Purpose

Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension.

Conditions

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

ArmDescriptionAssigned 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.
  • Drug: 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.
    Other names:
    • HydroDIURIL, Microzide, Esidrix, Oretic
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
  • Drug: Placebo Tablet
    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
    Other names:
    • sugar pill

Recruiting Locations

Luis Monsivais
Galveston, Texas 77555
Contact:
Antonio Saad, MD
409-747-6646
afsaad@utmb.edu

More Details

NCT ID
NCT03298802
Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Luis A Monsivais, M.D.
9562926223
lamonsiv@utmb.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.