Pre-Eclampsia Clinical Trial
Official title:
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | St. David's North Austin Medical Center | Austin | Texas |
United States | University of Texas Medical Branch | Galveston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston |
United States,
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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