Skip to main content
OpenTrials
Completed

NCT Number: NCT03022526

CSE v. Epidural for Postpartum Depression

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression, Postpartum Agnosia Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Labor Pain Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Pregnancy Complications Puerperal Disorders Signs and Symptoms Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CSE

Procedure

Epidural

Procedure

Bupivacaine / fentaNYL

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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?"

  3. 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?"

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

Grace Lim, MD, MS

Other

Registry information

Official study title

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

Acronym: COPE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 16, 2017
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.