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Ten-year Practice of Labor Pain Control in China (POPIC)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00776581
First received: October 20, 2008
Last updated: September 17, 2009
Last verified: September 2009

October 20, 2008
September 17, 2009
January 2009
September 2009   (final data collection date for primary outcome measure)
Rate of cesarean delivery [ Time Frame: Analgesia initiation to successful vaginal delivery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00776581 on ClinicalTrials.gov Archive Site
  • Rate of instrument-assisted delivery [ Time Frame: Analgesia initiation to successful vaginal delivery ] [ Designated as safety issue: Yes ]
  • Indications of cesarean delivery [ Time Frame: Analgesia initiation to cesarean section ] [ Designated as safety issue: Yes ]
  • Maternal Visual Analog Scale (VAS) rating of pain [ Time Frame: Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to vaginal delivery ] [ Designated as safety issue: Yes ]
  • Duration of analgesia [ Time Frame: Initiation of analgesia to the disappearance of sensory block ] [ Designated as safety issue: Yes ]
  • Maternal satisfaction with analgesia [ Time Frame: At the end of the vaginal delivery ] [ Designated as safety issue: No ]
  • Maternal oral temperature [ Time Frame: Analgesia initiation to successful vaginal delivery ] [ Designated as safety issue: Yes ]
  • Use of oxytocin after analgesia [ Time Frame: After analgesia to vaginal delivery ] [ Designated as safety issue: Yes ]
  • Low back pain at 3 months after vaginal delivery [ Time Frame: At the third month after vaginal delivery ] [ Designated as safety issue: Yes ]
  • Breastfeeding success at 6 weeks after vaginal delivery [ Time Frame: At the sixth week after successful delivery ] [ Designated as safety issue: Yes ]
  • Neonatal one-minute Apgar scale [ Time Frame: At the first minute of baby was born ] [ Designated as safety issue: Yes ]
  • Neonatal five-minute Apgar scale [ Time Frame: At the fifth minute of baby was born ] [ Designated as safety issue: Yes ]
  • Incidence of maternal side effects [ Time Frame: Analgesia initiation to successful vaginal delivery ] [ Designated as safety issue: Yes ]
  • Umbilical-cord gases analysis [ Time Frame: At the time baby was born ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Ten-year Practice of Labor Pain Control in China
A Ten-year Practice of Labor Pain Control in China

Since 1999, labor pain control has being performed in China, and the initial time of analgesia is at the cervix >= 2 cm. Meanwhile, American Society of Obstetrics & Gynecology recommended that the labor analgesia with neuraxial block should be performed at the cervix >= 4 cm in 2002. After that, the threshold has been revised to at least >= 2 cm in 2006 by the Society. However, in China, the practice of labor analgesia with neuraxial block has being performed for over seven years. Up until now, the practice has being experienced during this ten-year period at the cervix around 1 cm. The investigators hypothesized that labor pain control in different stages had different characteristics and had different influence on patients short- and long-lasting outcomes. This study is mainly investigating different labor analgesia procedures in different stages since the initiation of the practice in 1999, and assessing their influence on the outcomes to display the trajectory of development of labor analgesia in China of which might fit to the the whole process of the study of labor analgesia throughout the world. All these were done by analyzing the data records since from January 1999 to December 2008.

Not Provided
Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

All parturients delivered in the investigator's institution since from January 1999 to December 2008

Labor Pain
  • Procedure: CSEA with PCA
    Records regarding combined spinal-epidural analgesia with patient-controlled pump
  • Procedure: CSEA with IBI
    Records regarding combined spinal-epidural analgesia with intermittent bolus injection
  • Procedure: EA with PCA
    Records regarding epidural analgesia with patient-controlled pump
  • Procedure: EA with IBI
    Records regarding epidural analgesia with intermittent bolus injection
  • 1
    Records regarding combined spinal-epidural analgesia (CSEA) with patient-controlled analgesia (PCA) pump
    Intervention: Procedure: CSEA with PCA
  • 2
    Records regarding combined spinal-epidural analgesia with intermittent bolus injection (IBI)
    Intervention: Procedure: CSEA with IBI
  • 3
    Records regarding epidural analgesia (EA) with patient-controlled pump
    Intervention: Procedure: EA with PCA
  • 4
    Records regarding epidural analgesia with intermittent bolus injection
    Intervention: Procedure: EA with IBI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40000
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Parturients used labor analgesia

Exclusion Criteria:

  • Following criteria were based on the records of information received from the ten-year practice screened by investigators:

    1. Chronic pain and psychiatric diseases records
    2. Participants younger than 18 years or older than 45 years
    3. Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics
    4. Subjects with a nonvertex presentation or scheduled induction of labor
    5. Diagnosed diabetes mellitus and pregnancy-induced hypertension
    6. Twin gestation and breech presentation
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00776581
NMU-FY2008-MZ013, NJFY081005
Yes
XiaoFeng Shen, Nanjing Medical University
Nanjing Medical University
Not Provided
Study Chair: 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