Clinical trial NCT00987441: Epidural Labor Analgesia and Infant Neurobehavior
Official title: Epidural Analgesia for Labor Pain and Infant Neurobehavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Neurobehavior
Epidural analgesia
Local anesthetic
Opioid
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2009-10-01
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* \>18years and \<45years
* Spontaneous labor
* Analgesia request

Exclusion Criteria:

* Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
* Participants younger than 18 years or older than 45 years
* 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 were excluded for their influence on the analgesic efficacy of the epidural analgesics
* Subjects with a nonvertex presentation or scheduled induction of labor

Primary outcomes:
measure: Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
timeFrame: Immediate after birth (0 min)
Secondary outcomes:
measure: Apgar scoring
timeFrame: One min and 5min after birth.
measure: Umbilical-cord gases analysis
timeFrame: At the time baby was born (0min)
measure: Neonatal sepsis evaluation
timeFrame: One hour after the baby was born
measure: Neonatal antibiotic treatment
timeFrame: One hour after the baby was born
measure: Incidence of maternal side effects
timeFrame: Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women)
measure: Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
timeFrame: 10min after birth
measure: Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
timeFrame: 1h after birth
measure: Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
timeFrame: 8h after birth
measure: Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
timeFrame: 1d after birth
measure: Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
timeFrame: 1wk after birth
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_CHAIR
References: