Reducing the Need for In-Clinic Follow-Up for Medical Abortion in Moldova and Uzbekistan
NCT ID: NCT01410266
Last Updated: 2012-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
2400 participants
INTERVENTIONAL
2010-09-30
2012-10-31
Brief Summary
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Detailed Description
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This study compares two methods of follow-up after medical abortion: standard of care versus alternative follow-up. The former involves a routine clinic visit two weeks after misoprostol administration. The latter consists of a low-sensitivity pregnancy test and a self-administered questionnaire. Based on the results of the test and questionnaire, women may be flagged as needing in-clinic follow-up or discharged from the study if their abortion is complete.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Standard of care
Standard of care includes a routine clinic visit two weeks after misoprostol administration. At the clinic visit, the woman undergoes a bimanual examination. In the event the woman fails to return for the follow-up visit, clinic procedure is followed for contacting her to determine abortion status and the need for further intervention, if any.
No interventions assigned to this group
Alternative follow-up
At a clinic visit, before mifepristone administration, the woman completes a semi-quantitative pregnancy test. After mifepristone administration, she is provided with another pregnancy test and a checklist to be self-administered two weeks after she takes misoprostol. On an assigned date, the woman is contacted by phone by the clinic staff and asked to report on the results of both tests. The provider then confirms whether, based on the woman's responses, she should return for a follow-up visit.
Alternative follow-up
Alternative follow-up consists of a self-administered semi-quantitative pregnancy test designed to measure urine beta-hCG levels, and a self-administered questionnaire consisting of 7 questions. Results of both are reviewed by the provider to determine if in-clinic follow-up is needed.
Interventions
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Alternative follow-up
Alternative follow-up consists of a self-administered semi-quantitative pregnancy test designed to measure urine beta-hCG levels, and a self-administered questionnaire consisting of 7 questions. Results of both are reviewed by the provider to determine if in-clinic follow-up is needed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Woman in good general health
* Woman with an intrauterine pregnancy less than or equal to 63 days gestation on the day of mifepristone administration
* Woman able and willing to sign consent forms
* Woman eligible for medical abortion according to clinician's assessment
* Woman agreeing to be followed up with, by phone or at a clinic visit
Exclusion Criteria
16 Years
55 Years
FEMALE
Yes
Sponsors
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Gynuity Health Projects
OTHER
Responsible Party
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Principal Investigators
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Hillary J. Bracken, PhD, MHS, MA
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Beverly Winikoff, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Locations
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The Perinatalogy Center
Bălţi, , Moldova
Municipal Clinical Hospital
Chisinau, , Moldova
The National Center of Reproductive Health and Medical Genetics
Chisinau, , Moldova
The Center of Women Health "Ana"
Drochia, , Moldova
Clinic #2 of Tashkent Medical Academy
Tashkent, , Uzbekistan
Municipal Maternity House #10
Tashkent, , Uzbekistan
Women's Wellness Center
Tashkent, , Uzbekistan
Countries
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References
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Platais I, Tsereteli T, Comendant R, Kurbanbekova D, Winikoff B. Acceptability and feasibility of phone follow-up with a semiquantitative urine pregnancy test after medical abortion in Moldova and Uzbekistan. Contraception. 2015 Feb;91(2):178-83. doi: 10.1016/j.contraception.2014.11.004. Epub 2014 Nov 15.
Other Identifiers
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6.5
Identifier Type: -
Identifier Source: org_study_id