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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WITHDRAWN
PHASE2
INTERVENTIONAL
2016-07-31
2021-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Hydroxychloroquine (HCQ)
Subjects in the experimental arm will take 400 mg hydroxychloroquine pills every day, starting before they get pregnant and continuing until 36 weeks of pregnancy or until the pregnancy is over.
Hydroxychloroquine (HCQ)
Placebo
Subjects in the experimental arm will take placebo pills every day, starting before they get pregnant and continuing until 36 weeks of pregnancy or until the pregnancy is over.
Placebo
Interventions
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Hydroxychloroquine (HCQ)
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planning conception and have experienced 2 or more unexplained pregnancy losses prior to 20 weeks gestation and no more than one live birth
Exclusion Criteria
* Uterine malformation or parental chromosomal abnormality
* Known lupus or other medical conditions that require treatment with hydroxychloroquine outside of this study protocol
* Any medical contraindications to hydroxychloroquine or aspirin therapy, including liver or kidney disease, pregestational diabetes or known retinopathy
18 Years
FEMALE
No
Sponsors
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Intermountain Health Care, Inc.
OTHER
University of Utah
OTHER
Responsible Party
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Robert Silver
M.D.
Principal Investigators
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Robert Silver, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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Intermountain Healthcare
Salt Lake City, Utah, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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78134
Identifier Type: -
Identifier Source: org_study_id
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