Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide
- Conditions
- Pre-EclampsiaGestational HypertensionSuperimposed Pre-EclampsiaHypertension, Pregnancy-InducedPostpartum Pregnancy-Induced HypertensionPostpartum Preeclampsia
- Interventions
- Drug: Placebo Tablet
- Registration Number
- NCT03298802
- 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 antihypertensive therapy and number of triage visits.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 612
-
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.)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hydrochlorothiazide 50mg Tablet 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 Tablet Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum
- Primary Outcome Measures
Name Time Method Rate of readmission and/or triage visits 1-6 weeks postpartum Any visit in the hospital
Need for additional antihypertensive therapy 1-6 weeks postpartum Requiring additional antihypertensive agents in the postpartum period
- Secondary Outcome Measures
Name Time Method Length of hospital stay 1-6 weeks postpartum Days that patient required to be in-house in the postpartum period
Adverse Events 1-6 weeks Postpartum Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)
Total Additional doses of anti-hypertensive therapy 1-6 weeks postpartum Addition of total doses that patient received in the postpartum period
Severe composite maternal morbidity 1-6 weeks postpartum o Any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy or maternal death
Elevation of blood pressure >150/90 1-6 weeks postpartum Hypertension definition in the postpartum period
Use of resources 1-6 weeks postpartum hospital stay, postpartum clinic or emergency room visit within 4-6 weeks of delivery, need for imaging or other invasive procedures.
Trial Locations
- Locations (2)
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
St. David's North Austin Medical Center
🇺🇸Austin, Texas, United States