CSE v. Epidural for Postpartum Depression (COPE)

Grace Lim, MD, MS

Status: Completed

Conditions: Labor Pain; Depression, Postpartum

Treatments: Drug: Bupivacaine / fentaNYL; Procedure: CSE; Procedure: Epidural

Study type: Interventional

Funder types: Other

Identifiers

NCT03022526

PRO16060602

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 2 patient groups

CSE

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine / fentaNYL

Procedure: CSE

Epidural

Active Comparator group

Description:

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

Treatment:

Procedure: Epidural

Drug: Bupivacaine / fentaNYL