- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03298802
Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide
December 1, 2023 updated by: The University of Texas Medical Branch, Galveston
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
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.
|
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:
|
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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of readmission and/or triage visits
Time Frame: 1-6 weeks postpartum
|
Any visit in the hospital
|
1-6 weeks postpartum
|
Need for additional antihypertensive therapy
Time Frame: 1-6 weeks postpartum
|
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
Time Frame: 1-6 weeks postpartum
|
Days that patient required to be in-house in the postpartum period
|
1-6 weeks postpartum
|
Total Additional doses of anti-hypertensive therapy
Time Frame: 1-6 weeks postpartum
|
Addition of total doses that patient received in the postpartum period
|
1-6 weeks postpartum
|
Elevation of blood pressure >150/90
Time Frame: 1-6 weeks postpartum
|
Hypertension definition in the postpartum period
|
1-6 weeks postpartum
|
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
|
1-6 weeks postpartum
|
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.
|
1-6 weeks postpartum
|
Adverse Events
Time Frame: 1-6 weeks Postpartum
|
Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis)
|
1-6 weeks Postpartum
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Benjamin Bush, M.D., UTMB
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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