Labor PainNCT01709591
Effect of Prenatal Education on Perceptions of Epidural Acceptance
A study testing Prenatal education in people with Labor Pain, run by Santa Clara Valley Health & Hospital System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Prenatal education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with viable intrauterine gestation seeking prenatal care
- Candidates for Intrapartum epidural analgesia
Who cannot join
- Intrapartum epidural analgesia is contraindicated
- Trial of labor is contraindicated.
- Patients planning an elective cesarean
Trial locations and contacts
1 site in 1 country.
United States1 site
Santa Clara Valley Health and Hospital System
San Jose, California, 95128
About this study
Official title: 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.
Read the 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.
- Conditions
- Labor Pain
- Being tested
- Prenatal education
- Keywords
- intrapartum pain management, epidural
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| No Prenatal education | No intervention | These subjects will be randomized to receive routine prenatal epidural class (control group). |
| Receives Prenatal Education | Active comparator | 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) Receives: Behavioral: Prenatal education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year time period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startJun 2011
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Clara Valley Health & Hospital System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita Sit, MD, Principal investigator, Santa Clara Valley Health and Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709591
- Sponsor's protocol ID
- 10-081
- Status last verified
- Aug 2020
- First submitted
- 15 Oct 2012
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Targeted Prenatal Education on Perceptions of Epidural on Acceptance of Epidural Analgesia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01709591
- Acronym / sponsor ID
- 10-081
- Conditions
- Labor Pain
- Keywords
- intrapartum pain management, epidural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Santa Clara Valley Health & Hospital SystemUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Prenatal education | No intervention | –These subjects will be randomized to receive routine prenatal epidural class (control group). |
| Receives Prenatal Education | Active comparator | Behavioral: Prenatal educationSubjects 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women with viable intrauterine gestation seeking prenatal care
- Candidates for Intrapartum epidural analgesia
Key exclusion criteria (3 listed)
- Intrapartum epidural analgesia is contraindicated
- Trial of labor is contraindicated.
- Patients planning an elective cesarean
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prenatal education | Behavioural | Receives Prenatal Education |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Sit, MD principal investigator
Santa Clara Valley Health and Hospital System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal education in people with Labor Pain, run by Santa Clara Valley Health & Hospital System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.