Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors

Cesarean Section Clinical Trial

— PAFUMIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987701
• Other study ID #: NJMU-0932MZ
• Secondary ID: NMUK2190
• Status: Completed
• Phase: N/A
• First received: September 30, 2009
• Last updated: July 26, 2011
• Start date: September 2009
• Est. completion date: May 2011

Study information

• Verified date: July 2011
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Drug:
• Ringer's Lactate
Ringer's Lactate 8 ml/kg was given intravenously before or after epidural, spinal or CSEA in cesarean section
• Six percent hydroxyethyl starch
Hydroxyethyl starch (6%) was given before or after epidural, spinal or CSEA in cesarean section

Locations

Country	Name	City	State
China	The Affiliated Nanjing Maternity and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)		Immediate after birth (0 min)	Yes
Secondary	Apgar scoring		One min and 5min after birth.	Yes
Secondary	Umbilical-cord gases analysis		At the time baby was born (0min)	Yes
Secondary	Neonatal sepsis evaluation		One hour after the baby was born	Yes
Secondary	Neonatal antibiotic treatment		One hour after the baby was born	Yes
Secondary	Incidence of maternal side effects		Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women)	Yes
Secondary	Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)		30min after birth	Yes
Secondary	Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)		1h after birth	Yes
Secondary	Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)		8h after birth	Yes
Secondary	Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)		1d after birth	Yes
Secondary	Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)		1wk after birth	Yes
Secondary	Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)		1month after birth	Yes