Epidural Analgesia, Obstetric, Maternal Satisfaction
Conditions
Brief 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. 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.
Interventions
PROCEDUREPatient-selected epidural management
Choice of epidural regimen
PROCEDUREStandard epidural management
Hospital's usual epidural regimen
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal satisfaction with epidural analgesia | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concordance among four maternal satisfaction instruments | 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). |
| Concordance among intrapartum pain measurement methods | 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. |
Countries
United States
Contacts
CONTACTStudy Team
Outcome results
None listed