CSE v. Epidural for Postpartum Depression

NCT03022526 | Completed Results

• 1 other identifier: PRO16060602
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Postpartum; Labor Pain

Keywords

Pregnant; Analgesia; Labor analgesia; Epidural; Combined spinal epidural

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Pain Score on Average (BPI - Short Form)

  2 days postpartum

• Pain Score on Average (BPI - Short Form)

  6 weeks postpartum

• Pain Score on Average (BPI - Short Form)

  3 months postpartum

• Perceived Stress (PSS)

  2 days postpartum

• Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No)

  2 Days Postpartum

Study Arms (2)

CSE

EXPERIMENTAL

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

Epidural

ACTIVE COMPARATOR

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; Drug: Bupivacaine / fentaNYL

Interventions

CSE PROCEDURE

CSE

Epidural PROCEDURE

Epidural

Bupivacaine / fentaNYL DRUG

CSE; Epidural

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Grace Lim, MD, MS: lead

Study Sites (1)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (25)

• 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.

  PMID: 18401329 BACKGROUND

• 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.

  PMID: 23487258 BACKGROUND

• 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.

  PMID: 16958723 BACKGROUND

• 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.

  PMID: 24797120 BACKGROUND

• 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.

  PMID: 15234824 BACKGROUND

• 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.

  PMID: 9629946 BACKGROUND

• 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.

  PMID: 24140480 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 12512766 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 16730600 BACKGROUND

• Hirst KP, Moutier CY. Postpartum major depression. Am Fam Physician. 2010 Oct 15;82(8):926-33.

  PMID: 20949886 BACKGROUND

• 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.

  PMID: 19318144 BACKGROUND

• 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.

  PMID: 15883651 BACKGROUND

• 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.

  PMID: 22215285 BACKGROUND

• 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.

  PMID: 21515195 BACKGROUND

• 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.

  PMID: 24108418 BACKGROUND

• 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.

  PMID: 6384895 BACKGROUND

• 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.

  PMID: 18357852 BACKGROUND

• 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.

  PMID: 18818022 BACKGROUND

• 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.

  PMID: 14995921 BACKGROUND

• 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.

  PMID: 20121831 BACKGROUND

• 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.

  PMID: 20605900 BACKGROUND

• 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.

  PMID: 23723741 BACKGROUND

• 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.

  PMID: 25269760 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum; Labor Pain; Agnosia

Interventions

Injections, Epidural; Bupivacaine; Fentanyl

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Grace Lim
• Organization: University of Pittsburgh

limkg2@upmc.edu

412-641-2179

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 16, 2017
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 19, 2020
• Results First Posted: August 10, 2020

Record last verified: 2020-08

Locations

US (1)