Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 5 of 127 for:    depression pittsburgh | Open Studies

CSE v. Epidural for Postpartum Depression (COPE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Grace Lim, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT03022526
First received: January 11, 2017
Last updated: January 12, 2017
Last verified: January 2017
  Purpose
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 Intervention
Depression, Postpartum
Labor Pain
Procedure: CSE
Procedure: Epidural

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Combined Spinal Epidural v. Epidural Labor Analgesia for Postpartum Depression Symptoms (COPE Trial): Pilot Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Edinburgh Postnatal Depression Score (EPDS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Self-completed questionnaire, electronically completed


Secondary Outcome Measures:
  • Edinburgh Postnatal Depression Score (EPDS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Self-completed questionnaire, electronically completed

  • Parent-Infant Attachment (MPAS) [ Time Frame: 6 weeks postpartum, 3 months postpartum ] [ Designated as safety issue: No ]
    Self-completed questionnaire, electronically completed

  • Child Development (ASQ-3) [ Time Frame: 6 weeks postpartum, 3 months postpartum ] [ Designated as safety issue: No ]
    Self-completed questionnaire, electronically completed

  • Breastfeeding (Yes/No) [ Time Frame: 2 days postpartum, 6 weeks postpartum, 3 months postpartum ] [ Designated as safety issue: No ]
    Self-completed questionnaire, electronically completed

  • Parenting self-efficacy (PMP-SE) [ Time Frame: 6 weeks postpartum, 3 months postpartum ] [ Designated as safety issue: No ]
    Self-completed questionnaire, electronically completed

  • Pain (BPI - Short Form) [ Time Frame: 2 days postpartum, 6 weeks postpartum, 3 months postpartum ] [ Designated as safety issue: No ]
    Self-completed questionnaire, electronically completed

  • Perceived Stress (PSS) [ Time Frame: 2 days postpartum ] [ Designated as safety issue: No ]
    Self-completed questionnaire, electronically completed


Estimated Enrollment: 46
Study Start Date: January 2017
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
University of Pittsburgh
  More Information

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 
Study First Received: January 11, 2017
Last Updated: January 12, 2017
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of Pittsburgh:
Pregnant
Analgesia
Labor analgesia
Epidural
Combined spinal epidural

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Labor Pain
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on January 17, 2017