ToRsemide for pOstpartum HYpertension

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-09-09

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.

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Detailed Description

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Conditions

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Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Torsemide

Torsemide 20 mg daily for 5 days

Group Type EXPERIMENTAL

Torsemide

Intervention Type DRUG

Placebo

Placebo 20 mg daily for 5 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Torsemide

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Demadex, torasemide

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes