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Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide

Primary Purpose

Pre-Eclampsia, Gestational Hypertension, Superimposed Pre-Eclampsia

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hydrochlorothiazide 50mg Tablet
Placebo Tablet
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-Eclampsia focused on measuring readmission, triage visit for pregnancy related hypertension, hydrochlorothiazide

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • St. David's North Austin Medical CenterRecruiting
  • University of Texas Medical BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hydrochlorothiazide 50mg Tablet

Placebo Tablet

Arm Description

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.

Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum

Outcomes

Primary Outcome Measures

Rate of readmission and/or triage visits
Any visit in the hospital
Need for additional antihypertensive therapy
Requiring additional antihypertensive agents in the postpartum period

Secondary Outcome Measures

Length of hospital stay
Days that patient required to be in-house in the postpartum period
Total Additional doses of anti-hypertensive therapy
Addition of total doses that patient received in the postpartum period
Elevation of blood pressure >150/90
Hypertension definition in the postpartum period
Severe composite maternal morbidity
o Any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy or maternal death
Use of resources
hospital stay, postpartum clinic or emergency room visit within 4-6 weeks of delivery, need for imaging or other invasive procedures.
Adverse Events
Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)

Full Information

First Posted
September 20, 2017
Last Updated
August 18, 2022
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT03298802
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
double-blind randomized placebo controlled clinical trial
Masking
ParticipantCare ProviderInvestigator
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
Allocation
Randomized
Enrollment
612 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydrochlorothiazide 50mg Tablet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Tablet
Arm Type
Placebo Comparator
Arm Description
Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for fourteen days postpartum
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide 50mg Tablet
Other Intervention Name(s)
HydroDIURIL, Microzide, Esidrix, Oretic
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo Tablet
Other Intervention Name(s)
sugar pill
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of readmission and/or triage visits
Description
Any visit in the hospital
Time Frame
1-6 weeks postpartum
Title
Need for additional antihypertensive therapy
Description
Requiring additional antihypertensive agents in the postpartum period
Time Frame
1-6 weeks postpartum
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Days that patient required to be in-house in the postpartum period
Time Frame
1-6 weeks postpartum
Title
Total Additional doses of anti-hypertensive therapy
Description
Addition of total doses that patient received in the postpartum period
Time Frame
1-6 weeks postpartum
Title
Elevation of blood pressure >150/90
Description
Hypertension definition in the postpartum period
Time Frame
1-6 weeks postpartum
Title
Severe composite maternal morbidity
Description
o Any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy or maternal death
Time Frame
1-6 weeks postpartum
Title
Use of resources
Description
hospital stay, postpartum clinic or emergency room visit within 4-6 weeks of delivery, need for imaging or other invasive procedures.
Time Frame
1-6 weeks postpartum
Title
Adverse Events
Description
Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)
Time Frame
1-6 weeks Postpartum

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women after delivery of neonate
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan C Shepherd, M.D.
Phone
409-772-0312
Email
mcshephe@UTMB.EDU
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Salazar, RN
Phone
409-772-0312
Email
assalaza@utmb.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Saad, M.D.
Organizational Affiliation
UTMB
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. David's North Austin Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Gleason, RN
Phone
512-821-2540
Email
Caroline.Gleason@hcahealthcare.com
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Saad, MD
Phone
409-747-6646
Email
afsaad@utmb.edu
First Name & Middle Initial & Last Name & Degree
Megan C Shepherd, MD
Email
mcshephe@utmb.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide

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