Health TrialsbyHealthPanel

Impact of Patient Choice for Epidural Potency on Maternal Satisfaction

ConditionsEpidural Analgesia, ObstetricMaternal Satisfaction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Planned vaginal delivery

Patient requesting epidural labor analgesia

Gestational age >34 weeks

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Patient-selected epidural management

    Procedure/Surgery

    Choice of epidural regimen

  • Standard epidural management

    Procedure/Surgery

    Hospital's usual epidural regimen

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: ChoiceExperimental treatment 1 intervention
Group B: No-choiceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
24 hours after delivery

Secondary outcomes

1

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).

Time frame
24 hours after delivery
2

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.

Time frame
During labor, every one hour from epidural insertion until delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: