Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide

Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide: a Randomized Clinical Trial

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

Study Overview

• Status: Recruiting
• Conditions: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Postpartum Preeclampsia; Gestational Hypertension; Superimposed Pre-Eclampsia; Postpartum Pregnancy-Induced Hypertension
• Intervention / Treatment: Drug: Hydrochlorothiazide 50mg Tablet; Drug: Placebo Tablet

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.

• Study Type: Interventional
• Enrollment (Estimated): 612
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Megan C Shepherd, M.D.; Phone Number: 409-772-0312; Email: mcshephe@UTMB.EDU
• Study Contact Backup: Name: Ashley Salazar, RN; Phone Number: 409-772-0312; Email: assalaza@utmb.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78758
      • Recruiting
      • St. David's North Austin Medical Center
      • Contact: Caroline Gleason, RN; Phone Number: 512-821-2540; Email: Caroline.Gleason@hcahealthcare.com
    • Galveston, Texas, United States, 77555
      • Recruiting
      • University of Texas Medical Branch
      • Contact: Benjamin Bush, MD; Phone Number: 409-772-1011; Email: babush@utmb.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of readmission and/or triage visits	Any visit in the hospital	1-6 weeks postpartum
Need for additional antihypertensive therapy	Requiring additional antihypertensive agents in the postpartum period	1-6 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Days that patient required to be in-house in the postpartum period	1-6 weeks postpartum
Total Additional doses of anti-hypertensive therapy	Addition of total doses that patient received in the postpartum period	1-6 weeks postpartum
Elevation of blood pressure >150/90	Hypertension definition in the postpartum period	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	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.	1-6 weeks postpartum
Adverse Events	Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)	1-6 weeks Postpartum

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Benjamin Bush, M.D., UTMB

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2017
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (Actual): October 2, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: readmission; hydrochlorothiazide; triage visit for pregnancy related hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Eclampsia; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Chloride Symporter Inhibitors; Hydrochlorothiazide
• Other Study ID Numbers: 16-0280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes