Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors (PAFUMIN)
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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 |
- Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: Immediate after birth (0 min) ] [ Designated as safety issue: Yes ]
- 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 |
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| China, Jiangsu | |
| The Affiliated Nanjing Maternity and Child Health Care Hospital | |
| Nanjing, Jiangsu, China, 210004 | |
| 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 Hetastarch Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Plasma Substitutes Blood Substitutes Hematologic Agents |
ClinicalTrials.gov processed this record on May 16, 2013