- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04014504
Pethidine Analgesia and Neonatal Hearing Screening Test
11. juli 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
150
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Istanbul, Kalkun, 33404
- Kanuni Sultan Suleyman Training and Research Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 dag til 2 uger (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
term singleton pregnancy,Gave birth at 37-41 weeks of gestation, without chronic internal disease,Pregnant women were included in the study.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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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.
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neonatal hearing screening test results will be evaluated.
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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.
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neonatal hearing screening test results will be evaluated.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Neonatal Hearing Screening Test
Tidsramme: 2 week
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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
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2017
Primær færdiggørelse (Faktiske)
1. januar 2018
Studieafslutning (Faktiske)
1. januar 2018
Datoer for studieregistrering
Først indsendt
7. juli 2019
Først indsendt, der opfyldte QC-kriterier
8. juli 2019
Først opslået (Faktiske)
10. juli 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. juli 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. juli 2019
Sidst verificeret
1. juli 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2019.07.07
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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