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Labor Analgesia in the Latent Phrase (LALP)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00647725
First received: March 28, 2008
Last updated: September 30, 2009
Last verified: September 2009
History of Changes

March 28, 2008
September 30, 2009
January 2003
December 2007   (final data collection date for primary outcome measure)
Rate of Cesarean delivery [ Time Frame: The time of the end of the labor ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00647725 on ClinicalTrials.gov Archive Site
  • Time of latent phrase [ Time Frame: From the beginning of regular contraction of uterus to the diameter of cervix to 4cm ] [ Designated as safety issue: Yes ]
  • Time of labor [ Time Frame: From the beginning of regular contraction of uterus to the end of the labor ] [ Designated as safety issue: Yes ]
  • Overall feeling of satisfaction of analgesia [ Time Frame: From the beginning of regular contraction of uterus to the end of the labor ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: From the beginning of regular contraction of uterus to the end of the labor ] [ Designated as safety issue: Yes ]
  • VAS pain intensity [ Time Frame: From the intinition of analgesia to the cervical dilation >4cm ] [ Designated as safety issue: Yes ]
  • Instrumental delivery [ Time Frame: The end of the time of the labor ] [ Designated as safety issue: Yes ]
  • Oxytocin infusion rate [ Time Frame: During the whole period of laboring ] [ Designated as safety issue: Yes ]
  • Neonatal Apgar scores [ Time Frame: 1st min, 5th min, 10th min and 20th min ] [ Designated as safety issue: Yes ]
  • Umbilical gas measurement [ Time Frame: After delivering of the fetus ] [ Designated as safety issue: Yes ]
  • Maternal oral temperature [ Time Frame: From the initiation of analgesia to the end of the labor ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Labor Analgesia in the Latent Phrase
Labor Analgesia in the Latent Phrase of the First-stage of Spontaneous Delivery

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Labor Pain
  • Procedure: Active phrase epidural analgesia
    Continuous epidural analgesia with sufentanil plus ropivacaine
  • Procedure: Latent phrase epidural analgesia
    Continuous epidural analgesia with sufentanil plus ropivacaine
  • Active Comparator: I
    Active phrase analgesia
    Intervention: Procedure: Active phrase epidural analgesia
  • Active Comparator: II
    Latent phrase analgesia
    Intervention: Procedure: Latent phrase epidural analgesia
Wang F, Shen X, Guo X, Peng Y, Gu X; The Labor Analgesia Examining Group (LAEG). Epidural Analgesia in the Latent Phase of Labor and the Risk of Cesarean Delivery: A Five-year Randomized Controlled Trial. Anesthesiology. 2009 Sep 7; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15000
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00647725
NMU-69714-14XS, MCH03552
Yes
XiaoFeng Shen, Nanjing Medical University
Nanjing Medical University
Not Provided
Study Director: XiaoFeng Shen, MD Nanjing Medical University
Nanjing Medical University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP