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Diuretics for Postpartum High Blood Pressure in Preeclampsia (DIUPRE)

Primary Purpose

Preeclampsia

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
FUROSEMIDE
Placebo
Sponsored by
Instituto Materno Infantil Prof. Fernando Figueira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preeclampsia focused on measuring preeclampsia, very high blood pressure, diuretics

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • IMIP

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

PLACEBO

FUROSEMIDE

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean blood pressure

Secondary Outcome Measures

postpartum hospital stay
Time until discharge of the hospital
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.
frequency of adverse effects
Presence of hypokalemia, polydipsia, headache, mental confusion, muscle pain, tetany, muscle weakness, heart rhythm disturbances and gastrointestinal symptoms;
frequency of maternal complications
Frequency of imminent eclampsia, eclampsia, infection, bleeding manifestations, shock and maternal death.

Full Information

First Posted
June 9, 2014
Last Updated
July 12, 2021
Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
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1. Study Identification

Unique Protocol Identification Number
NCT02163655
Brief Title
Diuretics for Postpartum High Blood Pressure in Preeclampsia
Acronym
DIUPRE
Official Title
Effectiveness of Postpartum Furosemide on Recovery Blood Pressure in Puerperal Women With Severe Preeclampsia: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Materno Infantil Prof. Fernando Figueira

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
preeclampsia, very high blood pressure, diuretics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
PLACEBO: placebo, oral, every 24 hours for maximum 5 days
Arm Title
FUROSEMIDE
Arm Type
Experimental
Arm Description
FUROSEMIDE: 20mg furosemide, oral, every 24 hours for maximum 5 days
Intervention Type
Drug
Intervention Name(s)
FUROSEMIDE
Other Intervention Name(s)
Lasix
Intervention Description
Furosemide, 20mg pills, will be administered every 24 houras, for a maximum of five days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo pills, identical to the intervention (furosemide pills), will be administered every 24 hour for a maximum of five days
Primary Outcome Measure Information:
Title
Mean blood pressure
Time Frame
from 24 hours after delivery to first 15 days of delivery
Secondary Outcome Measure Information:
Title
postpartum hospital stay
Description
Time until discharge of the hospital
Time Frame
from 24 hours after delivery to 15 days
Title
Maintenance of antihypertensive therapy
Description
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.
Time Frame
From 24 hours up to 15 days of delivery
Title
frequency of adverse effects
Description
Presence of hypokalemia, polydipsia, headache, mental confusion, muscle pain, tetany, muscle weakness, heart rhythm disturbances and gastrointestinal symptoms;
Time Frame
From 24 hours to 15 days after delivery
Title
frequency of maternal complications
Description
Frequency of imminent eclampsia, eclampsia, infection, bleeding manifestations, shock and maternal death.
Time Frame
From 24 hours up to 15 days after delivery
Other Pre-specified Outcome Measures:
Title
Frequency of very high blood pressure episode
Description
Frequency of very high blood pressure (Systolic blood pressure >180mmHg and diastolic blood pressure >110mmHg) episodes
Time Frame
from 24 hours after delivery until 15 days after delivery
Title
Blood pressure control
Description
Absence pf very blood pressure episodes in 24 hours period
Time Frame
From 24 hours after delivery to 15 days

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leila Katz, MD PhD
Organizational Affiliation
IMIP
Official's Role
Study Director
Facility Information:
Facility Name
IMIP
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
52020-070
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
26242730
Citation
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.
Results Reference
derived

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Diuretics for Postpartum High Blood Pressure in Preeclampsia

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