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

16 mars 2016 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Förväntat)

300

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

23 år till 43 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
β2AR Arg16Arg (AA group)
People with β2AR Arg16Arg genotype.
β2AR Arg16Gly (AG group)
People with β2AR Arg16Gly genotype.
β2AR Gly16Gly (GG group)
People with β2AR Gly16Gly genotype.
β2AR Gln27Gln (CC group)
People with β2AR Gln16Gln genotype.
β2AR Gln27Glu (CG group)
People with β2AR Gln27Glu genotype.
β2AR Glu27Glu (GG group)
People with β2AR Glu27Glu genotype.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
total labor process
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
method of delivery
Tidsram: At time of placental delivery
At time of placental delivery
At time of placental delivery
Maternal modified Bromage scale
Tidsram: 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
Tidsram: At two hours postpartum
At two hours postpartum
At two hours postpartum
Maternal satisfaction with analgesia
Tidsram: At two hours postpartum
At two hours postpartum
At two hours postpartum
Use of oxytocin after analgesia
Tidsram: At twenty-four hours postpartum
At twenty-four hours postpartum
At twenty-four hours postpartum
Neonatal Apgar scale
Tidsram: 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
Tidsram: At twenty-four hours postpartum
At twenty-four hours postpartum
At twenty-four hours postpartum
Maternal heart rate, respiratory rate, and blood pressure
Tidsram: 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
Tidsram: At delivery
At delivery
At delivery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2016

Primärt slutförande (Förväntat)

1 april 2016

Avslutad studie (Förväntat)

1 maj 2016

Studieregistreringsdatum

Först inskickad

18 februari 2016

Först inskickad som uppfyllde QC-kriterierna

9 mars 2016

Första postat (Uppskatta)

15 mars 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

17 mars 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 mars 2016

Senast verifierad

1 mars 2016

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • NMCHC2016003

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