Diuretics for Postpartum High Blood Pressure in Preeclampsia

Preeclampsia Clinical Trial

— DIUPRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163655
• Other study ID #: DIUPRE
• Secondary ID: DIUPRE
• Status: Completed
• Phase: Phase 4
• Start date: March 2014
• Est. completion date: August 2015

Study information

• Verified date: July 2021
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• FUROSEMIDE
Furosemide, 20mg pills, will be administered every 24 houras, for a maximum of five days
• Placebo
Placebo pills, identical to the intervention (furosemide pills), will be administered every 24 hour for a maximum of five days

Locations

Country	Name	City	State
Brazil	IMIP	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Blood pressure control	Absence pf very blood pressure episodes in 24 hours period	From 24 hours after delivery to 15 days
Primary	Mean blood pressure		from 24 hours after delivery to first 15 days of delivery
Secondary	postpartum hospital stay	Time until discharge of the hospital	from 24 hours after delivery to 15 days
Secondary	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
Secondary	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
Secondary	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