Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide

NCT03298802 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: 16-0280
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 2

Brief Summary

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

Keywords

readmission; triage visit for pregnancy related hypertension; hydrochlorothiazide

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Length of hospital stay

  1-6 weeks postpartum

• Total Additional doses of anti-hypertensive therapy

  1-6 weeks postpartum

• Elevation of blood pressure >150/90

  1-6 weeks postpartum

• Severe composite maternal morbidity

  1-6 weeks postpartum

• Use of resources

  1-6 weeks postpartum

Study Arms (2)

Hydrochlorothiazide 50mg Tablet

ACTIVE COMPARATOR

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

Placebo Tablet

PLACEBO COMPARATOR

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

Interventions

Hydrochlorothiazide 50mg Tablet DRUG

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.

Also known as: HydroDIURIL, Microzide, Esidrix, Oretic

Hydrochlorothiazide 50mg Tablet

Placebo Tablet DRUG

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

Also known as: sugar pill

Placebo Tablet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Women after delivery of neonate
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (2)

St. David's North Austin Medical Center

Austin, Texas, 78758, United States

RECRUITING

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced

Interventions

Hydrochlorothiazide; Tablets; Sugars

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Carbohydrates

Study Officials

• Benjamin Bush, M.D.

  UTMB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan C Shepherd, M.D.

CONTACT

409-772-0312; mcshephe@UTMB.EDU

Ashley Salazar, RN

CONTACT

409-772-0312; assalaza@utmb.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double-blind randomized placebo controlled clinical trial

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: October 2, 2017
• Study Start: November 21, 2017
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)