Labor Analgesia in the Latent Phrase

Study Overview
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Brief Summary
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Painless labor is an essential part in woman's health care. Labor analgesia in the active phrase is in popular use currently. However, parturients are still haunted by the labor delivery pain in the latent phrase up to 7-8 hours, especially for the nulliparas. Therefore, we hypothesized that labor analgesia in the latent phrase of the first delivery stage would provide superior health care for laboring women. In addition, such analgesia technique would not prolong the time of uterine dilation and labor delivering.

Official Title
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Labor Analgesia in the Latent Phrase of the First-stage of Spontaneous Delivery

Conditions
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Labor Pain

Intervention / Treatment
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* Procedure: Active phrase epidural analgesia
* Procedure: Latent phrase epidural analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nulliparas Required labor analgesia Chinese. Exclusion Criteria: Allergic to opioids and/or local anesthetics Failed to performing epidural catheterization Organic dysfunction Contraindications for epidural analgesia.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>Active phrase analgesia | Procedure: Active phrase epidural analgesia<br>* Continuous epidural analgesia with sufentanil plus ropivacaine<br>|
| Active Comparator: II<br>Latent phrase analgesia | Procedure: Latent phrase epidural analgesia<br>* Continuous epidural analgesia with sufentanil plus ropivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Cesarean delivery |  | The time of the end of the labor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of latent phrase |  | From the beginning of regular contraction of uterus to the diameter of cervix to 4cm | 
| Time of labor |  | From the beginning of regular contraction of uterus to the end of the labor | 
| Overall feeling of satisfaction of analgesia |  | From the beginning of regular contraction of uterus to the end of the labor | 
| Side effects |  | From the beginning of regular contraction of uterus to the end of the labor | 
| VAS pain intensity |  | From the intinition of analgesia to the cervical dilation >4cm | 
| Instrumental delivery |  | The end of the time of the labor | 
| Oxytocin infusion rate |  | During the whole period of laboring | 
| Neonatal Apgar scores |  | 1st min, 5th min, 10th min and 20th min | 
| Umbilical gas measurement |  | After delivering of the fetus | 
| Maternal oral temperature |  | From the initiation of analgesia to the end of the labor | 
| Maternal corticosteroids |  | 1h before analgesia; 0h of the analgesia; 5min,10min,30min,45min,1h,2h,3h and hourly till the end of the labor | 

 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, Labor delivery