Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide

Pre-Eclampsia Clinical Trial

Official title:

Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03298802
• Other study ID #: 16-0280
• Status: Recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Eclampsia
• Gestational Hypertension
• Hypertension
• Hypertension, Pregnancy-Induced
• Postpartum Preeclampsia
• Postpartum Pregnancy-Induced Hypertension
• Pre-Eclampsia
• Superimposed Pre-Eclampsia

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