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CSE v. Epidural for Postpartum Depression (COPE)

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ClinicalTrials.gov Identifier: NCT03022526
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Grace Lim, MD, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Depression, Postpartum Labor Pain Procedure: CSE Procedure: Epidural Drug: Bupivacaine / fentaNYL Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Combined Spinal Epidural v. Epidural Labor Analgesia for Postpartum Depression Symptoms (COPE Trial): Pilot Randomized Control Trial
Study Start Date : January 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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
Procedure: Epidural
Drug: Bupivacaine / fentaNYL



Primary Outcome Measures :
  1. Edinburgh Postnatal Depression Score (EPDS) [ Time Frame: 6 weeks ]
    Self-completed questionnaire, electronically completed


Secondary Outcome Measures :
  1. Edinburgh Postnatal Depression Score (EPDS) [ Time Frame: 3 months ]
    Self-completed questionnaire, electronically completed

  2. Parent-Infant Attachment (MPAS) [ Time Frame: 6 weeks postpartum, 3 months postpartum ]
    Self-completed questionnaire, electronically completed

  3. Child Development (ASQ-3) [ Time Frame: 6 weeks postpartum, 3 months postpartum ]
    Self-completed questionnaire, electronically completed

  4. Breastfeeding (Yes/No) [ Time Frame: 2 days postpartum, 6 weeks postpartum, 3 months postpartum ]
    Self-completed questionnaire, electronically completed

  5. Parenting self-efficacy (PMP-SE) [ Time Frame: 6 weeks postpartum, 3 months postpartum ]
    Self-completed questionnaire, electronically completed

  6. Pain (BPI - Short Form) [ Time Frame: 2 days postpartum, 6 weeks postpartum, 3 months postpartum ]
    Self-completed questionnaire, electronically completed

  7. Perceived Stress (PSS) [ Time Frame: 2 days postpartum ]
    Self-completed questionnaire, electronically completed



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022526


Contacts
Contact: Grace Lim, MD MS 4126414260 limkg2@upmc.edu
Contact: Lia Farrell, BS 412-641-2179 farrelll2@upmc.edu

Locations
United States, Pennsylvania
Magee Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Lia M Farrell, B.S.    412-641-2179    farrelll2@upmc.edu   
Sponsors and Collaborators
Grace Lim, MD

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

Responsible Party: Grace Lim, MD, Assistant Professor of Anesthesiology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03022526     History of Changes
Other Study ID Numbers: PRO16060602
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Grace Lim, MD, University of Pittsburgh:
Pregnant
Analgesia
Labor analgesia
Epidural
Combined spinal epidural

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Puerperal Disorders
Labor Pain
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pregnancy Complications
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General