- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02708602
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
Betingelser
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
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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