Clinical trial NCT03298802: Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide
Official title: Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pre-Eclampsia
Gestational Hypertension
Superimposed Pre-Eclampsia
Hypertension, Pregnancy-Induced
Postpartum Pregnancy-Induced Hypertension
Postpartum Preeclampsia
Keywords: readmission
triage visit for pregnancy related hypertension
hydrochlorothiazide
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 612
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind randomized placebo controlled clinical trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of readmission and/or triage visits
timeFrame: 1-6 weeks postpartum
measure: Need for additional antihypertensive therapy
timeFrame: 1-6 weeks postpartum
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 1-6 weeks postpartum
measure: Total Additional doses of anti-hypertensive therapy
timeFrame: 1-6 weeks postpartum
measure: Elevation of blood pressure >150/90
timeFrame: 1-6 weeks postpartum
measure: Severe composite maternal morbidity
timeFrame: 1-6 weeks postpartum
measure: Use of resources
timeFrame: 1-6 weeks postpartum
measure: Adverse Events
timeFrame: 1-6 weeks Postpartum
Other outcomes:
Locations:
city: Austin
country: United States
facility: St. David's North Austin Medical Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: UTMB
name: Benjamin Bush, M.D.
role: PRINCIPAL_INVESTIGATOR
References: