Diuretics for Postpartum High Blood Pressure in Preeclampsia (DIUPRE)

Instituto Materno Infantil Prof. Fernando Figueira

Status and phase: Completed; Phase 4

Conditions: Preeclampsia

Treatments: Drug: Placebo; Drug: FUROSEMIDE

Study type: Interventional

Funder types: Other

Identifiers

NCT02163655

DIUPRE (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 120 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

PLACEBO

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

FUROSEMIDE

Experimental group

Description:

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

Treatment:

Drug: FUROSEMIDE