Back to resultsEffect of Prenatal Education on Perceptions of Epidural Acceptance
Primary Purpose
Labor Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prenatal education
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain focused on measuring intrapartum pain management, epidural
Eligibility Criteria
Inclusion Criteria:
- Women with viable intrauterine gestation seeking prenatal care
- Candidates for Intrapartum epidural analgesia
Exclusion Criteria:
- Intrapartum epidural analgesia is contraindicated
- Trial of labor is contraindicated.
- Patients planning an elective cesarean
Sites / Locations
- Santa Clara Valley Health and Hospital System
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
No Prenatal education
Receives Prenatal Education
Arm Description
These subjects will be randomized to receive routine prenatal epidural class (control group).
Subjects randomized to this group will receive educational video addressing the cultural and perceptions regarding the myths on epidural in either English or Spanish (Keeping an Open Mind: choices in Labor Anaglesia: an educational produce of the Society for Obstetric Anesthesia and perinatology)
Outcomes
Primary Outcome Measures
pre and post intervention PEQ survey results to elucidate the changes in perceptions of epiduralepidural based on the PEQ survey
All subjects will be asked to fill out the Perceptions on Epidural Questionnaire (PEQ) to elucidate their desire to receive intrapartum pain control & their attitude towards epidural to patients. Each survey will take approximately five to ten minutes to complete. The survey will be distributed in English and Spanish.
Secondary Outcome Measures
Full Information
NCT ID
NCT01709591
First Posted
October 15, 2012
Last Updated
August 10, 2020
Sponsor
Santa Clara Valley Health & Hospital System
1. Study Identification
Unique Protocol Identification Number
NCT01709591
Brief Title
Effect of Prenatal Education on Perceptions of Epidural Acceptance
Official Title
Effect of Targeted Prenatal Education on Perceptions of Epidural on Acceptance of Epidural Analgesia: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santa Clara Valley Health & Hospital System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to determine if targeted prenatal educational program on womens' perceptions of epidural increases the acceptance of intrapartum epidural analgesia relative to the control group.
Detailed Description
Racial/ethnic disparities exist in the proportion of patients receiving epidural analgesia. The purpose of our study is to determine if culturally-sensitive educational program targeting womens' perceptions of epidural increases the acceptance of intrapartum epidural use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
intrapartum pain management, epidural
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Prenatal education
Arm Type
No Intervention
Arm Description
These subjects will be randomized to receive routine prenatal epidural class (control group).
Arm Title
Receives Prenatal Education
Arm Type
Active Comparator
Arm Description
Subjects randomized to this group will receive educational video addressing the cultural and perceptions regarding the myths on epidural in either English or Spanish (Keeping an Open Mind: choices in Labor Anaglesia: an educational produce of the Society for Obstetric Anesthesia and perinatology)
Intervention Type
Behavioral
Intervention Name(s)
Prenatal education
Primary Outcome Measure Information:
Title
pre and post intervention PEQ survey results to elucidate the changes in perceptions of epiduralepidural based on the PEQ survey
Description
All subjects will be asked to fill out the Perceptions on Epidural Questionnaire (PEQ) to elucidate their desire to receive intrapartum pain control & their attitude towards epidural to patients. Each survey will take approximately five to ten minutes to complete. The survey will be distributed in English and Spanish.
Time Frame
One year time period
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women with viable intrauterine gestation seeking prenatal care
Candidates for Intrapartum epidural analgesia
Exclusion Criteria:
Intrapartum epidural analgesia is contraindicated
Trial of labor is contraindicated.
Patients planning an elective cesarean
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita Sit, MD
Organizational Affiliation
Santa Clara Valley Health and Hospital System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Clara Valley Health and Hospital System
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Prenatal Education on Perceptions of Epidural Acceptance
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