Pethidine Analgesia and Neonatal Hearing Screening Test

NCT04014504 | Completed

• 1 other identifier: 2019.07.07
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss; Newborn Complication

Keywords

Newborn Hearing Screening; Otoacoustic emissions; Pethidine; False positive

Outcome Measures

Primary Outcomes (1)

• Neonatal Hearing Screening Test

  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.

  2 week

Study Arms (2)

study group

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.

Diagnostic Test: Neonatal Hearing Screening Test

control group

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.

Diagnostic Test: Neonatal Hearing Screening Test

Interventions

Neonatal Hearing Screening Test DIAGNOSTIC_TEST

neonatal hearing screening test results will be evaluated.

control group; study group

Eligibility Criteria

• Age: 24 Hours - 14 Days
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, M.D, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: July 7, 2019
• First Posted: July 10, 2019
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: July 12, 2019

Record last verified: 2019-07

Locations

TU (1)