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临床试验/NCT04632017
NCT04632017Unknown不适用

Computerized Cardiotocography Monitoring in Fetuses With Preterm Premature Rupture of Membranes

University of Campania "Luigi Vanvitelli"1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年6月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Preterm birth rate

研究概览

简要总结

Preterm premature rupture of membranes (PPROM) is associated with neonatal complications leading to a high rate of cerebral palsy, sepsis, and death. Choosing the best time of delivery is crucial to improve fetal outcome. The balance is between a premature delivery exposing the infant to all the risk of prematurity, and keeping the baby in utero, prolonging the exposure to an adverse intrauterine milieu. There are no objective and reproducible tools to help in this decision-making process. Techniques most frequently used for fetal surveillance are biased by high inter- and intra-observer variability. Computerized cardiotocography (cCTG) identifies several objective parameters related to fetal heart rate (FHR) to determine fetal well-being. cCTG has been successfully used in fetuses with intrauterine growth restriction, but it has never been used in prospective studies to assess its role in the management of fetuses with PPROM. The investigators designed a case control study to highlight cCTG differences in PPROM pregnancies versus physiological pregnancies, to establish the effectiveness in predicting adverse outcome, and to develop a score to predict neonatal outcome.

详细描述

Preterm premature rupture of membranes (PPROM) occurs in 2 to 3% of pregnancies and is associated with higher maternal and neonatal morbidity and mortality. Neonatal complications are primarily due to prematurity and to ascending infection of the amniotic cavity (chorioamnionitis), leading to a high rate of cerebral palsy, intracranial hemorrhage, sepsis, pneumonia, and death. Every physician is confronted with an extremely difficult and at the same time of paramount importance decision, when it comes to establish the timing of the delivery of a premature fetus with PPROM. The balance is between delivering a premature infant exposed to all the risk of prematurity, and keeping the baby in utero, prolonging the exposure to an adverse intrauterine milieu. At present, there are no objective and reproducible tools to help in this decision-making process. The technique most frequently used for fetal surveillance is cardiotocography (CTG). Assessment of the fetal heart rate is classified subjectively as 'reassuring' or 'not reassuring'. Dawes and Redman have suggested computerized CTG (cCTG), which eliminates inter- and intra-observer variability, identifying several objective parameters to determine fetal well-being. After the multicentre TRUFFLE-Study, cCTG became the best tool to manage fetuses with intrauterine growth restriction (IUGR). However, the use of cCTG has never been investigated in prospective studies to assess its role in the management of fetuses with PPROM. Of note, amniotic fluid concentration of glucose, lactate, interleukin-6 (IL-6), and matrix metalloproteinase-8 (MMP-8) have been associated with neonatal septicemia, chorioamnionitis, preterm birth, and/or fetal inflammatory response syndrome in women with pPROM.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pPROM between 24 and 34 weeks (w)

排除标准

  • multiple pregnancy, structural fetal anomalies, preexisting or gestational diabetes mellitus and\or hypertension, intrauterine growth restriction.

结局指标

主要结局

Preterm birth rate

时间窗: Less than 37 weeks gestation

次要结局

  • Gestational age at delivery(Time of delivery)
  • Low birth weight rate(Time of delivery)
  • Dawes and Redman indices(between 24 and 34 weeks of gestation)
  • Preterm birth rates(Less than 24, 28, 34 weeks gestation)
  • Neonatal death rate(Between birth and 28 days of age)
  • Birth weight(Time of delivery)
  • Composite adverse neonatal outcomes(Between birth and 28 days of age)
  • Maternal outcomes(Between birth and 28 days after the birth)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maddalena Morlando

Assistant Professor

University of Campania "Luigi Vanvitelli"

研究点 (1)

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