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临床试验/NCT00247104
NCT00247104Unknown不适用

The Use of Cranberries in Women With Preterm Premature Rupture of Membranes

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2007年5月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Length (in days) of the latent period

研究概览

简要总结

Cranberries have been proved to reduce the rate of urinary tract infections in a population of women with recurrent urinary tract infections in previous studies. The purpose of the study is to examine the efficacy of cranberries in pregnant women with preterm premature rupture of membranes in a)prolonging the latent period (=the time period between the time the water broke and delivery of the fetus) and b)reduction of infectious morbidity of both the mother and infant.

详细描述

Preterm premature rupture of membranes (PPROM) complicates 2-3.5% of pregnancies and precipitates labor in 30-40% of preterm deliveries. The common practice in early PPROM with no evidence of chorioamnionitis is admission for close surveillance, antibiotic treatment and steroids for fetal lung maturation (until 32 weeks gestation. Intraamniotic infection is evident in up to 75% of women who develop labor during admission. The infection is for the most an ascending infection.

Cranberries have been recognized by the American Indians as a natural means for preventing urinary tract infection. The mechanism of action includes acidification of urine and inhibition of adhesion of pili-harboring bacteria to the transitional epithelium of the urinary tract.

We assume that cranberries will lower the rate of maternal urinary tract infection. Moreover, the active ingredients will pass transplacentally to the fetus, will be secreted in its urine hence, in the amniotic fluid. The active substances would coat the vagina and bring about their effect also in that environment. Having in mind that most if not all chorioamnionitis infections are caused by ascending infection, the cranberries might lengthen the latent period and reduce infectious maternal and neonatal morbidity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double

入排标准

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

入选标准

  • Proven premature rupture of membranes
  • less than 35 weeks of gestation with good obstetrical dating
  • no suspicion of amnionitis
  • signed informed consent

排除标准

  • Known sensitivity / allergy to cranberries
  • Women treated with warfarin
  • Drug intolerance

结局指标

主要结局

Length (in days) of the latent period

Neonatal infection

Respiratory distress

Admission to NICU (in days)

Neonatal complications rate (NEC, IVH etc)

Maternal infections (uterus, UTI)

次要结局

  • Urinary and vaginal flora before and after treatment
  • Vaginal pH before and after treatment
  • Amniotic fluid pH before and after treatment

研究者

申办方类型
Other

研究点 (1)

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