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Completed

NCT Number: NCT04014504

Pethidine Analgesia and Neonatal Hearing Screening Test

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.

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Key information

Age range

24 hour–14 day

Sex eligibility

Female

Study type

Observational

Primary location

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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,
  • smoking,
  • 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.

Treatment and study plan

Neonatal Hearing Screening Test

Diagnostic Test

neonatal hearing screening test results will be evaluated.

Primary outcomes

  1. Neonatal Hearing Screening Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 10, 2019
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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