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临床试验/CTRI/2024/05/067226
CTRI/2024/05/067226尚未招募不适用

Prediction Of Neonatal Acidemia At Birth With Intrapartum Total Reperfusion Time On Fetal Cardiotocogram KAHERS DR Prabhakar Kore Hospital, Belagavi- A One Year Case Control Study

Korapala Vyshnavi1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2024年5月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
350
试验地点
1
主要终点
To Study The Predictive Ability Of Total Intrapartum Fetal Reperfusion Time On Fetal Cardiotocogram As A Predictor Of Neonatal Acidemia At Birth

研究概览

简要总结

NEED FOR THE STUDY:

There has been no fetal parameter that can classify fetal acidemia with a high discrimination ability till now.Recent publications have analysed the importance of deceleration physiology and use parameters such as the deceleration area,that reports accumulated hypoxemia[7,8]. Acidemia at the time of birth is a risk factor for neonatal morbidity including neurological injury

Hypoxic ischemic encephalopathy

Meconium aspiration syndrome

Neonatal seizure

Cerebral palsy

Neonatal mortality

It is essential to know about the fetal time available to recovering between deceleration and fetal ability to repeatedly activate the chemoreflex[.To measure total intrapartum fetal reperfusion time(fetal resilience) in CTG before delivery and assess their association with neonatal acidaemia among term infants.

As per the recent research,measurement of total intrapartum reperfusion time(fetal resilience)is a promising parameter on CTG which is predictive of neonatal acidemia at birth than the type of deceleration

DATA COLLECTION PROCEDURE:

The steps used for data collection are as follows:

After obtaining the approval from ethical committee and a written informed consent,

Subjects are recruited according to the inclusion and exclusion criteria

A detailed history with physical examination is taken

The 30min trace recording CTG is analysed

Total reperfusion time is calculated

Umbilical artery cord blood gas analysis at the time of delivery is obtained

Neonates with cord blood PH <=7.2are considered as cases and those with PH  > 7.2 are treated as  Controls

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Deceleration Pattern In Electronic Fetal Monitoring(2 Or More Decelerations In The Last 30 Minutes)
  • Term Gestation (37 To 42 Weeks)
  • Cephalic Presentation
  • No Fetal Anomalies.

排除标准

  • Uterine Rupture
  • Cord Prolapse
  • Shoulder Dystocia
  • Less Than 30 Minutes Trace Of Electronic Fetal Monitoring
  • Recurrent Loss Of Focus In Evaluation Of Electronic Fetal Monitoring.

结局指标

主要结局

To Study The Predictive Ability Of Total Intrapartum Fetal Reperfusion Time On Fetal Cardiotocogram As A Predictor Of Neonatal Acidemia At Birth

时间窗: 42 Weeks

次要结局

  • To Compare The Predictive Ability Of Total Intrapartum Reperfusion Time With Total Deceleration Area(42 Weeks)

研究者

发起方
Korapala Vyshnavi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Korapala Vyshnavi

Jawaharlal Nehru Medical College, KLE University

研究点 (1)

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