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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03298802
Other study ID # 16-0280
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 21, 2017
Est. completion date August 30, 2024

Study information

Verified date December 2023
Source The University of Texas Medical Branch, Galveston
Contact Megan C Shepherd, M.D.
Phone 409-772-0312
Email mcshephe@UTMB.EDU
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 612
Est. completion date August 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design


Intervention

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.
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

Locations

Country Name City State
United States St. David's North Austin Medical Center Austin Texas
United States University of Texas Medical Branch Galveston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of readmission and/or triage visits Any visit in the hospital 1-6 weeks postpartum
Primary Need for additional antihypertensive therapy Requiring additional antihypertensive agents in the postpartum period 1-6 weeks postpartum
Secondary Length of hospital stay Days that patient required to be in-house in the postpartum period 1-6 weeks postpartum
Secondary Total Additional doses of anti-hypertensive therapy Addition of total doses that patient received in the postpartum period 1-6 weeks postpartum
Secondary Elevation of blood pressure >150/90 Hypertension definition in the postpartum period 1-6 weeks postpartum
Secondary 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
Secondary 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
Secondary Adverse Events Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis) 1-6 weeks Postpartum
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