- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02557555
Patient Education on Labor Analgesia Options
Effects of Antenatal and Perinatal Education of Labor Analgesia Options on Maternal Anxiety, Labor Analgesia and Maternal Satisfaction With Labor Analgesia
Study Overview
Detailed Description
Many analgesic options exist for laboring parturients, but labor may not be the best time to start informing patients of their options. Many patients begin the labor process with a plan in place for their analgesia. Unfortunately, internet resources regarding labor analgesia that are available to the lay parturient are poor and often lead to misconceptions about the options and their risks. A significant number of patients refuse neuraxial analgesia based on misunderstandings, concerns about the procedure, or a lack of faith in the provider. Some women want a "natural childbirth" and/or control over their labor experience. Our study aimed at providing information and alternatives for labor analgesia in a simple written format.
The investigators will provide information of available labor analgesia options (epidural, combined spinal/epidural, spinal, remifentanil patient-controlled analgesia, and intravenous opioids) to expecting mothers. Using a pamphlet written in English or Spanish disseminated to pregnant women in clinic and upon arrival in the labor and delivery unit, the procedures and their risks and benefits will be explained in simple terms. In the Labor and Delivery Unit the patients will have an opportunity to ask questions of the anesthesia care giver regarding the options for analgesia. After delivery while on F Green, patients will be asked to complete a questionnaire addressing their thoughts about the pamphlets and their overall satisfaction with their labor analgesia. The analysis will focus on the utility and effect of education materials on maternal informed consent for labor analgesia, on maternal choice of analgesia modality, and on maternal anxiety regarding their labor analgesia plan.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New Jersey
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Newark, New Jersey, United States, 07103
- University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Postpartum women ages 18 and older
- Patients who speak and read English or Spanish
- Patients who received our informational pamphlet while pregnant or in labor
- Patients who are able to consent and make medical decisions
- Patients undergoing labor or trial of labor after cesarean delivery
- Patients who undergo cesarean delivery after trial of labor
Exclusion Criteria:
- Patients unable or unwilling to complete questionnaire
- Patients unable to consent or make medical decisions
- Patients less than 18 years of age
- Patients unable to read and speak English or Spanish
- Patients in whom any of the analgesic options were contraindicated
- Patients with a history of an anxiety disorder
- Patients with precipitous labor or late presentation that precluded an analgesic intervention
- Patients with fetal distress that precluded an analgesic intervention
- Patients planned for elective cesarean section.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Survey to Determine Utility and Effect of Educational Materials
Time Frame: expected average of no later than 48 hours following delivery
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In order to assess the educational value of the pamphlet provided to parturients we evaluated all the questions pertaining education.
There is no nominal value reported in units as all the data is merely described as the percentage of patients responding to educational questions.
For example, 93% of patients (91/98) responded Yes to the question -Do you think the pamphlet you received did a better job explaining your options for control of labor pain than what you answered in the previous question <patient research>?
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expected average of no later than 48 hours following delivery
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Collaborators and Investigators
Investigators
- Principal Investigator: Antonio Gonzalez-Fiol, MD, Rutgers, NJMS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20150001531
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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