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

This study has been completed.
Sponsor:
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00677274
First received: May 12, 2008
Last updated: February 11, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention
Labor Pain
Procedure: Epidural labor analgesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Epidural Labor Analgesia in Different Cervical Dilation Diameter and the Risk of Cesarean Delivery

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Rate of cesarean delivery [ Time Frame: 10 min after successful vaginal delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of instrument-assisted delivery [ Time Frame: 10 min after successful vaginal delivery ] [ Designated as safety issue: Yes ]
  • Indications of cesarean delivery [ Time Frame: 10 min after cesarean section ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Duration of analgesia [ Time Frame: 0 min after analgesia to 15min after the disappearance of sensory block ] [ Designated as safety issue: Yes ]
  • Maternal satisfaction with analgesia [ Time Frame: 30 min after the vaginal delivery ] [ Designated as safety issue: No ]
  • Maternal oral temperature [ Time Frame: 0, 15, 30, 60, 120, 240, 480min after analgesia ] [ Designated as safety issue: Yes ]
  • Use of oxytocin after analgesia [ Time Frame: 30 min after vaginal delivery ] [ Designated as safety issue: Yes ]
  • Maximal oxytocin dose [ Time Frame: 30 min after vaginal delivery ] [ Designated as safety issue: No ]
  • Low back pain at 3 months after vaginal delivery [ Time Frame: Three months after vaginal delivery ] [ Designated as safety issue: Yes ]
  • Breastfeeding success at 6 weeks after vaginal delivery [ Time Frame: Six weeks after successful delivery ] [ Designated as safety issue: Yes ]
  • Neonatal one-minute Apgar scale [ Time Frame: 1 min after baby was born ] [ Designated as safety issue: Yes ]
  • Neonatal five-minute Apgar scale [ Time Frame: Five min after baby was born ] [ Designated as safety issue: Yes ]
  • Umbilical-cord gases analysis [ Time Frame: 0 min after baby was born ] [ Designated as safety issue: Yes ]
  • Neonatal sepsis evaluation [ Time Frame: 30 min after baby was born ] [ Designated as safety issue: Yes ]
  • Neonatal antibiotic treatment [ Time Frame: 1 week after baby was born ] [ Designated as safety issue: Yes ]
  • Incidence of maternal side effects [ Time Frame: 1 week after successful vaginal delivery ] [ Designated as safety issue: Yes ]

Enrollment: 780
Study Start Date: May 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Epidural analgesia initiated at the cervix 0cm
Procedure: Epidural labor analgesia
Epidural analgesia initiated at the onset of regular uterine contraction
Other Name: Peridural analgesia
Active Comparator: 2
Epidural analgesia initiated at the cervix 0.5cm
Procedure: Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 0.5cm
Other Name: Peridural analgesia
Active Comparator: 3
Epidural analgesia initiated at the cervix 1.0cm
Procedure: Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 1.0cm
Other Name: Peridural analgesia
Active Comparator: 4
Epidural analgesia initiated at the cervix 1.5cm
Procedure: Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 1.5cm
Other Name: Peridural analgesia
Active Comparator: 5
Epidural analgesia initiated at the cervix 2.0cm
Procedure: Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 2.0cm
Other Name: Peridural analgesia
Active Comparator: 6
Epidural analgesia initiated at the cervix 3.0cm
Procedure: Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 3.0cm
Other Name: Peridural analgesia
Active Comparator: 7
Epidural analgesia initiated at the cervix 4.0cm
Procedure: Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 4.0cm
Other Name: Peridural analgesia
Active Comparator: 8
Epidural analgesia initiated at the cervix 5.0cm
Procedure: Epidural labor analgesia
Epidural analgesia initiated at the cervix diameter 5.0cm
Other Name: Peridural analgesia

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Nulliparous women
  2. > 18 years and < 45 years
  3. Spontaneous labor
  4. Analgesia request

Exclusion Criteria:

  1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
  2. Participants younger than 18 years or older than 45 years
  3. Those who were not willing to or could not finish the whole study at any time
  4. Using or used in the past 14 days of the monoamine oxidase inhibitors
  5. Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics;
  6. Subjects with a nonvertex presentation or scheduled induction of labor
  7. Cervical dilation was 5.0cm or greater before performing epidural puncture and catheterization.
  8. Diagnosed diabetes mellitus and pregnancy-induced hypertension
  9. Twin gestation and breech presentation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677274

Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
HRSA/Maternal and Child Health Bureau
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
  More Information

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00677274     History of Changes
Other Study ID Numbers: NJFY-02028M03, NSR02970
Study First Received: May 12, 2008
Last Updated: February 11, 2009
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Epidural analgesia
Patient-controlled analgesia

Additional relevant MeSH terms:
Labor Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014