CSE v. Epidural for Postpartum Depression (COPE)

August 10, 2020 updated by: Grace Lim, MD, MS

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Womens Hospital of UPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: CSE
Drug: Bupivacaine / fentaNYL
Active Comparator: 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
Drug: Bupivacaine / fentaNYL
Procedure: Epidural

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score on Average (BPI - Short Form)
Time Frame: 2 days 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?"
2 days postpartum
Pain Score on Average (BPI - Short Form)
Time Frame: 6 weeks 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?"
6 weeks postpartum
Pain Score on Average (BPI - Short Form)
Time Frame: 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?"
3 months postpartum
Perceived Stress (PSS)
Time Frame: 2 days postpartum
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)
Time Frame: 2 Days Postpartum
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)
Time Frame: 6 weeks postpartum
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)
Time Frame: 3 months postpartum
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)
Time Frame: 6 weeks postpartum
Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.
6 weeks postpartum
Parent-Infant Attachment (MPAS)
Time Frame: 3 months postpartum
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
Time Frame: 6 weeks postpartum
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
Time Frame: 3 months postpartum
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)
Time Frame: 6 weeks postpartum
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)
Time Frame: 3 months postpartum
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)
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grace Lim, MD, MS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 12, 2017

First Posted (Estimate)

January 16, 2017

Study Record Updates

Last Update Posted (Actual)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO16060602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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