Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors

Not Applicable

Completed

• Conditions: Cesarean Section
• Interventions: Drug: Ringer's Lactate; Drug: Six percent hydroxyethyl starch

• Registration Number: NCT00987701
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-26
• Last Update Posted: 2011-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crystalloid resuscitation	Ringer's Lactate	Crystalloid (Ringer's lactate) will be delivered before (15min) or after (15min) neuraxial anesthesia
Colloid resuscitation	Six percent hydroxyethyl starch	Colloid (6% hydroxyethyl starch ) will be delivered before (15min) or after (15min) neuraxial anesthesia

Primary Outcome Measures

Name	Time	Method
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)	Immediate after birth (0 min)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Affiliated Nanjing Maternity and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China