjectsCompletedMedical Abortion, FetusMoldova, Republic of, Uzbekistan
-
Centre Hospitalier Universitaire, AmiensRecruitingQuality of Life | Pain | Lumbar Spine SurgeryFrance
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development; Trialbureau... and other collaboratorsRecruitingAdolescent Idiopathic ScoliosisNetherlands
-
Rennes University HospitalUnknown
-
University of IcelandMemorial Sloan Kettering Cancer Center; Landspitali University Hospital; deCODE... and other collaboratorsActive, not recruitingMonoclonal Gammopathy of Undetermined SignificanceIceland