Pethidine Analgesia and Neonatal Hearing Screening Test

Completed

• Conditions: Hearing Loss; Newborn Complication
• Interventions: Diagnostic Test: Neonatal Hearing Screening Test

• Registration Number: NCT04014504
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2018-01-01
• Study Completion: 2018-01-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-07
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-10
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group	Neonatal Hearing Screening Test	The results of the hearing screening test of the beats of the patients who have undergone pethidine in the active phase of labor will be examined. the results will be reported as passed - remained; the false positivity rate according to the retest of the remaining group is to be looked at.
control group	Neonatal Hearing Screening Test	In the active phase of labor, hearing screening test results of beats of pediatric patients will be evaluated. the results will be reported as passed - remained; the false positivity rate according to the retest of the remaining group is to be looked at. control group.

Primary Outcome Measures

Name	Time	Method
Neonatal Hearing Screening Test	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.

Trial Locations

Locations (1)

Kanuni Sultan Süleyman Training and Research Hospital; 🇹🇷 Istanbul, Turkey