search
Back to results

CSE v. Epidural for Postpartum Depression (COPE)

Primary Purpose

Depression, Postpartum, Labor Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CSE
Epidural
Bupivacaine / fentaNYL
Sponsored by
Grace Lim, MD, MS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression, Postpartum focused on measuring Pregnant, Analgesia, Labor analgesia, Epidural, Combined spinal epidural

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Magee Womens Hospital of UPMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CSE

Epidural

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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?"
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?"
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?"
Perceived Stress (PSS)
Self-completed questionnaire, electronically completed. Scores range from 0-40, with higher scores indicating higher perceived stress.
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.
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.
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.
Parent-Infant Attachment (MPAS)
Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.
Parent-Infant Attachment (MPAS)
Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.
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.
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.
Parenting Self-efficacy (PMP-SE)
Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy.
Parenting Self-Efficacy (PMP-SE)
Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy.
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.

Full Information

First Posted
January 11, 2017
Last Updated
August 10, 2020
Sponsor
Grace Lim, MD, MS
search

1. Study Identification

Unique Protocol Identification Number
NCT03022526
Brief Title
CSE v. Epidural for Postpartum Depression
Acronym
COPE
Official Title
Combined Spinal Epidural v. Epidural Labor Analgesia for Postpartum Depression Symptoms (COPE Trial): Pilot Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Grace Lim, MD, MS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum, Labor Pain
Keywords
Pregnant, Analgesia, Labor analgesia, Epidural, Combined spinal epidural

