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Pethidine Analgesia and Neonatal Hearing Screening Test

K

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Conditions

Newborn Complication
Hearing Loss

Treatments

Diagnostic Test: Neonatal Hearing Screening Test

Study type

Observational

Funder types

Other

Identifiers

NCT04014504
2019.07.07

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

Female

Ages

24 hours to 14 days old

Volunteers

No Healthy Volunteers

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.

Trial design

150 participants in 2 patient groups

study group
Description:
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.
Treatment:
Diagnostic Test: Neonatal Hearing Screening Test
control group
Description:
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.
Treatment:
Diagnostic Test: Neonatal Hearing Screening Test

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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