Diuretics for Postpartum High Blood Pressure in Preeclampsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-20

Study Completion Date

2015-08-31

Brief Summary

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The purpose of this study is to determine if furosemide administered after the first 24 hours of delivery, in women with severe peeclampsia and eclampsia accelerates high blood pressure control and diminishes hospital stay.

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Detailed Description

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A placebo-controlled study that will be conducted including 120 postpartum women with severe preeclampsia . Women who are previosuly diuretic users, with renal impairment, hemodynamic instability or with contraindications to diuretic use will be excluded. Informed consent will be obtained from all participants . Patients will be randomized to receive furosemide ( 40mg orally every twenty-four hours ) or placebo for maximum of five days. The variables are systolic and diastolic blood pressure, frequency of very high blood pressure, need for maintenance of antihypertensive therapy , number of antihypertensive agents used to control blood pressure , urine output , length of hospital stay , adverse effects and maternal complications . Except for the study drug, patients will receive all care and monitoring according to the hospital protocol and decision to initiate or modify antihypertensive therapy will be defined by the attending physician, as well as the decision to discharge. If the patient is discharged before five days of the protocol drug, this drug will be stopped. Teh patients may decide to leave the study at any moment. Data will be collected by researches daily. Plan statistical analysis will be performed using the public domain program Epi Info 7.0 and the mean and dispersion measures for numerical variables will be calculated. To compare means obtained every day and between groups will be used analysis of variance ( ANOVA ) . Nominal variables were compared using the X2 test or Fisher if necessary. Be considered significant at p \< 0,05. The risk ratio (RR) is calculated as a measure of the relative risk for the different outcomes , according to furosemide or placebo

Conditions

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Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PLACEBO

PLACEBO: placebo, oral, every 24 hours for maximum 5 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo pills, identical to the intervention (furosemide pills), will be administered every 24 hour for a maximum of five days

FUROSEMIDE

FUROSEMIDE: 20mg furosemide, oral, every 24 hours for maximum 5 days

Group Type EXPERIMENTAL

FUROSEMIDE

Intervention Type DRUG

Furosemide, 20mg pills, will be administered every 24 houras, for a maximum of five days

Interventions

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FUROSEMIDE

Furosemide, 20mg pills, will be administered every 24 houras, for a maximum of five days

Intervention Type DRUG

Placebo

Placebo pills, identical to the intervention (furosemide pills), will be administered every 24 hour for a maximum of five days

Intervention Type DRUG

Other Intervention Names

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Lasix

Eligibility Criteria

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Inclusion Criteria

* Preeclampsia
* Urine output \> 50ml/h
* End of postpartum magnesium sulphate

Exclusion Criteria

* Cronic hypertension
* Bloor pressure \< 140mmHg and \< 90mmHg
* Diuretic use
* Renal impairment
* Diabetes, sickle cell disease ou rheumatologic disease
* Hemodinamic instability
* Potassium \< 3mEq/L
* Contraindications for fusoremide use

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No