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

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ClinicalTrials.gov Identifier: NCT00776581
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : September 18, 2009
Sponsor:
Information provided by:
Nanjing Medical University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Labor Pain Procedure: CSEA with PCA Procedure: CSEA with IBI Procedure: EA with PCA Procedure: EA with IBI

Study Design
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Study Type : Observational
Actual Enrollment : 40000 participants
Time Perspective: Retrospective
Official Title: A Ten-year Practice of Labor Pain Control in China
Study Start Date : January 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
1
Records regarding combined spinal-epidural analgesia (CSEA) with patient-controlled analgesia (PCA) pump
 Procedure: CSEA with PCA
Records regarding combined spinal-epidural analgesia with patient-controlled pump
2
Records regarding combined spinal-epidural analgesia with intermittent bolus injection (IBI)
 Procedure: CSEA with IBI
Records regarding combined spinal-epidural analgesia with intermittent bolus injection
3
Records regarding epidural analgesia (EA) with patient-controlled pump
 Procedure: EA with PCA
Records regarding epidural analgesia with patient-controlled pump
4
Records regarding epidural analgesia with intermittent bolus injection
 Procedure: EA with IBI
Records regarding epidural analgesia with intermittent bolus injection


Outcome Measures
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Primary Outcome Measures :
  1. Rate of cesarean delivery [ Time Frame: Analgesia initiation to successful vaginal delivery ]

Secondary Outcome Measures :
  1. Rate of instrument-assisted delivery [ Time Frame: Analgesia initiation to successful vaginal delivery ]
  2. Indications of cesarean delivery [ Time Frame: Analgesia initiation to cesarean section ]
  3. 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 ]
  4. Duration of analgesia [ Time Frame: Initiation of analgesia to the disappearance of sensory block ]
  5. Maternal satisfaction with analgesia [ Time Frame: At the end of the vaginal delivery ]
  6. Maternal oral temperature [ Time Frame: Analgesia initiation to successful vaginal delivery ]
  7. Use of oxytocin after analgesia [ Time Frame: After analgesia to vaginal delivery ]
  8. Low back pain at 3 months after vaginal delivery [ Time Frame: At the third month after vaginal delivery ]
  9. Breastfeeding success at 6 weeks after vaginal delivery [ Time Frame: At the sixth week after successful delivery ]
  10. Neonatal one-minute Apgar scale [ Time Frame: At the first minute of baby was born ]
  11. Neonatal five-minute Apgar scale [ Time Frame: At the fifth minute of baby was born ]
  12. Incidence of maternal side effects [ Time Frame: Analgesia initiation to successful vaginal delivery ]
  13. Umbilical-cord gases analysis [ Time Frame: At the time baby was born ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All parturients delivered in the investigator's institution since from January 1999 to December 2008
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776581


Locations
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China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
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Study Chair: XiaoFeng Shen, MD Nanjing Medical University
More Information
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Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00776581    
Other Study ID Numbers: NMU-FY2008-MZ013
NJFY081005
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009
Keywords provided by Nanjing Medical University:
Combined spinal-epidural analgesia
Patient-controlled analgesia
Epidural analgesia
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations