Diuretics for Postpartum High Blood Pressure in Preeclampsia (DIUPRE)

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

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.

Study Overview

• Status: Completed
• Conditions: Preeclampsia
• Intervention / Treatment: Drug: Placebo; Drug: FUROSEMIDE

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 52020-070
      • IMIP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of very high blood pressure episode	Frequency of very high blood pressure (Systolic blood pressure >180mmHg and diastolic blood pressure >110mmHg) episodes	from 24 hours after delivery until 15 days after delivery
Blood pressure control	Absence pf very blood pressure episodes in 24 hours period	From 24 hours after delivery to 15 days

Collaborators and Investigators

• Sponsor: Instituto Materno Infantil Prof. Fernando Figueira
• Investigators: Study Director: Leila Katz, MD PhD, IMIP

Publications and helpful links

General Publications

• Cursino T, Katz L, Coutinho I, Amorim M. Diuretics vs. placebo for postpartum blood pressure control in preeclampsia (DIUPRE): a randomized clinical trial. Reprod Health. 2015 Aug 5;12:66. doi: 10.1186/s12978-015-0057-0.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: June 9, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (Estimate): June 13, 2014

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: preeclampsia, very high blood pressure, diuretics
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Furosemide
• Other Study ID Numbers: DIUPRE (Other Identifier: Brazil Ministry of Health)