Ten-year Practice of Labor Pain Control in China

Labor Pain Clinical Trial

— POPIC  

Official title:

A Ten-year Practice of Labor Pain Control in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00776581
• Other study ID #: NMU-FY2008-MZ013
• Secondary ID: NJFY081005
• Status: Completed
• Phase: N/A
• First received: October 20, 2008
• Last updated: September 17, 2009
• Start date: January 2009
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40000
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Labor Pain

Intervention

Procedure:
• CSEA with PCA
Records regarding combined spinal-epidural analgesia with patient-controlled pump
• CSEA with IBI
Records regarding combined spinal-epidural analgesia with intermittent bolus injection
• EA with PCA
Records regarding epidural analgesia with patient-controlled pump
• EA with IBI
Records regarding epidural analgesia with intermittent bolus injection

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of cesarean delivery		Analgesia initiation to successful vaginal delivery	Yes
Secondary	Rate of instrument-assisted delivery		Analgesia initiation to successful vaginal delivery	Yes
Secondary	Indications of cesarean delivery		Analgesia initiation to cesarean section	Yes
Secondary	Maternal Visual Analog Scale (VAS) rating of pain		Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to vaginal delivery	Yes
Secondary	Duration of analgesia		Initiation of analgesia to the disappearance of sensory block	Yes
Secondary	Maternal satisfaction with analgesia		At the end of the vaginal delivery	No
Secondary	Maternal oral temperature		Analgesia initiation to successful vaginal delivery	Yes
Secondary	Use of oxytocin after analgesia		After analgesia to vaginal delivery	Yes
Secondary	Low back pain at 3 months after vaginal delivery		At the third month after vaginal delivery	Yes
Secondary	Breastfeeding success at 6 weeks after vaginal delivery		At the sixth week after successful delivery	Yes
Secondary	Neonatal one-minute Apgar scale		At the first minute of baby was born	Yes
Secondary	Neonatal five-minute Apgar scale		At the fifth minute of baby was born	Yes
Secondary	Incidence of maternal side effects		Analgesia initiation to successful vaginal delivery	Yes
Secondary	Umbilical-cord gases analysis		At the time baby was born	Yes