Skip to main content
OpenTrials
Completed

NCT Number: NCT02163655

Diuretics for Postpartum High Blood Pressure in Preeclampsia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

IMIP

Recife, Pernambuco, 52020-070, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furosemide

Drug

Furosemide, 20mg pills, will be administered every 24 houras, for a maximum of five days

Other names: Lasix

Placebo

Drug

Placebo pills, identical to the intervention (furosemide pills), will be administered every 24 hour for a maximum of five days

Primary outcomes

  1. Mean blood pressure

    Time frame: from 24 hours after delivery to first 15 days of delivery

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Other

Registry information

Official study title

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

Acronym: DIUPRE

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jun 13, 2014
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.