N/A N=61 Randomized Double-blind Prevention

CSE v. Epidural for Postpartum Depression

Depression, Postpartum · Labor Pain

Bottom Line

View on ClinicalTrials.gov: NCT03022526 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Edinburgh Postnatal Depression Score (EPDS) — 4.23; 4.71 score on a scale — p=0.7463

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CSE (Procedure); Epidural (Procedure); Bupivacaine / fentaNYL (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Grace Lim, MD, MS
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Edinburgh Postnatal Depression Score (EPDS)	3.53; 3.96	0.7374
SECONDARY Pain Score on Average (BPI - Short Form)	4.50; 2.00	0.4226
SECONDARY Pain Score on Average (BPI - Short Form)	4.50; 2.00	0.4226
SECONDARY Pain Score on Average (BPI - Short Form)	4.50; 2.00	0.4226
SECONDARY Perceived Stress (PSS)	13.08; 12.39	0.6873
SECONDARY Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No)	22; 18	0.0452 sig
SECONDARY Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No)	15; 12	0.0899
SECONDARY Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No)	9; 8	0.1265
SECONDARY Parent-Infant Attachment (MPAS)	88.08; 88.70	0.6824
SECONDARY Parent-Infant Attachment (MPAS)	88.08; 88.70	0.6824
SECONDARY Child Development (ASQ-3) Personal Social Score	45.00; 47.33	0.5996
SECONDARY Child Development (ASQ-3) Personal Social Score	45.00; 47.33	0.5996
SECONDARY Parenting Self-efficacy (PMP-SE)	73.20; 74.48	0.5422
SECONDARY Parenting Self-Efficacy (PMP-SE)	73.20; 74.48	0.5422
SECONDARY Edinburgh Postnatal Depression Score (EPDS)	3.53; 3.96	0.7374

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03022526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.