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CompletedNCT04014504Updated Jul 12, 2019

Pethidine Analgesia and Neonatal Hearing Screening Test

An observational study in Hearing Loss and Newborn Complication, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 24 Hours to 14 Days. Per ClinicalTrials.gov, last updated 2019-07-12.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
150
Ages
24 Hours to 14 Days
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Hearing Loss
  • Newborn Complication

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Keywords

  • Newborn Hearing Screening
  • Otoacoustic emissions
  • Pethidine
  • False positive
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In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's enrollment of 150 is above the median of 87 across 270 observational studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 216 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
24 Hours to 14 Days
Sexes eligible
Female
Accepts healthy volunteers
No
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.

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

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

Observational model
Case-control
Time perspective
Retrospective
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testNeonatal Hearing Screening Test

    neonatal hearing screening test results will be evaluated.

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What researchers measure

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.

    Time frame: 2 week

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Study locations

1 site
  • Kanuni Sultan Süleyman Training and Research Hospital
    Istanbul, 33404, Turkey
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04014504
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Responsible party
Pınar Kadirogulları (principal investigator, M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Jul 10, 2019
Start date
Jan 1, 2017
Primary completion
Jan 1, 2018
Completion
Jan 1, 2018
Last update
Jul 12, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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