NCT00987701

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 27, 2011

Status Verified

July 1, 2011

Enrollment Period

1.7 years

First QC Date

September 30, 2009

Last Update Submit

July 26, 2011

Conditions

Cesarean Section

Keywords

NeurobehaviorDevelopmentFluid managementNeuraxial anesthesia

Outcome Measures

Primary Outcomes (1)

  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

    Immediate after birth (0 min)

Secondary Outcomes (11)

  • 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)

  • +6 more secondary outcomes

Study Arms (2)

Crystalloid resuscitation

ACTIVE COMPARATOR

Crystalloid (Ringer's lactate) will be delivered before (15min) or after (15min) neuraxial anesthesia

Drug: Ringer's Lactate

Colloid resuscitation

ACTIVE COMPARATOR

Colloid (6% hydroxyethyl starch ) will be delivered before (15min) or after (15min) neuraxial anesthesia

Drug: Six percent hydroxyethyl starch

Interventions

Ringer's LactateDRUG

Ringer's Lactate 8 ml/kg was given intravenously before or after epidural, spinal or CSEA in cesarean section

Also known as: Lactated Ringer's solution
Crystalloid resuscitation
Six percent hydroxyethyl starchDRUG

Hydroxyethyl starch (6%) was given before or after epidural, spinal or CSEA in cesarean section

Also known as: HES/HAES
Colloid resuscitation

Eligibility Criteria

Age21 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • First time of delivery
  • ASA status I-II
  • No premature
  • No genetic and infectious diseases
  • Chinese

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • XiaoFeng Shen, MD

    Nanjing Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 1, 2009

Study Start

September 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 27, 2011

Record last verified: 2011-07

Locations

CN(1)