Impact of Patient Choice for Epidural Potency on Maternal Satisfaction

February 10, 2026 updated by: Brendan Carvalho, Stanford University

This clinical trial will compare two different approaches to epidural analgesia during labor to see which approach leads to higher patient satisfaction after delivery.

Primary aim: determine whether one approach produces greater postpartum maternal satisfaction.

Secondary aims: compare pain control and side effects.

Participants are people in labor who receive epidural analgesia. They will receive routine clinical epidural care and complete brief, in-hospital questionnaires about pain and satisfaction.

All care is provided by the clinical team and safety practices remain unchanged.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Planned vaginal delivery
  • Patient requesting epidural labor analgesia
  • Gestational age >34 weeks

Exclusion Criteria:

  • Any contraindication to neuraxial block
  • History of chronic pain, anxiety or depression
  • Intolerance or allergy to local anesthetic or opioids
  • Cesarean delivery within 2 hours of epidural initiation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Choice
Participants will select a preferred epidural regimen, receive routine epidural care, and complete brief in-hospital questionnaires about pain and overall satisfaction.
Procedure: Patient-selected epidural management
Choice of epidural regimen
Active Comparator: No-choice
Participants will receive routine epidural care, and complete brief in-hospital questionnaires about pain and overall satisfaction.
Procedure: Standard epidural management
Hospital's usual epidural regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal satisfaction with epidural analgesia
Time Frame: 24 hours after delivery
Participant rating of overall satisfaction with pain care on a 5-point Likert scale (Describe your overall satisfaction with your epidural labor pain relief (Likert 1: very dissatisfied; 2: relatively dissatisfied; 3: fair; 4: relatively satisfied; 5: very satisfied)
24 hours after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance among four maternal satisfaction instruments
Time Frame: 24 hours after delivery
Correlation coefficient between four validated satisfaction instruments : (1) Single-item overall satisfaction (Likert 1-5), (2) Single-item willingness to have the same epidural again (6-point agreement: Disagree very much -> Agree very much), (3) Self-reported percent satisfaction (0-100%), and (4) Birth Satisfaction Scale-Revised (BSS-R) total score (scored per BSS-R guidelines).
24 hours after delivery
Concordance among intrapartum pain measurement methods
Time Frame: During labor, every one hour from epidural insertion until delivery
Statistical agreement between intrapartum pain measures: the 11-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain), the 11-point NRS coping ability (0 = totally unable to cope, 10 = totally able to cope), and a target pain measure.
During labor, every one hour from epidural insertion until delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

February 2, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-84223

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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