Clinical trial NCT00776581: Ten-year Practice of Labor Pain Control in China
Official title: A Ten-year Practice of Labor Pain Control in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Pain
Keywords: Combined spinal-epidural analgesia
Patient-controlled analgesia
Epidural analgesia
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2008-10-21
Enrollment: 40000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All parturients delivered in the investigator's institution since from January 1999 to December 2008

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.


Eligibility 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

Primary outcomes:
measure: Rate of cesarean delivery
timeFrame: Analgesia initiation to successful vaginal delivery
Secondary outcomes:
measure: Rate of instrument-assisted delivery
timeFrame: Analgesia initiation to successful vaginal delivery
measure: Indications of cesarean delivery
timeFrame: Analgesia initiation to cesarean section
measure: Maternal Visual Analog Scale (VAS) rating of pain
timeFrame: Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to vaginal delivery
measure: Duration of analgesia
timeFrame: Initiation of analgesia to the disappearance of sensory block
measure: Maternal satisfaction with analgesia
timeFrame: At the end of the vaginal delivery
measure: Maternal oral temperature
timeFrame: Analgesia initiation to successful vaginal delivery
measure: Use of oxytocin after analgesia
timeFrame: After analgesia to vaginal delivery
measure: Low back pain at 3 months after vaginal delivery
timeFrame: At the third month after vaginal delivery
measure: Breastfeeding success at 6 weeks after vaginal delivery
timeFrame: At the sixth week after successful delivery
measure: Neonatal one-minute Apgar scale
timeFrame: At the first minute of baby was born
measure: Neonatal five-minute Apgar scale
timeFrame: At the fifth minute of baby was born
measure: Incidence of maternal side effects
timeFrame: Analgesia initiation to successful vaginal delivery
measure: Umbilical-cord gases analysis
timeFrame: At the time baby was born
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_CHAIR
References: