Cesarean Rate in Parturients Without Neuraxial Analgesia

Study Overview
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Brief Summary
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Currently, it is certain that neuraxial analgesia in early stage of labor and delivery dose not increase the risk of Cesarean section. However, given ethical reasons, whether such a medical procedure could increase the Cesarean rate compared with those who did not received neuraxial analgesia or not is yet to be known. It is difficult to perform such a study in occidental countries because they have a higher rate of labor analgesia. On the contrary, the rate of labor analgesia in China is up to date only 1%, so it can be done easily. The investigators hypothesized that no neuraxial analgesia itself were a risk factor to Cesarean section. Therefore, the investigators design this study to compared the effect of neuraxial analgesia on the rate of Cesarean delivery with those who did not received neuraxial analgesia.

Official Title
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Comparison of the Cesarean Rate Between Parturients Who Received Neuraxial Analgesia and Those Who Did Not

Conditions
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Labor

Intervention / Treatment
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* Procedure: Neuraxial analgesia
* Procedure: Non-neuraxial analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 19yr, <=40 yr Height 140 - 170 cm Singleton pregnancy Uncomplicated pregnancy Chinese Exclusion Criteria: Multiple gestations Pregnancy-induced hypertension Diabetes mellitus Chronic pain Allergic to opioids and/or local anesthetics Failed to performing inter lumbar space catheterization Organic dysfunction Contraindications for neuraxial analgesia

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-neuraxial analgesia<br>Parturients will not receive neuraxial analgesia | Procedure: Non-neuraxial analgesia<br>* No neuraxial analgesia will be given to those who will not want to an analgesia<br>|
| Active Comparator: Neuraxial analgesia<br>Parturients will receive neuraxial analgesia | Procedure: Neuraxial analgesia<br>* Neuraxial analgesia will be given at any time if the parturient requested analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean rate | Rate of Cesarean delivery in both neuraxial and non-neuraxial analgesia women | One day after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Instrumental delivery | The rate of instrument-assisted delivery in both neuraxial and non-neuraxial analgesia women | One day after birth | 
| VAS pain intensity | Labor pain intensity assessed using visual analog scale (VAS) | At the begining of labor (0 min) | 
| VAS pain intensity | Labor pain intensity assessed using visual analog scale (VAS) | At the cervix 10 cm (This time may be subjected to change in different patients) | 
| VAS pain intensity | Labor pain intensity assessed using visual analog scale (VAS) | 2h after cervix 10 cm | 
| Time of successful labor | Labor duration in both neuraxial and non-neuraxial analgesia women | From the initial of labor (0 min) to completion of delivery (this is changable individually) | 
| Time of the first stage of labor | Duration of the first stage of labor | From initial of the labor to the cervix reached to 10 cm (Different in different patients) | 
| Time of second stage of labor | Duration of the second stage of labor | From the cervix at 10 cm to successful delivery of the baby (this is changable individually) | 
| Overall feeling of satisfaction of the labor | Satisfaction assessed using a visual analog scale (VAS) at the end of the labor delivery | At the end of successful baby delivery (it is changable individually) | 
| Side effects | Side effects recorded from the labor initiation to successful delivery | From the initial of labor (0 min) to the end of the labor (is is changable individually) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural analgesia, Latent analgesia, Active analgesia, Cesarean section