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Correlation Between the Polymorphism ofβ2 AR and the Labor Progress After Labor Analgesia

16. marts 2016 opdateret af: Caijuan Li, Nanjing Maternity and Child Health Care Hospital

Principal Investigator

Labor and delivery is a unique physiological experience of women. Inappropriate length of labor progress during vaginal delivery may produce great risks for mother and fetus. Especially the slow progress is one of the most important reasons for the occurrence of cesarean section during vaginal delivery, which still with a high incidence in recent years.Previous studies have found that there was a significant correlation between the genetic polymorphisms of β 2-adrenergic receptor (β2AR) and the duration of vaginal delivery.Therefore, the researchers intend to investigate the distribution of β2-adrenergic receptor (β2AR) genetic polymorphisms among Chinese parturient and observe the relationship between the genetic polymorphisms and labor process after labor analgesia.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Forventet)

300

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

23 år til 43 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

The parturient undergoing labor analgesia in our hospital. And the eligible parturient aged at 23-43, gestational age 35-42 weeks with an ASA grade I-II, who spontaneously choosing vaginal delivery mode with epidural analgesia.

Beskrivelse

Inclusion Criteria:

  • Nulliparous women
  • Required labor analgesia
  • Chinese
  • Spontaneous labor

Exclusion Criteria:

  • Contraindications for epidural analgesia
  • Allergic to opioids and/or local anesthetics
  • Failed to performing epidural catheterization
  • Organic dysfunction
  • Those who were not willing to or could not finish the whole study at any time
  • Using or used in the past 14 days of the monoamine oxidase inhibitors
  • Alcohol addictive or narcotic dependent patients
  • Subjects with a nonvertex presentation or scheduled induction of labor
  • Twin gestation and breech presentation

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
β2AR Arg16Arg (AA group)
People with β2AR Arg16Arg genotype.
Genetisk: β2AR polymorphism
β2AR Arg16Gly (AG group)
People with β2AR Arg16Gly genotype.
Genetisk: β2AR polymorphism
β2AR Gly16Gly (GG group)
People with β2AR Gly16Gly genotype.
Genetisk: β2AR polymorphism
β2AR Gln27Gln (CC group)
People with β2AR Gln16Gln genotype.
Genetisk: β2AR polymorphism
β2AR Gln27Glu (CG group)
People with β2AR Gln27Glu genotype.
Genetisk: β2AR polymorphism
β2AR Glu27Glu (GG group)
People with β2AR Glu27Glu genotype.
Genetisk: β2AR polymorphism

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
total labor process
Tidsramme: up to about 24h
time from the regular uterus contractions until completed childbirth, assessed up to about 24h
up to about 24h
duration of the first stage
Tidsramme: up to about 20h
time from the regular uterus contractions to full cervix dilation,assessed up to about 20h
up to about 20h
duration of the second stage
Tidsramme: up to about 2h
time from full cervix dilation to the complete childbirth, assessed up to about 2h
up to about 2h
Maternal visual analogue scale
Tidsramme: At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
method of delivery
Tidsramme: At time of placental delivery
At time of placental delivery
At time of placental delivery
Maternal modified Bromage scale
Tidsramme: At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture
Tidsramme: At two hours postpartum
At two hours postpartum
At two hours postpartum
Maternal satisfaction with analgesia
Tidsramme: At two hours postpartum
At two hours postpartum
At two hours postpartum
Use of oxytocin after analgesia
Tidsramme: At twenty-four hours postpartum
At twenty-four hours postpartum
At twenty-four hours postpartum
Neonatal Apgar scale
Tidsramme: At the first and fifth minutes after baby was born
At the first and fifth minutes after baby was born
At the first and fifth minutes after baby was born
Maximal oxytocin dose
Tidsramme: At twenty-four hours postpartum
At twenty-four hours postpartum
At twenty-four hours postpartum
Maternal heart rate, respiratory rate, and blood pressure
Tidsramme: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Neonatal weight
Tidsramme: At delivery
At delivery
At delivery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nanjing Maternity and Child Health Care Hospital

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

1. marts 2016

Primær færdiggørelse (Forventet)

1. april 2016

Studieafslutning (Forventet)

1. maj 2016

Datoer for studieregistrering

Først indsendt

18. februar 2016

Først indsendt, der opfyldte QC-kriterier

9. marts 2016

Først opslået (Skøn)

15. marts 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • NMCHC2016003

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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