Pethidine Analgesia and Neonatal Hearing Screening Test

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04014504
• Other study ID #: 2019.07.07
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: July 2019
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 14 Days

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss
• Newborn Complication

Intervention

Diagnostic Test:
• Neonatal Hearing Screening Test
neonatal hearing screening test results will be evaluated.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Süleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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