COPE: CSE v. Epidural for Postpartum Depression

• Sponsor: Grace Lim, MD, MS (Other)
• Overall Status: Completed
• CT.gov ID: NCT03022526
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Arms: 2
• Duration (Months): 35.9
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression, Postpartum; Labor Pain	Procedure: CSE; Procedure: Epidural; Drug: Bupivacaine / fentaNYL	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 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: Jan 1, 2017
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Edinburgh Postnatal Depression Score (EPDS) [6 weeks]

   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

1. Pain Score on Average (BPI - Short Form) [2 days postpartum]

   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. Pain Score on Average (BPI - Short Form) [6 weeks postpartum]

   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. Pain Score on Average (BPI - Short Form) [3 months postpartum]

   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?"

4. Perceived Stress (PSS) [2 days postpartum]

   Self-completed questionnaire, electronically completed. Scores range from 0-40, with higher scores indicating higher perceived stress.

5. Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No) [2 Days Postpartum]

   Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.

6. Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No) [6 weeks postpartum]

   Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.

7. Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No) [3 months postpartum]

   Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.

8. Parent-Infant Attachment (MPAS) [6 weeks postpartum]

   Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.

9. