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Completed

NCT Number: NCT00677274

Epidural Analgesia in Different Cervix Diameter and the Rate of Cesarean Delivery

Epidural analgesia in the early stage of labor at cervix < 4.0cm was considered as a risk period for increasing the rate of cesarean delivery. The more recent studies and the investigators' previous data indicated epidural analgesia can be performed as early as the cervical dilation approximately 2.0cm. The investigators hypothesized that different cervix diameter had different rate of cesarean delivery. This trial would investigate the correlation amongst different cervical dilation and the risk of cesarean section in nulliparous women at term.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

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

  • Nulliparous women
  • > 18 years and < 45 years
  • Spontaneous labor
  • Analgesia request

Exclusion criteria

  • Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
  • Participants younger than 18 years or older than 45 years
  • Those who were not willing to or could not finish the whole study at any time
  • Using or used in the past 14 days of the monoamine oxidase inhibitors
  • 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
  • Cervical dilation was 5.0cm or greater before performing epidural puncture and catheterization.
  • Diagnosed diabetes mellitus and pregnancy-induced hypertension
  • Twin gestation and breech presentation.

Treatment and study plan

Epidural labor analgesia

Procedure

Epidural analgesia initiated at the onset of regular uterine contraction

Other names: Peridural analgesia

Primary outcomes

  1. Rate of cesarean delivery

    Time frame: 10 min after successful vaginal delivery

Secondary outcomes

  1. Rate of instrument-assisted delivery

    Time frame: 10 min after successful vaginal delivery

  2. Indications of cesarean delivery

    Time frame: 10 min after cesarean section

  3. Maternal Visual Analog Scale (VAS) rating of pain

    Time frame: 10 min prior to analgesia, at the cervix <4.0 cm, cervix 4.0-10.0 cm, cervix >10.0cm second stage of labor, 15min after vaginal delivery

  4. Duration of analgesia

    Time frame: 0 min after analgesia to 15min after the disappearance of sensory block

  5. Maternal satisfaction with analgesia

    Time frame: 30 min after the vaginal delivery

  6. Maternal oral temperature

    Time frame: 0, 15, 30, 60, 120, 240, 480min after analgesia

  7. Use of oxytocin after analgesia

    Time frame: 30 min after vaginal delivery

  8. Maximal oxytocin dose

    Time frame: 30 min after vaginal delivery

  9. Low back pain at 3 months after vaginal delivery

    Time frame: Three months after vaginal delivery

  10. Breastfeeding success at 6 weeks after vaginal delivery

    Time frame: Six weeks after successful delivery

  11. Neonatal one-minute Apgar scale

    Time frame: 1 min after baby was born

  12. Neonatal five-minute Apgar scale

    Time frame: Five min after baby was born

  13. Umbilical-cord gases analysis

    Time frame: 0 min after baby was born

  14. Neonatal sepsis evaluation

    Time frame: 30 min after baby was born

  15. Neonatal antibiotic treatment

    Time frame: 1 week after baby was born

  16. Incidence of maternal side effects

    Time frame: 1 week after successful vaginal delivery

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Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • HRSA/Maternal and Child Health Bureau

Registry information

Official study title

Epidural Labor Analgesia in Different Cervical Dilation Diameter and the Risk of Cesarean Delivery

Acronym: EACDRCD

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 14, 2008
Registry last updated
Feb 12, 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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