CSE v. Epidural for Postpartum Depression

Labor Pain Clinical Trial

— COPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03022526
• Other study ID #: PRO16060602
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Labor Pain

Intervention

Procedure:
• CSE

• Epidural

Drug:
• Bupivacaine / fentaNYL

Locations

Country	Name	City	State
United States	Magee Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Grace Lim, MD, MS

Country where clinical trial is conducted

United States, 

References & Publications (25)

Boudou M, Teissèdre 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. French. — View 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. — View 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

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. Review. — View 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):383-92. doi: 10.1213/ANE.0000000000000107. — View 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. — View 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. — View 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. — View Citation

Hirst KP, Moutier CY. Postpartum major depression. Am Fam Physician. 2010 Oct 15;82(8):926-33. Review. — View 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. Review. — View 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. Epub 2005 May 11. Review. — View 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. Review. — View Citation

Melzack R. The myth of painless childbirth (the John J. Bonica lecture). Pain. 1984 Aug;19(4):321-37. Review. — View 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. — View Citation

O'Hara M, Swain A. Rates and risk of postpartum depression-A meta-analysis. Int Rev Psychiatry. 1996;8:37-54

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. Review. — View 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. Review. — View 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. — View Citation

Righetti-Veltema M, Conne-Perréard E, Bousquet A, Manzano J. Risk factors and predictive signs of postpartum depression. J Affect Disord. 1998 Jun;49(3):167-80. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Perceived Stress (PSS)	Self-completed questionnaire, electronically completed. Scores range from 0-40, with higher scores indicating higher perceived stress.	2 days postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	Parent-Infant Attachment (MPAS)	Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.	6 weeks postpartum
Secondary	Parent-Infant Attachment (MPAS)	Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.	3 months postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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