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| ID | Type | Description | Link |
|---|---|---|---|
| NMUK2191 |
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Infant neurobehavior alteration is predictor of later intelligence development. Many factors would influence or are associated with infant neurobehavior, of which exist or appear during perinatal period. Neuraxial, especially epidural, analgesia to date is the most effective method in relieving labor pain. Although previous studies showed that opioid used in epidural analgesia for labor pain can affect newborn neurobehavior negatively in a dose-escalation associated manner, whether epidural analgesia itself would produce unpredictable effect on newborn neurobehavior is still unknown. Hereby the investigators designed this trial to investigate the hypothesis that epidural analgesia for labor pain control itself would not produce negative effect on infant neurobehavior.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local anesthetic plus opioid 1 | Active Comparator | Local anesthetic (ropivacaine 0.125%) plus first opioid dose (sufentanil 0.3 microgram/ml) delivered peridural space |
|
| Local anesthetic plus opioid 2 | Active Comparator | Local anesthetic (ropivacaine 0.125%) plus second opioid dose (sufentanil 0.4 microgram/ml) delivered peridural space |
|
| Local anesthetic plus opioid 3 | Active Comparator | Local anesthetic (ropivacaine 0.125%) plus third opioid dose (sufentanil 0.5 microgram/ml) delivered peridural space |
|
| Local anesthetic 1 plus opioid | Active Comparator | First local anesthetic dose (ropivacaine 0.0625%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space |
|
| Local anesthetic 2 plus opioid | Active Comparator | Second local anesthetic dose (ropivacaine 0.1875%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine and sufentanil | Drug | Ropivacaine 0.125% plus sufentanil 0.3 microgram |
|
| 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 |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Local anesthetic 3 plus opioid | Active Comparator | Third local anesthetic dose (ropivacaine 0.25%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space |
|
| Ropivacaine and sufentanil | Drug | Ropivacaine 0.125% plus sufentanil 0.4 microgram |
|
|
| Ropivacaine and sufentanil | Drug | Ropivacaine 0.125% plus sufentanil 0.5 microgram |
|
|
| Ropivacaine and sufentanil | Drug | Ropivacaine 0.0625% plus sufentanil 0.4 microgram |
|
|
| Ropivacaine and sufentanil | Drug | Ropivacaine 0.1875% plus sufentanil 0.4 microgram |
|
|
| Ropivacaine and sufentanil | Drug | Ropivacaine 0.25% plus sufentanil 0.4 microgram |
|
|
| 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) | 10min 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 |
| D000588 |
| Amines |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |