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Clinical Trials/NCT04014504
NCT04014504
Completed
N/A

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

Kanuni Sultan Suleyman Training and Research Hospital1 site in 1 country150 target enrollmentJanuary 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Enrollment
150
Locations
1
Primary Endpoint
Neonatal Hearing Screening Test
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
January 1, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pınar Kadirogulları

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

Kanuni Sultan Suleyman Training and Research Hospital

Eligibility Criteria

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,
  • plesanta previa,

Outcomes

Primary Outcomes

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.

Study Sites (1)

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