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

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Epidural labor analgesia
Epidural labor analgesia
Epidural labor analgesia
Epidural labor analgesia
Epidural labor analgesia
Epidural labor analgesia
Epidural labor analgesia
Epidural labor analgesia
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Epidural analgesia, Patient-controlled analgesia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanjing Maternal and Child Health Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

5

6

7

8

Arm Description

Epidural analgesia initiated at the cervix 0cm

Epidural analgesia initiated at the cervix 0.5cm

Epidural analgesia initiated at the cervix 1.0cm

Epidural analgesia initiated at the cervix 1.5cm

Epidural analgesia initiated at the cervix 2.0cm

Epidural analgesia initiated at the cervix 3.0cm

Epidural analgesia initiated at the cervix 4.0cm

Epidural analgesia initiated at the cervix 5.0cm

Outcomes

Primary Outcome Measures

Rate of cesarean delivery

Secondary Outcome Measures

Rate of instrument-assisted delivery
Indications of cesarean delivery
Maternal Visual Analog Scale (VAS) rating of pain
Duration of analgesia
Maternal satisfaction with analgesia
Maternal oral temperature
Use of oxytocin after analgesia
Maximal oxytocin dose
Low back pain at 3 months after vaginal delivery
Breastfeeding success at 6 weeks after vaginal delivery
Neonatal one-minute Apgar scale
Neonatal five-minute Apgar scale
Umbilical-cord gases analysis
Neonatal sepsis evaluation
Neonatal antibiotic treatment
Incidence of maternal side effects

Full Information

First Posted
May 12, 2008
Last Updated
February 11, 2009
Sponsor
Nanjing Medical University
Collaborators
HRSA/Maternal and Child Health Bureau
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1. Study Identification

Unique Protocol Identification Number
NCT00677274
Brief Title
Epidural Analgesia in Different Cervix Diameter and the Rate of Cesarean Delivery
Acronym
EACDRCD
Official Title
Epidural Labor Analgesia in Different Cervical Dilation Diameter and the Risk of Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing Medical University
Collaborators
HRSA/Maternal and Child Health Bureau

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Epidural analgesia, Patient-controlled analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
780 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Epidural analgesia initiated at the cervix 0cm
Arm Title
2
Arm Type
Active Comparator
Arm Description
Epidural analgesia initiated at the cervix 0.5cm
Arm Title
3
Arm Type
Active Comparator
Arm Description
Epidural analgesia initiated at the cervix 1.0cm
Arm Title
4
Arm Type
Active Comparator
Arm Description
Epidural analgesia initiated at the cervix 1.5cm
Arm Title
5
Arm Type
Active Comparator
Arm Description
Epidural analgesia initiated at the cervix 2.0cm
Arm Title
6
Arm Type
Active Comparator
Arm Description
Epidural analgesia initiated at the cervix 3.0cm
Arm Title
7
Arm Type
Active Comparator
Arm Description
Epidural analgesia initiated at the cervix 4.0cm
Arm Title
8
Arm Type
Active Comparator
Arm Description
Epidural analgesia initiated at the cervix 5.0cm
Intervention Type
Procedure
Intervention Name(s)
Epidural labor analgesia
Other Intervention Name(s)
Peridural analgesia
Intervention Description
Epidural analgesia initiated at the onset of regular uterine contraction
Intervention Type
Procedure
Intervention Name(s)
Epidural labor analgesia
Other Intervention Name(s)
Peridural analgesia
Intervention Description
Epidural analgesia initiated at the cervix diameter 0.5cm
Intervention Type
Procedure
Intervention Name(s)
Epidural labor analgesia
Other Intervention Name(s)
Peridural analgesia
Intervention Description
Epidural analgesia initiated at the cervix diameter 1.0cm
Intervention Type
Procedure
Intervention Name(s)
Epidural labor analgesia
Other Intervention Name(s)
Peridural analgesia
Intervention Description
Epidural analgesia initiated at the cervix diameter 1.5cm
Intervention Type
Procedure
Intervention Name(s)
Epidural labor analgesia
Other Intervention Name(s)
Peridural analgesia
Intervention Description
Epidural analgesia initiated at the cervix diameter 2.0cm
Intervention Type
Procedure
Intervention Name(s)
Epidural labor analgesia
Other Intervention Name(s)
Peridural analgesia
Intervention Description
Epidural analgesia initiated at the cervix diameter 3.0cm
Intervention Type
Procedure
Intervention Name(s)
Epidural labor analgesia
Other Intervention Name(s)
Peridural analgesia
Intervention Description
Epidural analgesia initiated at the cervix diameter 4.0cm
Intervention Type
Procedure
Intervention Name(s)
Epidural labor analgesia
Other Intervention Name(s)
Peridural analgesia
Intervention Description
Epidural analgesia initiated at the cervix diameter 5.0cm
Primary Outcome Measure Information:
Title
Rate of cesarean delivery
Time Frame
10 min after successful vaginal delivery
Secondary Outcome Measure Information:
Title
Rate of instrument-assisted delivery
Time Frame
10 min after successful vaginal delivery
Title
Indications of cesarean delivery
Time Frame
10 min after cesarean section
Title
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
Title
Duration of analgesia
Time Frame
0 min after analgesia to 15min after the disappearance of sensory block
Title
Maternal satisfaction with analgesia
Time Frame
30 min after the vaginal delivery
Title
Maternal oral temperature
Time Frame
0, 15, 30, 60, 120, 240, 480min after analgesia
Title
Use of oxytocin after analgesia
Time Frame
30 min after vaginal delivery
Title
Maximal oxytocin dose
Time Frame
30 min after vaginal delivery
Title
Low back pain at 3 months after vaginal delivery
Time Frame
Three months after vaginal delivery
Title
Breastfeeding success at 6 weeks after vaginal delivery
Time Frame
Six weeks after successful delivery
Title
Neonatal one-minute Apgar scale
Time Frame
1 min after baby was born
Title
Neonatal five-minute Apgar scale
Time Frame
Five min after baby was born
Title
Umbilical-cord gases analysis
Time Frame
0 min after baby was born
Title
Neonatal sepsis evaluation
Time Frame
30 min after baby was born
Title
Neonatal antibiotic treatment
Time Frame
1 week after baby was born
Title
Incidence of maternal side effects
Time Frame
1 week after successful vaginal delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoFeng Shen, MD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing Maternal and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China

12. IPD Sharing Statement

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

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