NCT01709591

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

7.2 years

First QC Date

October 15, 2012

Last Update Submit

August 10, 2020

Conditions

Keywords

intrapartum pain management, epidural

Outcome Measures

Primary Outcomes (1)

  • 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.

    One year time period

Study Arms (2)

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)

Behavioral: Prenatal education

Interventions

Receives Prenatal Education

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women with viable intrauterine gestation seeking prenatal care
  • Candidates for Intrapartum epidural analgesia

You may not qualify if:

  • Intrapartum epidural analgesia is contraindicated
  • Trial of labor is contraindicated.
  • Patients planning an elective cesarean

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Clara Valley Health and Hospital System

San Jose, California, 95128, United States

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Prenatal Education

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Education as TopicHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Anita Sit, MD

    Santa Clara Valley Health and Hospital System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2012

First Posted

October 18, 2012

Study Start

June 1, 2011

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 11, 2020

Record last verified: 2020-08

Locations