Status:
UNKNOWN
Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Pre-Eclampsia
Gestational Hypertension
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension.
Detailed Description
To evaluate effectiveness of hydrochlorothiazide prophylaxis on prophylaxis, prevention and relapse of preeclampsia or gestational hypertension on readmission rates, need for additional antihypertensi...
Eligibility Criteria
Inclusion
- Maternal age ≥ 18 years and \<50 years.
- 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
- Subject requiring antihypertensive therapy at time of screening.
- 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.
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2024
Estimated Enrollment :
612 Patients enrolled
Trial Details
Trial ID
NCT03298802
Start Date
November 21 2017
End Date
August 30 2024
Last Update
December 5 2023
Active Locations (2)
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1
St. David's North Austin Medical Center
Austin, Texas, United States, 78758
2
University of Texas Medical Branch
Galveston, Texas, United States, 77555