Combined Spinal Epidural v. Epidural Labor Analgesia for Postpartum Depression Symptoms (COPE Trial): Pilot Randomized Control Trial
Overview
- Phase
- Not Applicable
- Intervention
- CSE
- Conditions
- Depression, Postpartum
- Sponsor
- Grace Lim, MD, MS
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Edinburgh Postnatal Depression Score (EPDS)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this pilot prospective randomized control trial is to compare the initiation of labor epidural analgesia by combined spinal epidural vs. epidural for the influence on risk for postpartum depression symptoms. Investigators will randomize women to the receipt of CSE or E during labor, after measuring baseline psychological, psychosocial, and psychophysical factors related to pain and depression. The immediate research goals are to understand whether the association between labor pain and PPD is modifiable through the use of tailored anesthetic techniques.
Investigators
Grace Lim, MD, MS
Assistant Professor of Anesthesiology
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •Nulliparous (no prior childbirth)
- •Singleton gestation
- •Third trimester
- •Healthy pregnancy
- •English proficiency (surveys validated in English)
- •Planned vaginal delivery
- •Planning to use labor epidural analgesia
- •Term delivery (\>/= 37.0 weeks)
Exclusion Criteria
- •Severe maternal disease
- •Severe fetal disease
- •Delivery not at term (delivery prior to 37.0 weeks)
- •Contraindications to neuraxial anesthesia known at the time of enrollment
- •Cesarean delivery WITHOUT labor
- •Planning to list infant for adoption
- •Did not receive epidural analgesia (either CSE or E) for labor
Arms & Interventions
CSE
intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL
Intervention: CSE
CSE
intrathecal bupivacaine 2.5mg + fentanyl 15mcg followed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL
Intervention: Bupivacaine / fentaNYL
Epidural
epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL
Intervention: Epidural
Epidural
epidural bupivacaine 0.083% + fentanyl 2mcg/mL (8mL) followed by fentanyl 100mcg (2mL); follwed by infusion (PCEA): bupivacaine 0.083% with fentanyl 2mcg/mL: basal 8mL/hr, demand 8mL, 2 boluses per hour allowed, total maximum hourly allowance 24mL
Intervention: Bupivacaine / fentaNYL
Outcomes
Primary Outcomes
Edinburgh Postnatal Depression Score (EPDS)
Time Frame: 6 weeks
Self-completed questionnaire, electronically completed. Scores range from 0-30, with higher score indicating higher likelihood of depressive illness. A score of 10 or greater is characterized as possible depression.
Secondary Outcomes
- Pain Score on Average (BPI - Short Form)(3 months postpartum)
- Perceived Stress (PSS)(2 days postpartum)
- Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No)(2 Days Postpartum)
- Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No)(6 weeks postpartum)
- Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No)(3 months postpartum)
- Parent-Infant Attachment (MPAS)(3 months postpartum)
- Child Development (ASQ-3) Personal Social Score(3 months postpartum)
- Parenting Self-efficacy (PMP-SE)(6 weeks postpartum)
- Parenting Self-Efficacy (PMP-SE)(3 months postpartum)
- Edinburgh Postnatal Depression Score (EPDS)(3 months)