Patient Education on Labor Analgesia Options

NCT ID: NCT02557555

Last Updated: 2019-10-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-03-31

Brief Summary

The purpose of this study is to learn how the investigators can better educate pregnant patients about the options open to them for pain relief during labor. Patients will receive educational pamphlet during prenatal clinic visit and again on admission to labor and delivery. The options for analgesia will be discussed by anesthesia care provider. Patient will be asked to complete a survey on the post partum unit.

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.

Conditions

Labor Analgesia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

educational information

patients will receive pamphlet on labor analgesia options.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Antonio Gonzalez Fiol, Anesthesiology Department

Assistant Professor Director of Obstetric Anesthesia Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Gonzalez-Fiol, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, NJMS

Locations

University Hospital

Newark, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

20150001531

Identifier Type: -

Identifier Source: org_study_id