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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02557555
Enrollment
100
Registered
2015-09-23
Start date
2015-09-30
Completion date
2017-03-31
Last updated
2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Analgesia

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.

Interventions

patients will receive pamphlet on labor analgesia options.

Sponsors

Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Survey to Determine Utility and Effect of Educational Materialsexpected average of no later than 48 hours following deliveryIn 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\>?

Countries

United States

Participant flow

Participants by arm

ArmCount
Labor Pain Control Pamphlet
All English or Spanish speaking patients were provided with a pamphlet during their prenatal visits and then again when entering the labor and delivery floor. The pamphlet contained information regarding labor analgesia alternatives (i.e Epidural, remifentanil PCA, morphine bolus, etc). After delivery, the patients were approached and asked to respond to a brief questionnaire.
100
Total100

Baseline characteristics

CharacteristicLabor Pain Control Pamphlet
Age, Customized
18-45 years
100 Participants
Patients completing survey100 Participants
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United States
100 participants
Sex: Female, Male
Female
100 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

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 \<patient research\>?

Time frame: expected average of no later than 48 hours following delivery

Population: The answers from 100 female patients, ages 18-45 admitted to the L\&D who answered our survey were analyzed to gage the educational value of our labor analgesia informational pamphlet.

ArmMeasureGroupValue (NUMBER)
Yes %Survey to Determine Utility and Effect of Educational MaterialsPamphlet better explained options for pain93 percentage of patients responding
Yes %Survey to Determine Utility and Effect of Educational MaterialsPamphlet information helped to reduce anxiety90 percentage of patients responding
Yes %Survey to Determine Utility and Effect of Educational MaterialsResearched options for labor pain79 percentage of patients responding
Yes %Survey to Determine Utility and Effect of Educational MaterialsInformation corrected any misconception71 percentage of patients responding
Yes %Survey to Determine Utility and Effect of Educational MaterialsWritten information should always be available100 percentage of patients responding
Yes %Survey to Determine Utility and Effect of Educational MaterialsPamphlet should be given before onset labor pain97 percentage of patients responding
No %Survey to Determine Utility and Effect of Educational MaterialsWritten information should always be available0 percentage of patients responding
No %Survey to Determine Utility and Effect of Educational MaterialsResearched options for labor pain21 percentage of patients responding
No %Survey to Determine Utility and Effect of Educational MaterialsPamphlet better explained options for pain7 percentage of patients responding
No %Survey to Determine Utility and Effect of Educational MaterialsPamphlet should be given before onset labor pain3 percentage of patients responding
No %Survey to Determine Utility and Effect of Educational MaterialsPamphlet information helped to reduce anxiety10 percentage of patients responding
No %Survey to Determine Utility and Effect of Educational MaterialsInformation corrected any misconception29 percentage of patients responding
p-value: <0.0001Test of equal proportion (50/50)
p-value: <0.0001Test of equal proportion (50/50)
p-value: <0.0001Test of equal proportion (50/50)
p-value: <0.0001Test of equal proportion (50/50)
p-value: 0.0002Test of equal proportion (50/50)
p-value: <0.0001Test of equal proportion (50/50)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026