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Completed

NCT Number: NCT00776581

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Chronic pain and psychiatric diseases records
  • Participants younger than 18 years or older than 45 years
  • Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics
  • Subjects with a nonvertex presentation or scheduled induction of labor
  • Diagnosed diabetes mellitus and pregnancy-induced hypertension
  • Twin gestation and breech presentation

Treatment and study plan

CSEA with PCA

Procedure

Records regarding combined spinal-epidural analgesia with patient-controlled pump

CSEA with IBI

Procedure

Records regarding combined spinal-epidural analgesia with intermittent bolus injection

EA with PCA

Procedure

Records regarding epidural analgesia with patient-controlled pump

EA with IBI

Procedure

Records regarding epidural analgesia with intermittent bolus injection

Primary outcomes

  1. Rate of cesarean delivery

    Time frame: Analgesia initiation to successful vaginal delivery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

A Ten-year Practice of Labor Pain Control in China

Acronym: POPIC

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 21, 2008
Registry last updated
Sep 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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