Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors (PAFUMIN)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00987701
First received: September 30, 2009
Last updated: July 26, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Cesarean Section
Drug: Ringer's Lactate
Drug: Six percent hydroxyethyl starch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Correlation Between Perineuraxial Anesthesia Fluid Resuscitation in Cesarean Section and Infant Neurobehaviors

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: Immediate after birth (0 min) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Apgar scoring [ Time Frame: One min and 5min after birth. ] [ Designated as safety issue: Yes ]
  • Umbilical-cord gases analysis [ Time Frame: At the time baby was born (0min) ] [ Designated as safety issue: Yes ]
  • Neonatal sepsis evaluation [ Time Frame: One hour after the baby was born ] [ Designated as safety issue: Yes ]
  • Neonatal antibiotic treatment [ Time Frame: One hour after the baby was born ] [ Designated as safety issue: Yes ]
  • Incidence of maternal side effects [ Time Frame: Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women) ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 30min after birth ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 1h after birth ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 8h after birth ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 1d after birth ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 1wk after birth ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 1month after birth ] [ Designated as safety issue: Yes ]

Enrollment: 5000
Study Start Date: September 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Crystalloid resuscitation
Crystalloid (Ringer's lactate) will be delivered before (15min) or after (15min) neuraxial anesthesia
Drug: Ringer's Lactate
Ringer's Lactate 8 ml/kg was given intravenously before or after epidural, spinal or CSEA in cesarean section
Other Name: Lactated Ringer's solution
Active Comparator: Colloid resuscitation
Colloid (6% hydroxyethyl starch ) will be delivered before (15min) or after (15min) neuraxial anesthesia
Drug: Six percent hydroxyethyl starch
Hydroxyethyl starch (6%) was given before or after epidural, spinal or CSEA in cesarean section
Other Name: HES/HAES

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00987701

Locations
China, Jiangsu
The Affiliated Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Chair: XiaoFeng Shen, MD Nanjing Medical University
  More Information

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00987701     History of Changes
Other Study ID Numbers: NJMU-0932MZ, NMUK2190
Study First Received: September 30, 2009
Last Updated: July 26, 2011
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Neurobehavior
Development
Fluid management
Neuraxial anesthesia

Additional relevant MeSH terms:
Anesthetics
Hydroxyethyl Starch Derivatives
Blood Substitutes
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Plasma Substitutes
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014