Clinical trial NCT02163655: Diuretics for Postpartum High Blood Pressure in Preeclampsia
Official title: Effectiveness of Postpartum Furosemide on Recovery Blood Pressure in Puerperal Women with Severe Preeclampsia: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preeclampsia
Keywords: preeclampsia, very high blood pressure, diuretics
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Mean blood pressure
timeFrame: from 24 hours after delivery to first 15 days of delivery
Secondary outcomes:
measure: postpartum hospital stay
timeFrame: from 24 hours after delivery to 15 days
measure: Maintenance of antihypertensive therapy
timeFrame: From 24 hours up to 15 days of delivery
measure: frequency of adverse effects
timeFrame: From 24 hours to 15 days after delivery
measure: frequency of maternal complications
timeFrame: From 24 hours up to 15 days after delivery
Other outcomes:
measure: Frequency of very high blood pressure episode
timeFrame: from 24 hours after delivery until 15 days after delivery
measure: Blood pressure control
timeFrame: From 24 hours after delivery to 15 days
Locations:
city: Recife
country: Brazil
facility: IMIP
state: Pernambuco
Study officials:
affiliation: IMIP
name: Leila Katz, MD PhD
role: STUDY_DIRECTOR
References:
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.