Clinical Trial: Epidural Labor Analgesia and Infant Neurobehavior

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Epidural Analgesia for Labor Pain and Infant Neurobehavior

Brief Summary: Infant neurobehavior alteration is predictor of later intelligence development. Many factors would influence or are associated with infant neurobehavior, of which exist or appear during perinatal period. Neuraxial, especially epidural, analgesia to date is the most effective method in relieving labor pain. Although previous studies showed that opioid used in epidural analgesia for labor pain can affect newborn neurobehavior negatively in a dose-escalation associated manner, whether epidural analgesia itself would produce unpredictable effect on newborn neurobehavior is still unknown. Hereby the investigators designed this trial to investigate the hypothesis that epidural analgesia for labor pain control itself would not produce negative effect on infant neurobehavior.

Detailed Summary:
Sponsor: Nanjing Medical University

Current Primary Outcome: Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: Immediate after birth (0 min) ]

Original Primary Outcome: Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: Immediate after birth (0 min), 30min, 2h, 4h, 12h, 24h, 2d, 1wk, 1month, and 6months after birth. ]

Current Secondary Outcome:

  • Apgar scoring [ Time Frame: One min and 5min after birth. ]
  • Umbilical-cord gases analysis [ Time Frame: At the time baby was born (0min) ]
  • Neonatal sepsis evaluation [ Time Frame: One hour after the baby was born ]
  • Neonatal antibiotic treatment [ Time Frame: One hour after the baby was born ]
  • Incidence of maternal side effects [ Time Frame: Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women) ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 10min after birth ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 1h after birth ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 8h after birth ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 1d after birth ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 1wk after birth ]


Original Secondary Outcome:

  • Apgar scoring [ Time Frame: One min and 5min after birth. ]
  • Umbilical-cord gases analysis [ Time Frame: At the time baby was born (0min) ]
  • Neonatal sepsis evaluation [ Time Frame: One hour after the baby was born ]
  • Neonatal antibiotic treatment [ Time Frame: One hour after the baby was born ]
  • Incidence of maternal side effects [ Time Frame: Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women) ]


Information By: Nanjing Medical University

Dates:
Date Received: September 30, 2009
Date Started: September 2009
Date Completion:
Last Updated: July 26, 2011
Last Verified: July 2011