ToRsemide for pOstpartum HYpertension

The University of Texas Health Science Center, Houston118 enrolled

Overview

Currently there is no intervention to prevent persistent postpartum hypertension in preeclamptic women. Physiologically, the use of a pharmacokinetically predictable loop-diuretic is a reasonable intervention to increase elimination of extra fluid accumulated secondary to preeclampsia.The purpose of this study is to assess if Torsemide reduces the incidence of persistent postpartum hypertension in preeclamptic women.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

118

Conditions

Preeclampsia

Interventions

TorsemideDRUG

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Postpartum women at ≥ 18 years of age * Antepartum/intrapartum or within 24 hours postpartum diagnosis of either: * Preeclampsia * Preeclampsia with severe features * Preeclampsia superimposed to chronic hypertension Exclusion Criteria: * Chronic hypertension without superimposed preeclampsia * Gestational hypertension * Urine output \< 30 cc/h at time of randomization * Heart failure or pulmonary edema * Hypersensitivity to Torsemide or sulfonylureas * Hypokalemia (serum potassium \< 3 mEq/L) * Preexisting diuretic use within 24 hours prior to randomization

Locations (1)

The University of Texas Health Science Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg

Persistent postpartum hypertension was defined as sustained systolic blood pressure ≥ 150 or diastolic blood pressure ≥ 100 mmHg by postpartum day 5 or at hospital discharge, whichever occurred first.

Time frame: 0-5 days after delivery

Secondary Outcomes

Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg)

Time frame: 0-6 weeks after delivery

Number of Participants Requiring Postpartum Readmission

Time frame: 0-6 weeks after delivery

Length of Hospital Stay After Delivery

Time frame: 0-5 days after delivery

Weight Change

Time frame: at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)

Change in Lower Extremity Edema

Lower extremity edema was assessed by measuring right ankle circumference at 5 centimeters above the medial malleolus.

Time frame: at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)

Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)

Time frame: 7-10 days after delivery

Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)

Data from ClinicalTrials.gov

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