Clinical trial NCT00987701: Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors
Official title: Correlation Between Perineuraxial Anesthesia Fluid Resuscitation in Cesarean Section and Infant Neurobehaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: Neurobehavior
Development
Fluid management
Neuraxial anesthesia
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2009-10-01
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Early change in neurobehavior is strongly associated with the intelligence development of children. Previous studies reported that cesarean section itself could influence the later development of children. In addition, neuraxial anesthesia including epidural, spinal and combined spinal epidural anesthesia (CSEA) are the major forms used during cesarean delivery, and these anesthesia techniques will undoubtedly evoke hypotension and corresponding hemodynamic alteration, of which would result in decreasing in umbilical placental insufficiency and fetus hypoxia leading to early abnormality of neurobehaviors in infants. Fluid management, such as crystalloid and colloid, is the common ones given before or / and after neuraxial anesthesia to prevent or reverse hypotension. However, it is still unknown whether the perineuraxial anesthesia fluid resuscitation could improve the neurobehavior scorings, and could produce positive effect on later intelligence development. Herein the investigators hypothesized that effective perineuraxial anesthesia fluid management during cesarean section would prevent the occurrence of hypotension and improve infant's neurobehavior scorings.


Eligibility criteria: Inclusion Criteria:

* 21-40 yr
* First time of delivery
* ASA status I-II
* No premature
* No genetic and infectious diseases
* Chinese

Exclusion Criteria:

* \< 21 yr
* \> 40 yr
* Subjects with cardiac and pulmonary disorders
* Dislocation of placenta
* Pregnant hypertension
* Allergy to local anesthetics
* Unwilling to cooperation
* With significant delivery side effects

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: 30min 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
measure: Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
timeFrame: 1month 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: