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临床试验/NCT02163655
NCT02163655已完成4 期

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

Instituto Materno Infantil Prof. Fernando Figueira1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年6月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Mean blood pressure

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Preeclampsia
  • Urine output > 50ml/h
  • End of postpartum magnesium sulphate

排除标准

  • 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

研究组 & 干预措施

PLACEBO

Placebo Comparator

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

干预措施: Placebo (Drug)

FUROSEMIDE

Experimental

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

干预措施: FUROSEMIDE (Drug)

结局指标

主要结局

Mean blood pressure

时间窗: from 24 hours after delivery to first 15 days of delivery

次要结局

  • Maintenance of antihypertensive therapy(From 24 hours up to 15 days of delivery)
  • frequency of maternal complications(From 24 hours up to 15 days after delivery)
  • postpartum hospital stay(from 24 hours after delivery to 15 days)
  • frequency of adverse effects(From 24 hours to 15 days after delivery)

研究者

发起方
Instituto Materno Infantil Prof. Fernando Figueira
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leila Katz

PhD

Instituto Materno Infantil Prof. Fernando Figueira

研究点 (1)

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