ToRsemide for pOstpartum HYpertension

Study Overview
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Brief Summary
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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.

Official Title
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Torsemide for the Prevention of Persistent Postpartum Hypertension in Preeclamptic Women: A Randomized, Placebo-Control Trial

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: Torsemide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Torsemide<br>Torsemide 20 mg daily for 5 days | Drug: Torsemide<br> <br> * Other names: Demadex, torasemide;|
| Placebo Comparator: Placebo<br>Placebo 20 mg daily for 5 days | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0-5 days after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg) |  | 0-6 weeks after delivery | 
| Number of Participants Requiring Postpartum Readmission |  | 0-6 weeks after delivery | 
| Length of Hospital Stay After Delivery |  | 0-5 days after delivery | 
| Weight Change |  | 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. | 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) |  | 7-10 days after delivery | 
| Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg) |  | 6 weeks after delivery | 
| Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels) |  | 0-5 days after delivery | 
| Number of Participants With Side Effects of Therapy - Decreased Breast Milk |  | 0-5 days after delivery | 
| Number of Participants With Severe Composite Maternal Morbidity | Severe composite maternal morbidity is defined as having any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy, or maternal death. | 0-6 weeks after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preeclampsia, puerperium