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

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Procedure: CSEA with PCA; Procedure: CSEA with IBI; Procedure: EA with PCA; Procedure: EA with IBI

• Study Type: Observational
• Enrollment (Actual): 40000

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210004
      • Nanjing Maternal and Child Health Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of cesarean delivery	Analgesia initiation to successful vaginal delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
Maternal Visual Analog Scale (VAS) rating of pain	Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to vaginal delivery
Breastfeeding success at 6 weeks after vaginal delivery	At the sixth week after successful delivery
Neonatal one-minute Apgar scale	At the first minute of baby was born
Neonatal five-minute Apgar scale	At the fifth minute of baby was born
Low back pain at 3 months after vaginal delivery	At the third month after vaginal delivery
Rate of instrument-assisted delivery	Analgesia initiation to successful vaginal delivery
Indications of cesarean delivery	Analgesia initiation to cesarean section
Duration of analgesia	Initiation of analgesia to the disappearance of sensory block
Maternal satisfaction with analgesia	At the end of the vaginal delivery
Maternal oral temperature	Analgesia initiation to successful vaginal delivery
Use of oxytocin after analgesia	After analgesia to vaginal delivery
Incidence of maternal side effects	Analgesia initiation to successful vaginal delivery
Umbilical-cord gases analysis	At the time baby was born

Collaborators and Investigators

• Sponsor: Nanjing Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: October 20, 2008
• First Submitted That Met QC Criteria: October 20, 2008
• First Posted (Estimate): October 21, 2008

Study Record Updates

• Last Update Posted (Estimate): September 18, 2009
• Last Update Submitted That Met QC Criteria: September 17, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Epidural analgesia; Patient-controlled analgesia; Combined spinal-epidural analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: NMU-FY2008-MZ013; NJFY081005