Epidural Analgesia, ObstetricNCT07414407
Impact of Patient Choice for Epidural Potency on Maternal Satisfaction
A study testing Patient-selected epidural management and Standard epidural management in people with Epidural Analgesia, Obstetric and Maternal Satisfaction, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Epidural Analgesia, Obstetric, Maternal Satisfaction
- What is being tested?
- Patient-selected epidural management and Standard epidural management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Planned vaginal delivery
- Patient requesting epidural labor analgesia
- Gestational age >34 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Lucile Packard Children's Hospital
Palo Alto, California, 94304
Study Team, (650) 723-5403, brendan.carvalho@stanford.edu
About this study
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.
- Being tested
- Patient-selected epidural management, Standard epidural management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-selected epidural managementProcedure or surgery
Choice of epidural regimen
Standard epidural managementProcedure or surgery
Hospital's usual epidural regimen
| Study group | Role | What they receive |
|---|---|---|
| Choice | Experimental | Participants will select a preferred epidural regimen, receive routine epidural care, and complete brief in-hospital questionnaires about pain and overall satisfaction. Receives: Procedure: Patient-selected epidural management |
| No-choice | Active comparator | Participants will receive routine epidural care, and complete brief in-hospital questionnaires about pain and overall satisfaction. Receives: Procedure: Standard epidural management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal satisfaction with epidural analgesia
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)
Measured: 24 hours after delivery
Secondary outcomes (2)
Concordance among four maternal satisfaction instruments
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).
Measured: 24 hours after delivery
Concordance among intrapartum pain measurement methods
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.
Measured: During labor, every one hour from epidural insertion until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural Analgesia, ObstetricStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brendan Carvalho, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414407
- Sponsor's protocol ID
- IRB-84223
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Patient Choice for Epidural Potency on Maternal Satisfaction
- ClinicalTrials.gov ID
- NCT07414407
- Acronym / sponsor ID
- IRB-84223
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Choice | Experimental | Procedure: Patient-selected epidural managementParticipants will select a preferred epidural regimen, receive routine epidural care, and complete brief in-hospital questionnaires about pain and overall satisfaction. |
| No-choice | Active comparator | Procedure: Standard epidural managementParticipants will receive routine epidural care, and complete brief in-hospital questionnaires about pain and overall satisfaction. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Planned vaginal delivery
- Patient requesting epidural labor analgesia
- Gestational age >34 weeks
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-selected epidural managementChoice of epidural regimen | Procedure or surgery | Choice |
| Standard epidural managementHospital's usual epidural regimen | Procedure or surgery | No-choice |
Primary outcome
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)
2 secondary outcomes
Concordance among four maternal satisfaction instruments
Time frame: 24 hours after delivery
Concordance among intrapartum pain measurement methods
Time frame: During labor, every one hour from epidural insertion until delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Epidural Analgesia, Obstetric
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
Not yet recruitingPhase 4
Does the Volume of Medication Affect the Success of Labor Epidural Analgesia
Labor Pain and to Reduce Pain
Not yet recruitingObservational study
Perfusion Index Variability During Epidural Labor Analgesia
Labor Epidural Analgesia, Perfusion Index
RecruitingObservational study
Inertial Sensors for Obstetrical Walking Epidural Tracking
Pregnancy Related, Epidural; Anesthesia, Headache
Recruiting
Carbohydrate-Optimized Nutritional Solution Versus Electrolyte Hydration in Labor
Obstetric Labor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-selected epidural management and Standard epidural management in people with Epidural Analgesia, Obstetric and Maternal Satisfaction, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Team ((650) 723-5403, brendan.carvalho@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal satisfaction with epidural analgesia (time frame: 24 hours after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.