Correlation Between the Polymorphism ofβ2 AR and the Labor Progress After Labor Analgesia
16. mars 2016 oppdatert 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.
Studieoversikt
Studietype
Observasjonsmessig
Registrering (Forventet)
300
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
23 år til 43 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2016
Primær fullføring (Forventet)
1. april 2016
Studiet fullført (Forventet)
1. mai 2016
Datoer for studieregistrering
Først innsendt
18. februar 2016
Først innsendt som oppfylte QC-kriteriene
9. mars 2016
Først lagt ut (Anslag)
15. mars 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. mars 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. mars 2016
Sist bekreftet
1. mars 2016
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- NMCHC2016003
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