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Completed

NCT Number: NCT00987701

Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors

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.

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Key information

Conditions

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ringer's Lactate

Drug

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

Other names: Lactated Ringer's solution

Six percent hydroxyethyl starch

Drug

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

Other names: HES/HAES

Primary outcomes

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

    Time frame: Immediate after birth (0 min)

Secondary outcomes

  1. Apgar scoring

    Time frame: One min and 5min after birth.

  2. Umbilical-cord gases analysis

    Time frame: At the time baby was born (0min)

  3. Neonatal sepsis evaluation

    Time frame: One hour after the baby was born

  4. Neonatal antibiotic treatment

    Time frame: One hour after the baby was born

  5. Incidence of maternal side effects

    Time frame: Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women)

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

    Time frame: 30min after birth

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

    Time frame: 1h after birth

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

    Time frame: 8h after birth

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

    Time frame: 1d after birth

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

    Time frame: 1wk after birth

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

    Time frame: 1month after birth

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

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

Acronym: PAFUMIN

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 1, 2009
Registry last updated
Jul 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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