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Magee Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18401329
Citation
Centers for Disease Control and Prevention (CDC). Prevalence of self-reported postpartum depressive symptoms--17 states, 2004-2005. MMWR Morb Mortal Wkly Rep. 2008 Apr 11;57(14):361-6.
Results Reference
background
PubMed Identifier
23487258
Citation
Wisner KL, Sit DK, McShea MC, Rizzo DM, Zoretich RA, Hughes CL, Eng HF, Luther JF, Wisniewski SR, Costantino ML, Confer AL, Moses-Kolko EL, Famy CS, Hanusa BH. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. JAMA Psychiatry. 2013 May;70(5):490-8. doi: 10.1001/jamapsychiatry.2013.87.
Results Reference
background
PubMed Identifier
16958723
Citation
Logsdon MC, Wisner KL, Pinto-Foltz MD. The impact of postpartum depression on mothering. J Obstet Gynecol Neonatal Nurs. 2006 Sep-Oct;35(5):652-8. doi: 10.1111/j.1552-6909.2006.00087.x.
Results Reference
background
PubMed Identifier
24797120
Citation
Ding T, Wang DX, Qu Y, Chen Q, Zhu SN. Epidural labor analgesia is associated with a decreased risk of postpartum depression: a prospective cohort study. Anesth Analg. 2014 Aug;119(2):383-392. doi: 10.1213/ANE.0000000000000107.
Results Reference
background
PubMed Identifier
15234824
Citation
Robertson E, Grace S, Wallington T, Stewart DE. Antenatal risk factors for postpartum depression: a synthesis of recent literature. Gen Hosp Psychiatry. 2004 Jul-Aug;26(4):289-95. doi: 10.1016/j.genhosppsych.2004.02.006.
Results Reference
background
PubMed Identifier
9629946
Citation
Righetti-Veltema M, Conne-Perreard E, Bousquet A, Manzano J. Risk factors and predictive signs of postpartum depression. J Affect Disord. 1998 Jun;49(3):167-80. doi: 10.1016/s0165-0327(97)00110-9.
Results Reference
background
PubMed Identifier
24140480
Citation
O'Hara MW, Wisner KL. Perinatal mental illness: definition, description and aetiology. Best Pract Res Clin Obstet Gynaecol. 2014 Jan;28(1):3-12. doi: 10.1016/j.bpobgyn.2013.09.002. Epub 2013 Oct 7.
Results Reference
background
Citation
Chapman C. The Psychophysiology of Pain by C. Richard Chapman. In: Fishman S, Ballantyne J, Rathmell JP, editors. Bonica's Management of Pain. Fourth ed. Baltimore, MD: Lippincott Williams & Wilkins; 2010. p. 375
Results Reference
background
PubMed Identifier
12512766
Citation
Gross KH, Wells CS, Radigan-Garcia A, Dietz PM. Correlates of self-reports of being very depressed in the months after delivery: results from the Pregnancy Risk Assessment Monitoring System. Matern Child Health J. 2002 Dec;6(4):247-53. doi: 10.1023/a:1021110100339.
Results Reference
background
Citation
O'Hara M, Swain A. Rates and risk of postpartum depression-A meta-analysis. Int Rev Psychiatry. 1996;8:37-54
Results Reference
background
PubMed Identifier
16730600
Citation
Schmidt RM, Wiemann CM, Rickert VI, Smith EO. Moderate to severe depressive symptoms among adolescent mothers followed four years postpartum. J Adolesc Health. 2006 Jun;38(6):712-8. doi: 10.1016/j.jadohealth.2005.05.023.
Results Reference
background
PubMed Identifier
20949886
Citation
Hirst KP, Moutier CY. Postpartum major depression. Am Fam Physician. 2010 Oct 15;82(8):926-33.
Results Reference
background
PubMed Identifier
19318144
Citation
Pearlstein T, Howard M, Salisbury A, Zlotnick C. Postpartum depression. Am J Obstet Gynecol. 2009 Apr;200(4):357-64. doi: 10.1016/j.ajog.2008.11.033.
Results Reference
background
PubMed Identifier
15883651
Citation
Lindahl V, Pearson JL, Colpe L. Prevalence of suicidality during pregnancy and the postpartum. Arch Womens Ment Health. 2005 Jun;8(2):77-87. doi: 10.1007/s00737-005-0080-1. Epub 2005 May 11.
Results Reference
background
PubMed Identifier
22215285
Citation
Davalos DB, Yadon CA, Tregellas HC. Untreated prenatal maternal depression and the potential risks to offspring: a review. Arch Womens Ment Health. 2012 Feb;15(1):1-14. doi: 10.1007/s00737-011-0251-1. Epub 2012 Jan 4.
Results Reference
background
PubMed Identifier
21515195
Citation
Murray L, Arteche A, Fearon P, Halligan S, Goodyer I, Cooper P. Maternal postnatal depression and the development of depression in offspring up to 16 years of age. J Am Acad Child Adolesc Psychiatry. 2011 May;50(5):460-70. doi: 10.1016/j.jaac.2011.02.001. Epub 2011 Apr 5.
Results Reference
background
PubMed Identifier
24108418
Citation
Pearson RM, Evans J, Kounali D, Lewis G, Heron J, Ramchandani PG, O'Connor TG, Stein A. Maternal depression during pregnancy and the postnatal period: risks and possible mechanisms for offspring depression at age 18 years. JAMA Psychiatry. 2013 Dec;70(12):1312-9. doi: 10.1001/jamapsychiatry.2013.2163.
Results Reference
background
PubMed Identifier
6384895
Citation
Melzack R. The myth of painless childbirth (the John J. Bonica lecture). Pain. 1984 Aug;19(4):321-337. doi: 10.1016/0304-3959(84)90079-4. No abstract available.
Results Reference
background
PubMed Identifier
18357852
Citation
Boudou M, Teissedre F, Walburg V, Chabrol H. [Association between the intensity of childbirth pain and the intensity of postpartum blues]. Encephale. 2007 Oct;33(5):805-10. doi: 10.1016/j.encep.2006.10.002. French.
Results Reference
background
PubMed Identifier
18818022
Citation
Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
Results Reference
background
PubMed Identifier
14995921
Citation
Hiltunen P, Raudaskoski T, Ebeling H, Moilanen I. Does pain relief during delivery decrease the risk of postnatal depression? Acta Obstet Gynecol Scand. 2004 Mar;83(3):257-61. doi: 10.1111/j.0001-6349.2004.0302.x.
Results Reference
background
PubMed Identifier
20121831
Citation
Vigod SN, Villegas L, Dennis CL, Ross LE. Prevalence and risk factors for postpartum depression among women with preterm and low-birth-weight infants: a systematic review. BJOG. 2010 Apr;117(5):540-50. doi: 10.1111/j.1471-0528.2009.02493.x. Epub 2010 Jan 29.
Results Reference
background
PubMed Identifier
20605900
Citation
Ross LE, McQueen K, Vigod S, Dennis CL. Risk for postpartum depression associated with assisted reproductive technologies and multiple births: a systematic review. Hum Reprod Update. 2011 Jan-Feb;17(1):96-106. doi: 10.1093/humupd/dmq025. Epub 2010 Jul 6.
Results Reference
background
PubMed Identifier
23723741
Citation
Howard LM, Oram S, Galley H, Trevillion K, Feder G. Domestic violence and perinatal mental disorders: a systematic review and meta-analysis. PLoS Med. 2013;10(5):e1001452. doi: 10.1371/journal.pmed.1001452. Epub 2013 May 28.
Results Reference
background
PubMed Identifier
25269760
Citation
Sanger C, Iles JE, Andrew CS, Ramchandani PG. Associations between postnatal maternal depression and psychological outcomes in adolescent offspring: a systematic review. Arch Womens Ment Health. 2015 Apr;18(2):147-162. doi: 10.1007/s00737-014-0463-2. Epub 2014 Oct 2.
Results Reference
background

Learn more about this trial

CSE v. Epidural for Postpartum Depression

We'll reach out to this number within 24 hrs