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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
History of Changes
  Purpose

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 Intervention
Labor Pain
 Procedure: CSEA with PCA
Procedure: CSEA with IBI
Procedure: EA with PCA
Procedure: EA with IBI

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Ten-year Practice of Labor Pain Control in China

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Rate of cesarean delivery [ Time Frame: Analgesia initiation to successful vaginal delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40000
Study Start Date: January 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776581

Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Chair: XiaoFeng Shen, MD Nanjing Medical University
  More Information

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00776581     History of Changes
Other Study ID Numbers: NMU-FY2008-MZ013, NJFY081005
Study First Received: October 20, 2008
Last Updated: September 17, 2009
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Combined spinal-epidural analgesia
Patient-controlled analgesia
Epidural analgesia

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013