Diuretics for Postpartum High Blood Pressure in Preeclampsia

Study Overview
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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.

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

Official Title
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Effectiveness of Postpartum Furosemide on Recovery Blood Pressure in Puerperal Women With Severe Preeclampsia: a Randomized Clinical Trial

Conditions
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Preeclampsia

Intervention / Treatment
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* Drug: FUROSEMIDE
* Drug: Placebo


Participation Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PLACEBO<br>PLACEBO: placebo, oral, every 24 hours for maximum 5 days | Drug: Placebo<br>* Placebo pills, identical to the intervention (furosemide pills), will be administered every 24 hour for a maximum of five days<br>|
| Experimental: FUROSEMIDE<br>FUROSEMIDE: 20mg furosemide, oral, every 24 hours for maximum 5 days | Drug: FUROSEMIDE<br>* Furosemide, 20mg pills, will be administered every 24 houras, for a maximum of five days<br>* Other names: Lasix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean blood pressure |  | from 24 hours after delivery to first 15 days of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postpartum hospital stay | Time until discharge of the hospital | from 24 hours after delivery to 15 days | 
| Maintenance of antihypertensive therapy | Number of antihypertensive agents used to control blood pressure at hospital discharge; time elapsed to control blood pressure; daily urine output; reduction of edema; length of hospital stay; frequency of adverse effects: hypokalemia, polydipsia, headache, mental confusion, muscle pain, tetany, muscle weakness, heart rhythm disturbances and gastrointestinal symptoms; frequency of maternal complications: imminent eclampsia, eclampsia, infection, bleeding manifestations, shock and maternal death. | From 24 hours up to 15 days of delivery | 
| frequency of adverse effects | Presence of hypokalemia, polydipsia, headache, mental confusion, muscle pain, tetany, muscle weakness, heart rhythm disturbances and gastrointestinal symptoms; | From 24 hours to 15 days after delivery | 
| frequency of maternal complications | Frequency of imminent eclampsia, eclampsia, infection, bleeding manifestations, shock and maternal death. | From 24 hours up to 15 days after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preeclampsia, very high blood pressure, diuretics