Pethidine Analgesia and Neonatal Hearing Screening Test

July 11, 2019 updated by: Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 33404
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
neonatal hearing screening test results will be evaluated.
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
neonatal hearing screening test results will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Hearing Screening Test
Time Frame: 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.
2 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

July 7, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (Actual)

July 10, 2019

Study Record Updates

Last Update Posted (Actual)

July 12, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019.07.07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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