EACDRCD: Epidural Analgesia in Different Cervix Diameter and the Rate of Cesarean Delivery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1 Epidural analgesia initiated at the cervix 0cm |
Procedure: Epidural labor analgesia
Epidural analgesia initiated at the onset of regular uterine contraction
Other Names:
|
| Active Comparator: 2 Epidural analgesia initiated at the cervix 0.5cm |
Procedure: Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 0.5cm
Other Names:
|
| Active Comparator: 3 Epidural analgesia initiated at the cervix 1.0cm |
Procedure: Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 1.0cm
Other Names:
|
| Active Comparator: 4 Epidural analgesia initiated at the cervix 1.5cm |
Procedure: Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 1.5cm
Other Names:
|
| Active Comparator: 5 Epidural analgesia initiated at the cervix 2.0cm |
Procedure: Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 2.0cm
Other Names:
|
| Active Comparator: 6 Epidural analgesia initiated at the cervix 3.0cm |
Procedure: Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 3.0cm
Other Names:
|
| Active Comparator: 7 Epidural analgesia initiated at the cervix 4.0cm |
Procedure: Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 4.0cm
Other Names:
|
| Active Comparator: 8 Epidural analgesia initiated at the cervix 5.0cm |
Procedure: Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 5.0cm
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Rate of cesarean delivery [10 min after successful vaginal delivery]
Secondary Outcome Measures
- 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 [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Nulliparous women
-
18 years and < 45 years
-
Spontaneous labor
-
Analgesia request
Exclusion Criteria:
-
Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
-
Participants younger than 18 years or older than 45 years
-
Those who were not willing to or could not finish the whole study at any time
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Using or used in the past 14 days of the monoamine oxidase inhibitors
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Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics;
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Subjects with a nonvertex presentation or scheduled induction of labor
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Cervical dilation was 5.0cm or greater before performing epidural puncture and catheterization.
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Diagnosed diabetes mellitus and pregnancy-induced hypertension
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Twin gestation and breech presentation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nanjing Maternal and Child Health Care Hospital | Nanjing | Jiangsu | China | 210004 |
Sponsors and Collaborators
- Nanjing Medical University
- HRSA/Maternal and Child Health Bureau
Investigators
- Study Director: XiaoFeng Shen, MD, Nanjing Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NJFY-02028M03
- NSR02970