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
612
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
RECRUITINGUniversity of Texas Medical Branch
Galveston, Texas, United States
RECRUITINGRate of readmission and/or triage visits
Any visit in the hospital
Time frame: 1-6 weeks postpartum
Need for additional antihypertensive therapy
Requiring additional antihypertensive agents in the postpartum period
Time frame: 1-6 weeks postpartum
Length of hospital stay
Days that patient required to be in-house in the postpartum period
Time frame: 1-6 weeks postpartum
Total Additional doses of anti-hypertensive therapy
Addition of total doses that patient received in the postpartum period
Time frame: 1-6 weeks postpartum
Elevation of blood pressure >150/90
Hypertension definition in the postpartum period
Time frame: 1-6 weeks postpartum
Severe composite maternal morbidity
o Any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy or maternal death
Time frame: 1-6 weeks postpartum
Use of resources
hospital stay, postpartum clinic or emergency room visit within 4-6 weeks of delivery, need for imaging or other invasive procedures.
Time frame: 1-6 weeks postpartum
Adverse Events
Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)
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Time frame: 1-6 weeks Postpartum