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临床试验/NCT01507974
NCT01507974已完成不适用

The Efficacy of Preventive Antibiotic Treatment During the Puerperium Among Pregnant Women With Recurrent Urinary Tract Infections

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2012年1月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
220
试验地点
1
主要终点
Urinary tract complications

研究概览

简要总结

Urinary tract infection is the most common bacterial infection during pregnancy. Asymptomatic bacteriuria is the most common infection, in up to 8% of the population. Symptomatic infection may cause cystitis or cause pyelonephritis.

Among pregnant women with recurrent bacteriuria, preventive antibiotic treatment has been found to be efficacious in reducing the bacteriuria rate and the complications.

the changes of the urinary tract which appear during pregnancy usually resolve up to 3 months post-partum.

The purpose of this study is to examine the efficacy of preventive antibiotic treatment during the puerperium.

详细描述

During pregnancy functional modifications in the urinary tract influence the function of the urinary tract system. Those changes raise the risk of urinary tract infections. The most common bacterial infections during pregnancy are urinary tract infections. Actually, asymptomatic bacteriuria is the most common infection in up to 8% of the population. Symptomatic infection may cause cystitis or include the renal calyces and parenchyma and cause pyelonephritis. There are few common protocols for bacteriuria treatment. The recurrence rate after treatment is 30%. Preventive treatment with nitrofurantoin has been demonstrated to be effective, although there is a small risk to acute respiratory distress which resolved with cessation of the treatment. Renal infection is the most common serious infection during pregnancy. Complication of renal infection can lead to ARDS or urosepsis. Renal infection usually develops during the second trimester and has been related to prim parity and young women.

About 20% of women will deteriorate to renal insufficiency. 30-40% of cases will be followed with recurrent bacteriuria later on, for this reason, a preventive treatment is recommended until delivery. In previous studies the preventive treatment reduced the bacteriuria rate from 38% to 8%.

After delivery, the morphological changes including edema, bladder hyperemia and a raise in the urinary volume, pass away up to 3 months post partum. There is only slight information regarding the rate of bacteriuria during puerperium, most of the information relates to the early puerperium period. In addition, the consequences of such infection are unknown.

The aim of this study is to estimate the efficacy of preventive antibiotic treatment during the puerperium.

Objectives

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women with two or more episodes of bacteriuria or one episode of pyelonephritis during pregnancy.

排除标准

  • Women with malformations of the urinary tract
  • women with risk factors to urinary tract infections, for example DIABETES MELLITUS, REFLUX.
  • Women with urinary tract infection caused by resistant bacteria (to conventional treatment)

研究组 & 干预措施

preventive antibiotic treatment

Active Comparator

The women in this arm will receive preventive antibiotic treatment after the delivery to 6 weeks

干预措施: Preventive antibiotic treatment- CEPHALEXIN (Drug)

preventive antibiotic treatment

Active Comparator

The women in this arm will receive preventive antibiotic treatment after the delivery to 6 weeks

干预措施: PREVENTIVE TREATMENT- AMOXICILLIN (Drug)

preventive antibiotic treatment

Active Comparator

The women in this arm will receive preventive antibiotic treatment after the delivery to 6 weeks

干预措施: Preventive antibiotic treatment- NITROFURANTOIN (Drug)

preventive antibiotic treatment

Active Comparator

The women in this arm will receive preventive antibiotic treatment after the delivery to 6 weeks

干预措施: PREVENTIVE TREATMENT- AMOXICILLIN AND CLAVULANATE POTASSIUM (Drug)

preventive antibiotic treatment

Active Comparator

The women in this arm will receive preventive antibiotic treatment after the delivery to 6 weeks

干预措施: PREVENTIVE TREATMENT- CEFUROXIME (Drug)

preventive antibiotic treatment

Active Comparator

The women in this arm will receive preventive antibiotic treatment after the delivery to 6 weeks

干预措施: PREVENTIVE TREATMENT SULFAMETHOXAZOLE AND TRIMETHOPRIM (Drug)

结局指标

主要结局

Urinary tract complications

时间窗: 6 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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