CSE v. Epidural for Postpartum Depression

Not Applicable

Completed

Conditions: Depression, Postpartum
Labor Pain

Interventions: Procedure: Epidural
Procedure: CSE
Drug: Bupivacaine / fentaNYL

Registration Number: NCT03022526

Lead Sponsor: Grace Lim, MD, MS

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 61

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CSE	Bupivacaine / fentaNYL	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
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
Epidural	Bupivacaine / fentaNYL	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
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

Primary Outcome Measures

Name	Time	Method
Edinburgh Postnatal Depression Score (EPDS)	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 Outcome Measures

Name	Time	Method
Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No)	2 Days Postpartum	Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.
Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No)	6 weeks postpartum	Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.
Pain Score on Average (BPI - Short Form)	3 months postpartum	Self-completed questionnaire, electronically completed. Pain scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Participants only answered this question if answered "yes" to question: "Have you had pain other than everyday kinds of pain today?"
Perceived Stress (PSS)	2 days postpartum	Self-completed questionnaire, electronically completed. Scores range from 0-40, with higher scores indicating higher perceived stress.
Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No)	3 months postpartum	Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.
Parent-Infant Attachment (MPAS)	3 months postpartum	Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.
Child Development (ASQ-3) Personal Social Score	3 months postpartum	Self-completed questionnaire, electronically completed. Scores range from 0-60, with higher scores indicating higher personal-social development.
Parenting Self-efficacy (PMP-SE)	6 weeks postpartum	Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy.
Parenting Self-Efficacy (PMP-SE)	3 months postpartum	Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy.
Edinburgh Postnatal Depression Score (EPDS)	3 months	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.