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Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide

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ClinicalTrials.gov Identifier: NCT03298802
Recruitment Status : Recruiting
First Posted : October 2, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Gestational Hypertension Superimposed Pre-Eclampsia Hypertension, Pregnancy-Induced Postpartum Pregnancy-Induced Hypertension Postpartum Preeclampsia Drug: Hydrochlorothiazide 50mg Tablet Drug: Placebo Tablet Phase 3

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  (Clinical Trial)
Estimated Enrollment : 612 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blind randomized placebo controlled clinical trial
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
Primary Purpose: Prevention
Official Title: Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide: a Randomized Clinical Trial
Actual Study Start Date : November 21, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : May 30, 2019


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 Name: 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 Name: sugar pill




Primary Outcome Measures :
  1. Rate of readmission and/or triage visits [ Time Frame: 1-6 weeks postpartum ]
    Any visit in the hospital

  2. Need for additional antihypertensive therapy [ Time Frame: 1-6 weeks postpartum ]
    Requiring additional antihypertensive agents in the postpartum period


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 1-6 weeks postpartum ]
    Days that patient required to be in-house in the postpartum period

  2. Total Additional doses of anti-hypertensive therapy [ Time Frame: 1-6 weeks postpartum ]
    Addition of total doses that patient received in the postpartum period

  3. Elevation of blood pressure >150/90 [ Time Frame: 1-6 weeks postpartum ]
    Hypertension definition in the postpartum period

  4. Severe composite maternal morbidity [ Time Frame: 1-6 weeks postpartum ]
    o Any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy or maternal death

  5. Use of resources [ Time Frame: 1-6 weeks postpartum ]
    hospital stay, postpartum clinic or emergency room visit within 4-6 weeks of delivery, need for imaging or other invasive procedures.

  6. Adverse Events [ Time Frame: 1-6 weeks Postpartum ]
    Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women after delivery of neonate
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298802


Contacts
Contact: Luis A Monsivais, M.D. 9562926223 lamonsiv@utmb.edu
Contact: Violetta Lozovyy, M.D. 2146005015 vilozovy@utmb.edu

Locations
United States, Texas
St. David's North Austin Medical Center Recruiting
Austin, Texas, United States, 78758
Contact: Caroline Gleason, RN    512-821-2540    Caroline.Gleason@hcahealthcare.com   
Luis Monsivais Recruiting
Galveston, Texas, United States, 77555
Contact: Antonio Saad, MD    409-747-6646    afsaad@utmb.edu   
Contact: Luis Monsivais, MD    9562926223    lamonsiv@UTMB.EDU   
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
Principal Investigator: Antonio Saad, M.D. UTMB

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03298802     History of Changes
Other Study ID Numbers: 16-0280
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by The University of Texas Medical Branch, Galveston:
readmission
triage visit for pregnancy related hypertension
hydrochlorothiazide

Additional relevant MeSH terms:
Hypertension
Hypertension, Pregnancy-Induced
Pregnancy Complications
Pre-Eclampsia
Eclampsia
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action