Correlation Between the Polymorphism ofβ2 AR and the Labor Progress After Labor Analgesia
16 mars 2016 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Anticipé)
300
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
23 ans à 43 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
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.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
total labor process
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
method of delivery
Délai: At time of placental delivery
|
At time of placental delivery
|
At time of placental delivery
|
|
Maternal modified Bromage scale
Délai: 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
Délai: At two hours postpartum
|
At two hours postpartum
|
At two hours postpartum
|
|
Maternal satisfaction with analgesia
Délai: At two hours postpartum
|
At two hours postpartum
|
At two hours postpartum
|
|
Use of oxytocin after analgesia
Délai: At twenty-four hours postpartum
|
At twenty-four hours postpartum
|
At twenty-four hours postpartum
|
|
Neonatal Apgar scale
Délai: 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
Délai: At twenty-four hours postpartum
|
At twenty-four hours postpartum
|
At twenty-four hours postpartum
|
|
Maternal heart rate, respiratory rate, and blood pressure
Délai: 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
Délai: At delivery
|
At delivery
|
At delivery
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2016
Achèvement primaire (Anticipé)
1 avril 2016
Achèvement de l'étude (Anticipé)
1 mai 2016
Dates d'inscription aux études
Première soumission
18 février 2016
Première soumission répondant aux critères de contrôle qualité
9 mars 2016
Première publication (Estimation)
15 mars 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
17 mars 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 mars 2016
Dernière vérification
1 mars 2016
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- NMCHC2016003
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