Epidural Analgesia in Different Cervix Diameter and the Rate of Cesarean Delivery (EACDRCD)
February 11, 2009 updated by: Nanjing Medical University
Epidural Labor Analgesia in Different Cervical Dilation Diameter and the Risk 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
780
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210004
- Nanjing Maternal and Child Health Care Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Epidural analgesia initiated at the cervix 0cm
|
Epidural analgesia initiated at the onset of regular uterine contraction
Other Names:
Epidural analgesia initiated at the cervix diameter 0.5cm
Other Names:
Epidural analgesia initiated at the cervix diameter 1.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 1.5cm
Other Names:
Epidural analgesia initiated at the cervix diameter 2.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 3.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 4.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 5.0cm
Other Names:
|
|
Active Comparator: 2
Epidural analgesia initiated at the cervix 0.5cm
|
Epidural analgesia initiated at the onset of regular uterine contraction
Other Names:
Epidural analgesia initiated at the cervix diameter 0.5cm
Other Names:
Epidural analgesia initiated at the cervix diameter 1.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 1.5cm
Other Names:
Epidural analgesia initiated at the cervix diameter 2.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 3.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 4.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 5.0cm
Other Names:
|
|
Active Comparator: 3
Epidural analgesia initiated at the cervix 1.0cm
|
Epidural analgesia initiated at the onset of regular uterine contraction
Other Names:
Epidural analgesia initiated at the cervix diameter 0.5cm
Other Names:
Epidural analgesia initiated at the cervix diameter 1.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 1.5cm
Other Names:
Epidural analgesia initiated at the cervix diameter 2.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 3.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 4.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 5.0cm
Other Names:
|
|
Active Comparator: 4
Epidural analgesia initiated at the cervix 1.5cm
|
Epidural analgesia initiated at the onset of regular uterine contraction
Other Names:
Epidural analgesia initiated at the cervix diameter 0.5cm
Other Names:
Epidural analgesia initiated at the cervix diameter 1.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 1.5cm
Other Names:
Epidural analgesia initiated at the cervix diameter 2.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 3.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 4.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 5.0cm
Other Names:
|
|
Active Comparator: 5
Epidural analgesia initiated at the cervix 2.0cm
|
Epidural analgesia initiated at the onset of regular uterine contraction
Other Names:
Epidural analgesia initiated at the cervix diameter 0.5cm
Other Names:
Epidural analgesia initiated at the cervix diameter 1.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 1.5cm
Other Names:
Epidural analgesia initiated at the cervix diameter 2.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 3.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 4.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 5.0cm
Other Names:
|
|
Active Comparator: 6
Epidural analgesia initiated at the cervix 3.0cm
|
Epidural analgesia initiated at the onset of regular uterine contraction
Other Names:
Epidural analgesia initiated at the cervix diameter 0.5cm
Other Names:
Epidural analgesia initiated at the cervix diameter 1.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 1.5cm
Other Names:
Epidural analgesia initiated at the cervix diameter 2.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 3.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 4.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 5.0cm
Other Names:
|
|
Active Comparator: 7
Epidural analgesia initiated at the cervix 4.0cm
|
Epidural analgesia initiated at the onset of regular uterine contraction
Other Names:
Epidural analgesia initiated at the cervix diameter 0.5cm
Other Names:
Epidural analgesia initiated at the cervix diameter 1.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 1.5cm
Other Names:
Epidural analgesia initiated at the cervix diameter 2.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 3.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 4.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 5.0cm
Other Names:
|
|
Active Comparator: 8
Epidural analgesia initiated at the cervix 5.0cm
|
Epidural analgesia initiated at the onset of regular uterine contraction
Other Names:
Epidural analgesia initiated at the cervix diameter 0.5cm
Other Names:
Epidural analgesia initiated at the cervix diameter 1.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 1.5cm
Other Names:
Epidural analgesia initiated at the cervix diameter 2.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 3.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 4.0cm
Other Names:
Epidural analgesia initiated at the cervix diameter 5.0cm
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of cesarean delivery
Time Frame: 10 min after successful vaginal delivery
|
10 min after successful vaginal delivery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Low back pain at 3 months after vaginal delivery
Time Frame: Three months after vaginal delivery
|
Three months after vaginal delivery
|
|
Maximal oxytocin dose
Time Frame: 30 min after vaginal delivery
|
30 min after vaginal delivery
|
|
Breastfeeding success at 6 weeks after vaginal delivery
Time Frame: Six weeks after successful delivery
|
Six weeks after successful delivery
|
|
Maternal satisfaction with analgesia
Time Frame: 30 min after the vaginal delivery
|
30 min after the vaginal delivery
|
|
Rate of instrument-assisted delivery
Time Frame: 10 min after successful vaginal delivery
|
10 min after successful vaginal delivery
|
|
Indications of cesarean delivery
Time Frame: 10 min after cesarean section
|
10 min after cesarean section
|
|
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
|
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
|
|
Duration of analgesia
Time Frame: 0 min after analgesia to 15min after the disappearance of sensory block
|
0 min after analgesia to 15min after the disappearance of sensory block
|
|
Maternal oral temperature
Time Frame: 0, 15, 30, 60, 120, 240, 480min after analgesia
|
0, 15, 30, 60, 120, 240, 480min after analgesia
|
|
Use of oxytocin after analgesia
Time Frame: 30 min after vaginal delivery
|
30 min after vaginal delivery
|
|
Neonatal one-minute Apgar scale
Time Frame: 1 min after baby was born
|
1 min after baby was born
|
|
Neonatal five-minute Apgar scale
Time Frame: Five min after baby was born
|
Five min after baby was born
|
|
Umbilical-cord gases analysis
Time Frame: 0 min after baby was born
|
0 min after baby was born
|
|
Neonatal sepsis evaluation
Time Frame: 30 min after baby was born
|
30 min after baby was born
|
|
Neonatal antibiotic treatment
Time Frame: 1 week after baby was born
|
1 week after baby was born
|
|
Incidence of maternal side effects
Time Frame: 1 week after successful vaginal delivery
|
1 week after successful vaginal delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
May 12, 2008
First Submitted That Met QC Criteria
May 12, 2008
First Posted (Estimate)
May 14, 2008
Study Record Updates
Last Update Posted (Estimate)
February 12, 2009
Last Update Submitted That Met QC Criteria
February 11, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NJFY-02028M03
- NSR02970
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.