CSE v. Epidural for Postpartum Depression

Study Overview
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Brief Summary
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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.

Official Title
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Combined Spinal Epidural v. Epidural Labor Analgesia for Postpartum Depression Symptoms (COPE Trial): Pilot Randomized Control Trial

Conditions
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Depression, Postpartum, Labor Pain

Intervention / Treatment
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* Procedure: CSE
* Procedure: Epidural
* Drug: Bupivacaine / fentaNYL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSE<br>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 | Procedure: CSE<br> <br> Drug: Bupivacaine / fentaNYL<br> <br> |
| Active Comparator: Epidural<br>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 | Procedure: Epidural<br> <br> Drug: Bupivacaine / fentaNYL<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edinburgh Postnatal Depression Score (EPDS) | 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score on Average (BPI - Short Form) | 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? | 2 days postpartum | 
| Pain Score on Average (BPI - Short Form) | 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? | 6 weeks postpartum | 
| Pain Score on Average (BPI - Short Form) | 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? | 3 months postpartum | 
| Perceived Stress (PSS) | Self-completed questionnaire, electronically completed. Scores range from 0-40, with higher scores indicating higher perceived stress. | 2 days postpartum | 
| Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No) | Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point. | 2 Days Postpartum | 
| Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No) | Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point. | 6 weeks postpartum | 
| Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No) | Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point. | 3 months postpartum | 
| Parent-Infant Attachment (MPAS) | Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment. | 6 weeks postpartum | 
| Parent-Infant Attachment (MPAS) | Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment. | 3 months postpartum | 
| Child Development (ASQ-3) Personal Social Score | Self-completed questionnaire, electronically completed. Scores range from 0-60, with higher scores indicating higher personal-social development. | 6 weeks postpartum | 
| Child Development (ASQ-3) Personal Social Score | Self-completed questionnaire, electronically completed. Scores range from 0-60, with higher scores indicating higher personal-social development. | 3 months postpartum | 
| Parenting Self-efficacy (PMP-SE) | Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy. | 6 weeks postpartum | 
| Parenting Self-Efficacy (PMP-SE) | Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy. | 3 months postpartum | 
| Edinburgh Postnatal Depression Score (EPDS) | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnant, Analgesia, Labor analgesia, Epidural, Combined spinal epidural