Back to resultsLabor Analgesia in the Latent Phrase (LALP)
Primary Purpose
Labor Pain
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Active phrase epidural analgesia
Latent phrase epidural analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain focused on measuring Epidural analgesia, Latent analgesia, Active analgesia, Labor delivery
Eligibility Criteria
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.
Sites / Locations
- Nanjing Maternal and Child Health Care Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
I
II
Arm Description
Active phrase analgesia
Latent phrase analgesia
Outcomes
Primary Outcome Measures
Rate of Cesarean delivery
Secondary Outcome Measures
Time of latent phrase
Time of labor
Overall feeling of satisfaction of analgesia
Side effects
VAS pain intensity
Instrumental delivery
Oxytocin infusion rate
Neonatal Apgar scores
Umbilical gas measurement
Maternal oral temperature
Maternal corticosteroids
Full Information
NCT ID
NCT00647725
First Posted
March 28, 2008
Last Updated
September 30, 2009
Sponsor
Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT00647725
Brief Title
Labor Analgesia in the Latent Phrase
Acronym
LALP
Official Title
Labor Analgesia in the Latent Phrase of the First-stage of Spontaneous Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nanjing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Epidural analgesia, Latent analgesia, Active analgesia, Labor delivery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Active Comparator
Arm Description
Active phrase analgesia
Arm Title
II
Arm Type
Active Comparator
Arm Description
Latent phrase analgesia
Intervention Type
Procedure
Intervention Name(s)
Active phrase epidural analgesia
Intervention Description
Continuous epidural analgesia with sufentanil plus ropivacaine
Intervention Type
Procedure
Intervention Name(s)
Latent phrase epidural analgesia
Intervention Description
Continuous epidural analgesia with sufentanil plus ropivacaine
Primary Outcome Measure Information:
Title
Rate of Cesarean delivery
Time Frame
The time of the end of the labor
Secondary Outcome Measure Information:
Title
Time of latent phrase
Time Frame
From the beginning of regular contraction of uterus to the diameter of cervix to 4cm
Title
Time of labor
Time Frame
From the beginning of regular contraction of uterus to the end of the labor
Title
Overall feeling of satisfaction of analgesia
Time Frame
From the beginning of regular contraction of uterus to the end of the labor
Title
Side effects
Time Frame
From the beginning of regular contraction of uterus to the end of the labor
Title
VAS pain intensity
Time Frame
From the intinition of analgesia to the cervical dilation >4cm
Title
Instrumental delivery
Time Frame
The end of the time of the labor
Title
Oxytocin infusion rate
Time Frame
During the whole period of laboring
Title
Neonatal Apgar scores
Time Frame
1st min, 5th min, 10th min and 20th min
Title
Umbilical gas measurement
Time Frame
After delivering of the fetus
Title
Maternal oral temperature
Time Frame
From the initiation of analgesia to the end of the labor
Title
Maternal corticosteroids
Time Frame
1h before analgesia; 0h of the analgesia; 5min,10min,30min,45min,1h,2h,3h and hourly till the end of the labor
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoFeng Shen, MD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing Maternal and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
19741492
Citation
Wang F, Shen X, Guo X, Peng Y, Gu X; Labor Analgesia Examining Group. Epidural analgesia in the latent phase of labor and the risk of cesarean delivery: a five-year randomized controlled trial. Anesthesiology. 2009 Oct;111(4):871-80. doi: 10.1097/ALN.0b013e3181b55e65.
Results Reference
result
Learn more about this trial
Labor Analgesia in the Latent Phrase
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