Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide
Purpose
Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension.
Conditions
- Pre-Eclampsia
- Gestational Hypertension
- Superimposed Pre-Eclampsia
- Hypertension, Pregnancy-Induced
- Postpartum Pregnancy-Induced Hypertension
- Postpartum Preeclampsia
Eligibility
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- double-blind randomized placebo controlled clinical trial
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- Randomization will be performed by a person not involved in the clinical trial using a computer random list of numbers generated using STATA (StataCorp 14.0, Dallas, TX). This list of random number assignments will be kept secure and sent directly to the investigational drug service (IDS), who will be responsible for the allocation and dispensing of the medications
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator 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 Comparator Placebo Tablet |
Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum |
|
Recruiting Locations
University of Texas Medical Branch
Galveston, Texas 77555
Galveston, Texas 77555
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Medical Branch, Galveston
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.