Back to resultsDoula Combined Latent Phrase Epidural Analgesia in Primiparous Women (DCLEAP)
Primary Purpose
Labor Pain
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Doula combined analgesia
Analgesia without doula
Sponsored by
About this trial
This is an interventional prevention trial for Labor Pain focused on measuring Doula, Patient-controlled epidural analgesia, Neuraxial analgesia, Labor analgesia
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 4.0 cm or greater before performing epidural puncture and catheterization
Sites / Locations
- Nanjing Maternal and Child Health Care Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
1
2
Arm Description
Doula combined epidural analgesia in the latent phase of first stage of labor
Epidural analgesia in the latent phase of the first stage of labor without doula accompany
Outcomes
Primary Outcome Measures
Rate of cesarean delivery
Secondary Outcome Measures
Rate of instrumental delivery
Indications of cesarean delivery
Maternal Visual Analog Scale (VAS) rating of pain
Incidence of side effects
Low back pain at 3 months after vaginal delivery
Maternal oral temperature
Use of oxytocin after analgesia
Maximal oxytocin dose
Duration of analgesia
Breastfeeding success at 6 weeks after vaginal delivery
Maternal satisfaction with analgesia
Neonatal one-minute Apgar scale
Neonatal five-minute Apgar scale
Umbilical-cord gases analysis
Neonatal sepsis evaluation
Neonatal antibiotic treatment
Full Information
NCT ID
NCT00664118
First Posted
April 18, 2008
Last Updated
May 26, 2009
Sponsor
Nanjing Medical University
Collaborators
HRSA/Maternal and Child Health Bureau
1. Study Identification
Unique Protocol Identification Number
NCT00664118
Brief Title
Doula Combined Latent Phrase Epidural Analgesia in Primiparous Women
Acronym
DCLEAP
Official Title
In Combination of Doula and Epidural Analgesia in the Latent Phrase of Labor in Primiparous Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (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
Accumulating evidence indicated that neuraxial analgesia in the latent phase of the first stage of labor would be an effective and safe health care procedure for nulliparas. Doulas, women with labor experience trained for parturients, is a new way to alleviate the psychological stress from the laboring pain. Previous data in our study showed that doula accompany is a good method in shortening the progress of labor used in the active phrase of the first stage of labor, and decreasing the rate of cesarean delivery. Investigators hypothesized that doula combined neuraxial (epidural) analgesia in the latent phrase would be a superior means for effective pain relief, decreased rate of cesarean section, and shortened duration of labor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Doula, Patient-controlled epidural analgesia, Neuraxial analgesia, Labor analgesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Doula combined epidural analgesia in the latent phase of first stage of labor
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Epidural analgesia in the latent phase of the first stage of labor without doula accompany
Intervention Type
Procedure
Intervention Name(s)
Doula combined analgesia
Intervention Description
Doula combined epidural analgesia in the latent phase of first stage of labor in primiparas
Intervention Type
Procedure
Intervention Name(s)
Analgesia without doula
Intervention Description
Epidural analgesia in the latent phase of first stage of labor without doula accompany in primiparas
Primary Outcome Measure Information:
Title
Rate of cesarean delivery
Time Frame
Analgesia initiation (0 h) to completion of vaginal delivery (4-7 h)
Secondary Outcome Measure Information:
Title
Rate of instrumental delivery
Time Frame
Analgesia initiation (0 h) to successful vaginal delivery (4-7 h)
Title
Indications of cesarean delivery
Time Frame
Analgesia initiation (0 h) to cesarean section (4-7 h)
Title
Maternal Visual Analog Scale (VAS) rating of pain
Time Frame
15 min prior to analgesia, 0-3 h of the latent phrase, 2-3 h of the active phrase, 1-2 h of the second stage of labor, 15 min posterior to delivery
Title
Incidence of side effects
Time Frame
The whole period of the analgesia to successful vaginal delivery
Title
Low back pain at 3 months after vaginal delivery
Time Frame
Three months after vaginal delivery
Title
Maternal oral temperature
Time Frame
The whole period of the analgesia to successful vaginal delivery
Title
Use of oxytocin after analgesia
Time Frame
During the whole period of the analgesia
Title
Maximal oxytocin dose
Time Frame
30 min after vaginal delivery
Title
Duration of analgesia
Time Frame
Initiation of analgesia (0h) to the disappearance of sensory block (4-8h)
Title
Breastfeeding success at 6 weeks after vaginal delivery
Time Frame
Six weeks after successful delivery
Title
Maternal satisfaction with analgesia
Time Frame
30 min after the vaginal delivery
Title
Neonatal one-minute Apgar scale
Time Frame
One minute after baby was born
Title
Neonatal five-minute Apgar scale
Time Frame
Five minutes after baby was born
Title
Umbilical-cord gases analysis
Time Frame
Immediately after baby was born
Title
Neonatal sepsis evaluation
Time Frame
5 min after the baby was born
Title
Neonatal antibiotic treatment
Time Frame
5 min after the baby was born
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 4.0 cm or greater before performing epidural puncture and catheterization
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
Learn more about this trial
Doula Combined Latent Phrase Epidural Analgesia in Primiparous Women
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