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| ID | Type | Description | Link |
|---|---|---|---|
| NSR02970 |
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| Name | Class |
|---|---|
| HRSA/Maternal and Child Health Bureau | FED |
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Epidural analgesia in the early stage of labor at cervix < 4.0cm was considered as a risk period for increasing the rate of cesarean delivery. The more recent studies and the investigators' previous data indicated epidural analgesia can be performed as early as the cervical dilation approximately 2.0cm. The investigators hypothesized that different cervix diameter had different rate of cesarean delivery. This trial would investigate the correlation amongst different cervical dilation and the risk of cesarean section in nulliparous women at term.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Epidural analgesia initiated at the cervix 0cm |
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| 2 | Active Comparator | Epidural analgesia initiated at the cervix 0.5cm |
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| 3 | Active Comparator | Epidural analgesia initiated at the cervix 1.0cm |
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| 4 | Active Comparator | Epidural analgesia initiated at the cervix 1.5cm |
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| 5 | Active Comparator | Epidural analgesia initiated at the cervix 2.0cm |
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| 6 | Active Comparator | Epidural analgesia initiated at the cervix 3.0cm |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural labor analgesia | Procedure | Epidural analgesia initiated at the onset of regular uterine contraction |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of cesarean delivery | 10 min after successful vaginal delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of instrument-assisted delivery | 10 min after successful vaginal delivery | |
| Indications of cesarean delivery | 10 min after cesarean section | |
| Maternal Visual Analog Scale (VAS) rating of pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| XiaoFeng Shen, MD | Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Maternal and Child Health Care Hospital | Nanjing | Jiangsu | 210004 | China |
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| 7 | Active Comparator | Epidural analgesia initiated at the cervix 4.0cm |
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| 8 | Active Comparator | Epidural analgesia initiated at the cervix 5.0cm |
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| Epidural labor analgesia | Procedure | Epidural analgesia initiated at the cervix diameter 0.5cm |
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| Epidural labor analgesia | Procedure | Epidural analgesia initiated at the cervix diameter 1.0cm |
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| Epidural labor analgesia | Procedure | Epidural analgesia initiated at the cervix diameter 1.5cm |
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| Epidural labor analgesia | Procedure | Epidural analgesia initiated at the cervix diameter 2.0cm |
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| Epidural labor analgesia | Procedure | Epidural analgesia initiated at the cervix diameter 3.0cm |
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| Epidural labor analgesia | Procedure | Epidural analgesia initiated at the cervix diameter 4.0cm |
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| Epidural labor analgesia | Procedure | Epidural analgesia initiated at the cervix diameter 5.0cm |
|
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| 10 min prior to analgesia, at the cervix <4.0 cm, cervix 4.0-10.0 cm, cervix >10.0cm second stage of labor, 15min after vaginal delivery |
| Duration of analgesia | 0 min after analgesia to 15min after the disappearance of sensory block |
| Maternal satisfaction with analgesia | 30 min after the vaginal delivery |
| Maternal oral temperature | 0, 15, 30, 60, 120, 240, 480min after analgesia |
| Use of oxytocin after analgesia | 30 min after vaginal delivery |
| Maximal oxytocin dose | 30 min after vaginal delivery |
| Low back pain at 3 months after vaginal delivery | Three months after vaginal delivery |
| Breastfeeding success at 6 weeks after vaginal delivery | Six weeks after successful delivery |
| Neonatal one-minute Apgar scale | 1 min after baby was born |
| Neonatal five-minute Apgar scale | Five min after baby was born |
| Umbilical-cord gases analysis | 0 min after baby was born |
| Neonatal sepsis evaluation | 30 min after baby was born |
| Neonatal antibiotic treatment | 1 week after baby was born |
| Incidence of maternal side effects | 1 week after successful vaginal delivery |
| 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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