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Diuretics for Postpartum High Blood Pressure in Preeclampsia (DIUPRE)

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ClinicalTrials.gov Identifier: NCT02163655
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : August 26, 2015
Sponsor:
Information provided by (Responsible Party):
Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira

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.

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: FUROSEMIDE Drug: Placebo Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Postpartum Furosemide on Recovery Blood Pressure in Puerperal Women With Severe Preeclampsia: a Randomized Clinical Trial
Study Start Date : March 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care
Drug Information available for: Furosemide

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 Name: Lasix




Primary Outcome Measures :
  1. Mean blood pressure [ Time Frame: from 24 hours after delivery to first 15 days of delivery ]

Secondary Outcome Measures :
  1. postpartum hospital stay [ Time Frame: from 24 hours after delivery to 15 days ]
    Time until discharge of the hospital

  2. Maintenance of antihypertensive therapy [ Time Frame: From 24 hours up to 15 days of delivery ]
    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.

  3. frequency of adverse effects [ Time Frame: From 24 hours to 15 days after delivery ]
    Presence of hypokalemia, polydipsia, headache, mental confusion, muscle pain, tetany, muscle weakness, heart rhythm disturbances and gastrointestinal symptoms;

  4. frequency of maternal complications [ Time Frame: From 24 hours up to 15 days after delivery ]
    Frequency of imminent eclampsia, eclampsia, infection, bleeding manifestations, shock and maternal death.


Other Outcome Measures:
  1. Frequency of very high blood pressure episode [ Time Frame: from 24 hours after delivery until 15 days after delivery ]
    Frequency of very high blood pressure (Systolic blood pressure >180mmHg and diastolic blood pressure >110mmHg) episodes

  2. Blood pressure control [ Time Frame: From 24 hours after delivery to 15 days ]
    Absence pf very blood pressure episodes in 24 hours period



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163655


Locations
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Brazil
IMIP
Recife, Pernambuco, Brazil, 52020-070
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
Investigators
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Study Director: Leila Katz, MD PhD IMIP

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Leila Katz, PhD, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT02163655     History of Changes
Other Study ID Numbers: DIUPRE
DIUPRE ( Other Identifier: Brazil Ministry of Health )
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: August 26, 2015
Last Verified: August 2015

Keywords provided by Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira:
preeclampsia, very high blood pressure, diuretics

Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension
Hypertension, Pregnancy-Induced
Pregnancy Complications
Vascular Diseases
Cardiovascular Diseases
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action