Epidural Analgesia in Different Cervix Diameter and the Rate of Cesarean Delivery

Study Overview
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Brief Summary
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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.

Official Title
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Epidural Labor Analgesia in Different Cervical Dilation Diameter and the Risk of Cesarean Delivery

Conditions
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Labor Pain

Intervention / Treatment
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* Procedure: Epidural labor analgesia
* Procedure: Epidural labor analgesia
* Procedure: Epidural labor analgesia
* Procedure: Epidural labor analgesia
* Procedure: Epidural labor analgesia
* Procedure: Epidural labor analgesia
* Procedure: Epidural labor analgesia
* Procedure: Epidural labor analgesia


Participation Criteria
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Eligibility Criteria
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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 Using or used in the past 14 days of the monoamine oxidase inhibitors Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics; Subjects with a nonvertex presentation or scheduled induction of labor Cervical dilation was 5.0cm or greater before performing epidural puncture and catheterization. Diagnosed diabetes mellitus and pregnancy-induced hypertension Twin gestation and breech presentation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Epidural analgesia initiated at the cervix 0cm | Procedure: Epidural labor analgesia<br>* Epidural analgesia initiated at the onset of regular uterine contraction<br>* Other names: Peridural analgesia;|
| Active Comparator: 2<br>Epidural analgesia initiated at the cervix 0.5cm | Procedure: Epidural labor analgesia<br>* Epidural analgesia initiated at the cervix diameter 0.5cm<br>* Other names: Peridural analgesia;|
| Active Comparator: 3<br>Epidural analgesia initiated at the cervix 1.0cm | Procedure: Epidural labor analgesia<br>* Epidural analgesia initiated at the cervix diameter 1.0cm<br>* Other names: Peridural analgesia;|
| Active Comparator: 4<br>Epidural analgesia initiated at the cervix 1.5cm | Procedure: Epidural labor analgesia<br>* Epidural analgesia initiated at the cervix diameter 1.5cm<br>* Other names: Peridural analgesia;|
| Active Comparator: 5<br>Epidural analgesia initiated at the cervix 2.0cm | Procedure: Epidural labor analgesia<br>* Epidural analgesia initiated at the cervix diameter 2.0cm<br>* Other names: Peridural analgesia;|
| Active Comparator: 6<br>Epidural analgesia initiated at the cervix 3.0cm | Procedure: Epidural labor analgesia<br>* Epidural analgesia initiated at the cervix diameter 3.0cm<br>* Other names: Peridural analgesia;|
| Active Comparator: 7<br>Epidural analgesia initiated at the cervix 4.0cm | Procedure: Epidural labor analgesia<br>* Epidural analgesia initiated at the cervix diameter 4.0cm<br>* Other names: Peridural analgesia;|
| Active Comparator: 8<br>Epidural analgesia initiated at the cervix 5.0cm | Procedure: Epidural labor analgesia<br>* Epidural analgesia initiated at the cervix diameter 5.0cm<br>* Other names: Peridural analgesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cesarean delivery |  | 10 min after successful vaginal delivery | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural analgesia, Patient-controlled analgesia