Effectiveness of Pregnancy Tests as an Assessment Tool to Identify Continuing Pregnancy
NCT ID: NCT01856777
Last Updated: 2014-05-14
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
NA
600 participants
INTERVENTIONAL
2013-06-30
2014-02-28
Brief Summary
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1. The investigators hypothesize that 99% of the SQPT and 35% of the HSPT will correctly identify ongoing pregnancy at day 14.
2. The investigators hypothesize that 99% of the SQPT and 25% of the HSPT will correctly identify ongoing pregnancy at day 7.
3. The investigators hypothesize that 75% of the SQPT and 10% of the HSPT will correctly identify ongoing pregnancy at day 4.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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High sensitivity urine pregnancy test
Standard medical care and high sensitivity urine pregnancy test
High sensitivity urine pregnancy test
Semi-quantitative panel test
Standard medical care and semi-quantitative panel test
Semi-quantitative panel test
Interventions
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Semi-quantitative panel test
High sensitivity urine pregnancy test
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eligible for mifepristone- misoprostol medical abortion according to clinic guidelines(national guidelines stipulate that women can receive medical abortion thru 63 days LMP at Hung Vuong (tertiary level) hospital; women with gestations up to 49 days LMP can receive medical abortion at Hocmon (district) hospital)
* Willing to follow instructions of the provider regarding use of the pregnancy tests
* Able to read and write to use pregnancy test at home
* Willing to be randomized to perform one of two types of urine pregnancy tests at three time points at home
* Willing to provide an address and/or telephone number for purposes of follow-up
* Agrees to return for follow-up visit at clinic to confirm abortion status
* Wishes to participate in the study
* Able to consent to study participation
FEMALE
Yes
Sponsors
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Gynuity Health Projects
OTHER
Responsible Party
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Principal Investigators
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Beverly Winikoff, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Nguyen Thi Nhu Ngoc, MD, MsC
Role: PRINCIPAL_INVESTIGATOR
CRCRH
Paul Blumenthal, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Wendy Sheldon, MPH, MSW, PhD
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Locations
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Hocmon General District Hospital
Hochiminh City, , Vietnam
Hungvuong Hospital
Hochiminh City, , Vietnam
Countries
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Other Identifiers
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6003
Identifier Type: -
Identifier Source: org_study_id
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