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| ID | Type | Description | Link |
|---|---|---|---|
| NMUK2190 |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crystalloid resuscitation | Active Comparator | Crystalloid (Ringer's lactate) will be delivered before (15min) or after (15min) neuraxial anesthesia |
|
| Colloid resuscitation | Active Comparator | Colloid (6% hydroxyethyl starch ) will be delivered before (15min) or after (15min) neuraxial anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ringer's Lactate | Drug | Ringer's Lactate 8 ml/kg was given intravenously before or after epidural, spinal or CSEA in cesarean section |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) | Immediate after birth (0 min) |
| Measure | Description | Time Frame |
|---|---|---|
| Apgar scoring | One min and 5min after birth. | |
| Umbilical-cord gases analysis | At the time baby was born (0min) | |
| Neonatal sepsis evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| XiaoFeng Shen, MD | Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Maternity and Child Health Care Hospital | Nanjing | Jiangsu | 210004 | China |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Six percent hydroxyethyl starch | Drug | Hydroxyethyl starch (6%) was given before or after epidural, spinal or CSEA in cesarean section |
|
|
| 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) |
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) | 30min after birth |
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) | 1h after birth |
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) | 8h after birth |
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) | 1d after birth |
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) | 1wk after birth |
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) | 1month after birth |