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临床试验/NCT04014504
NCT04014504已完成不适用

Effect of Pethidine Analgesia on False Positivity in Neonatal Hearing Screening Test

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Neonatal Hearing Screening Test

研究概览

简要总结

Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well known that false positivity in newborn hearing screening increases cost and maternal anxiety and anxiety. There is still widespread concern about the use of opoid analgesics to relieve pain during labor. The aim of this study was to determine the effects of pethidine administered during labor on neonatal hearing screening test false positivity rates.

详细描述

The study group consisted of patients receiving 50 mg intramuscular (I.M) pethidine at the beginning of the active phase of labor and the control group consisted of patients not receiving pethidine. Newborns were evaluated by otoacoustic emission (OAE) test. The OAE test was performed before the patients were discharged. Perinatal and neonatal variables and test results were recorded and the relationship between false positivity and pethidine use was evaluated.

研究设计

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

入排标准

年龄范围
24 Hours 至 14 Days(Child)
性别
Female
接受健康志愿者

入选标准

  • term singleton pregnancy,
  • Gave birth at 37-41 weeks of gestation,
  • without chronic internal disease,
  • Pregnant women were included in the study.

排除标准

  • Newborn hospitalized in intensive care,
  • congenital / chromosomal anomaly,
  • congenital CMV infection,
  • facial / ear deformities,
  • family with hearing problems,
  • those with hyperbilirunemia,
  • tested at <12 hours after birth,
  • maternal infection,
  • Diabetes mellitus, recurrent abortion,
  • plesanta previa,
  • prolonged premature rupture of the membrane (more than 12 hours), epidural -analgesia and
  • newborns who were at risk of asphyxia hypoxia were excluded from the study.

结局指标

主要结局

Neonatal Hearing Screening Test

时间窗: 2 week

neonatal hearing screening test results will be evaluated. will be reported as left or passed. The "pass'' en response observed in the hearing screening device indicates that the baby passed the screening test, and the" refer "response indicates that the baby has failed.

次要结局

未报告次要终点

研究者

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

Pınar Kadirogulları

principal investigator, M.D, Department of Obstetrics and Gynecology

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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