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临床试验/NCT03122808
NCT03122808已完成不适用

Intrapartum Uterine Activity Monitoring and Partogram Characteristics: Can They Help Predict Foetuses With Poor Tolerance of Labour?

The Rotunda Hospital1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
264
试验地点
1
主要终点
Rest interval duration

研究概览

简要总结

Excessive uterine activity may be one of several aetiological factors that contribute to depressed neurological function in the newborn. During labour, uterine contractions can compress the fetal cranium at pressures high enough to impair cerebral perfusion. Contraction rates greater than 7 in 15 minutes are associated with an increased risk of neonatal encephalopathy.

The American Congress of Obstetricians and Gynecologists defines uterine tachysystole as more than 5 contractions in 10 minutes, averaged over a 30-minute window. By this definition, excessive uterine activity is common and, at best, a non-specific predictor of depressed neurological function in the newborn. There is a need for predictors of neonatal encephalopathy that are more specific and clinically applicable.

Contraction and relaxation duration are two measures that closely reflect the proposed role of excessive uterine activity in the pathogenesis of neonatal encephalopathy. Prolonged contractions with short relaxation periods result in progressive reductions in fetal cerebral oxygenation. Shorter uterine contraction periods are associated with an increased risk of low umbilical cord potential of hydrogen (pH) values.

Our primary aim is to measure parameters of uterine activity, for example relaxation and contraction duration, and determine their relationship with the risk of neonatal encephalopathy. We will also investigate how measures of uterine activity interact with other measures of labour and fetal well-being, including cervical dilation rates and fetal heart rate patterns. In babies with neonatal encephalopathy, we will investigate the relationship of uterine activity with electrophysiological, radiological and developmental outcomes.

We will perform a retrospective case-control study of babies born in the Rotunda hospital from 2005 until the present. The assessor of the Cardiotocograph (CTG) recordings will be blind to the disease status of the infants. For each recording, every uterine contraction and rest interval will be measured. Summary variables created from these measures will be used to compare the case and control groups. The primary variable will be mean rest interval duration.

详细描述

The advent of therapeutic hypothermia has improved outcomes for babies born with hypoxic-ischemic encephalopathy. However, the risk of death, seizures, cerebral palsy or intellectual impairment remains significant, especially among the most severely affected infants. Prevention remains a promising strategy to reduce the incidence of complications arising from hypoxic-ischaemic neonatal encephalopathy.

Excessive uterine activity may be one of several aetiological factors that contribute to depressed neurological function in the newborn. During labour, uterine contractions can compress the fetal cranium at pressures high enough to impair cerebral perfusion. Contraction rates greater than 7 in 15 minutes are associated with an increased risk of neonatal encephalopathy.

The American Congress of Obstetricians and Gynecologists defines uterine tachysystole as more than 5 contractions in 10 minutes, averaged over a 30-minute window. By this definition, excessive uterine activity is common and, at best, a non-specific predictor of depressed neurological function in the newborn. There is a need for predictors of neonatal encephalopathy that are more specific and clinically applicable.

Contraction and relaxation duration are two measures that closely reflect the proposed role of excessive uterine activity in the pathogenesis of neonatal encephalopathy. Prolonged contractions with short relaxation periods result in progressive reductions in fetal cerebral oxygenation. Shorter uterine contraction periods are associated with an increased risk of low umbilical cord pH values.

Our primary aim is to measure parameters of uterine activity, for example relaxation and contraction duration, and determine their relationship with the risk of neonatal encephalopathy. We will also investigate how measures of uterine activity interact with other measures of labour and fetal well-being, including cervical dilation rates and fetal heart rate patterns. In babies with neonatal encephalopathy, we will investigate the relationship of uterine activity with electrophysiological, radiological and developmental outcomes.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Rest interval duration

时间窗: Whole CTG recording from start of labour to delivery

Expressed as mean, maximum, 90th centile. Individual uterine activity measures will be analysed both as continuous and categorised variables and in terms of minutes elapsed above a certain threshold that is to be determined.

次要结局

  • Rest interval as a percentage of contraction-rest interval cycle(Whole CTG recording from start of labour to delivery)

研究者

发起方
The Rotunda Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Breda Hayes

Consultant Neonatologist

The Rotunda Hospital

研究点 (1)

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