- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01709591
Effect of Prenatal Education on Perceptions of Epidural Acceptance
August 10, 2020 updated by: Santa Clara Valley Health & Hospital System
Effect of Targeted Prenatal Education on Perceptions of Epidural on Acceptance of Epidural Analgesia: a Randomized Controlled Trial
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
111
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
-
-
California
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San Jose, California, United States, 95128
- Santa Clara Valley Health and Hospital System
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-
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 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
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: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No Prenatal education
These subjects will be randomized to receive routine prenatal epidural class (control group).
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Active Comparator: Receives Prenatal Education
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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pre and post intervention PEQ survey results to elucidate the changes in perceptions of epiduralepidural based on the PEQ survey
Time Frame: One year time period
|
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.
|
One year time period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Anita Sit, MD, Santa Clara Valley Health and Hospital System
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
June 1, 2011
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
October 15, 2012
First Submitted That Met QC Criteria
October 16, 2012
First Posted (Estimate)
October 18, 2012
Study Record Updates
Last Update Posted (Actual)
August 11, 2020
Last Update Submitted That Met QC Criteria
August 10, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-081
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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