Patient Education on Labor Analgesia Options

Labor Analgesia Clinical Trial

Official title:

Effects of Antenatal and Perinatal Education of Labor Analgesia Options on Maternal Anxiety, Labor Analgesia and Maternal Satisfaction With Labor Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557555
• Other study ID #: 20150001531
• Status: Completed
• Start date: September 2015
• Est. completion date: March 2017

Study information

• Verified date: October 2019
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Analgesia

Intervention

Other:
• educational information
patients will receive pamphlet on labor analgesia options.

Locations

Country	Name	City	State
United States	University Hospital	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survey to Determine Utility and Effect of Educational Materials	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	expected average of no later than 48 hours following delivery