Clinical trial NCT03022526: CSE v. Epidural for Postpartum Depression
Official title: Combined Spinal Epidural v. Epidural Labor Analgesia for Postpartum Depression Symptoms (COPE Trial): Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Labor Pain
Keywords: Pregnant
Analgesia
Labor analgesia
Epidural
Combined spinal epidural
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Edinburgh Postnatal Depression Score (EPDS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Pain Score on Average (BPI - Short Form)
timeFrame: 2 days postpartum
measure: Pain Score on Average (BPI - Short Form)
timeFrame: 6 weeks postpartum
measure: Pain Score on Average (BPI - Short Form)
timeFrame: 3 months postpartum
measure: Perceived Stress (PSS)
timeFrame: 2 days postpartum
measure: Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No)
timeFrame: 2 Days Postpartum
measure: Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No)
timeFrame: 6 weeks postpartum
measure: Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No)
timeFrame: 3 months postpartum
measure: Parent-Infant Attachment (MPAS)
timeFrame: 6 weeks postpartum
measure: Parent-Infant Attachment (MPAS)
timeFrame: 3 months postpartum
measure: Child Development (ASQ-3) Personal Social Score
timeFrame: 6 weeks postpartum
measure: Child Development (ASQ-3) Personal Social Score
timeFrame: 3 months postpartum
measure: Parenting Self-efficacy (PMP-SE)
timeFrame: 6 weeks postpartum
measure: Parenting Self-Efficacy (PMP-SE)
timeFrame: 3 months postpartum
measure: Edinburgh Postnatal Depression Score (EPDS)
timeFrame: 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Womens Hospital of UPMC
state: Pennsylvania
Study officials:
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