Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension.
To evaluate effectiveness of hydrochlorothiazide prophylaxis on prophylaxis, prevention and relapse of preeclampsia or gestational hypertension on readmission rates, need for additional antihypertensive therapy and number of triage visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
453
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 per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum
St. David's North Austin Medical Center
Austin, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Number of Participants Required Re-Admission or Triage Visit
Any participants who had a visit to the hospital during the 1-6 weeks postpartum.
Time frame: 1-6 weeks postpartum
Number of Participants That Need Additional Antihypertensive Therapy
Number of participants requiring additional antihypertensive agents in 1-6 weeks postpartum window
Time frame: 1-6 weeks postpartum
Length of Hospital Stay
Days that participants required to be in-house in the postpartum period
Time frame: 1-6 weeks postpartum
Total Additional Doses of Anti-hypertensive Therapy
Number of participants that receive one additional doses in the 1-6 weeks postpartum
Time frame: 1-6 weeks postpartum
Elevation of Blood Pressure >150/90
Number of participants that have a blood pressure greater than 150/90 in the 1-6 weeks postpartum window
Time frame: 1-6 weeks postpartum
Severe Composite Maternal Morbidity
Number of participants with any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy or maternal death.
Time frame: 1-6 weeks postpartum
Adverse Events
Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)
Time frame: 1-6 weeks Postpartum
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