Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide
NCT ID: NCT03298802
Last Updated: 2023-12-05
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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RECRUITING
PHASE3
612 participants
INTERVENTIONAL
2017-11-21
2024-08-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Hydrochlorothiazide 50mg Tablet
Hydrochlorothiazide 50 mg per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum.
Hydrochlorothiazide 50mg Tablet
Hydrochlorothiazide 50 mg per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum.
Placebo Tablet
Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum
Placebo Tablet
Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum
Interventions
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Hydrochlorothiazide 50mg Tablet
Hydrochlorothiazide 50 mg per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum.
Placebo Tablet
Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of gestational hypertension\* or preeclampsia\^ at any time during pregnancy, labor or postpartum.
* defined as isolated systolic BP of 140 mm Hg or greater, a diastolic BP of 90 mm Hg or greater, or both) or \^ defines as new-onset hypertension plus new-onset proteinuria, or in the absence of proteinuria, preeclampsia is diagnosed as hypertension in association with thrombocytopenia (platelet count less than 100,000/microliter), impaired liver function (elevated blood levels of liver transaminases to twice the normal concentration), the new development of renal insufficiency (elevated serum creatinine greater than 1.1 mg/dL or a doubling of serum creatinine in the absence of other renal disease), pulmonary edema, or new-onset cerebral or visual disturbances.)
Exclusion Criteria
* Planned discharge with oral anti-hypertensive medication.
* Contraindication to hydrochlorothiazide (advanced renal failure or anuria, hypersensitivity to sulfonamides).
* Subject not able to follow up postpartum.
* Lactose intolerance.
* Pre-gestational diabetes.
18 Years
50 Years
FEMALE
No
Sponsors
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The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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Benjamin Bush, M.D.
Role: PRINCIPAL_INVESTIGATOR
UTMB
Locations
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St. David's North Austin Medical Center
Austin, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Caroline Gleason, RN
Role: primary
Benjamin Bush, MD
Role: primary
Other Identifiers
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16-0280
Identifier Type: -
Identifier Source: org_study_id