Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors

Study Overview
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Brief Summary
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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.

Official Title
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Correlation Between Perineuraxial Anesthesia Fluid Resuscitation in Cesarean Section and Infant Neurobehaviors

Conditions
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Cesarean Section

Intervention / Treatment
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* Drug: Ringer's Lactate
* Drug: Six percent hydroxyethyl starch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Crystalloid resuscitation<br>Crystalloid (Ringer's lactate) will be delivered before (15min) or after (15min) neuraxial anesthesia | Drug: Ringer's Lactate<br>* Ringer's Lactate 8 ml/kg was given intravenously before or after epidural, spinal or CSEA in cesarean section<br>* Other names: Lactated Ringer's solution;|
| Active Comparator: Colloid resuscitation<br>Colloid (6% hydroxyethyl starch ) will be delivered before (15min) or after (15min) neuraxial anesthesia | Drug: Six percent hydroxyethyl starch<br>* Hydroxyethyl starch (6%) was given before or after epidural, spinal or CSEA in cesarean section<br>* Other names: HES/HAES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) |  | Immediate after birth (0 min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 30min after birth | 
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) |  | 1h after birth | 
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) |  | 8h after birth | 
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) |  | 1d after birth | 
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) |  | 1wk after birth | 
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) |  | 1month after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurobehavior, Development, Fluid management, Neuraxial anesthesia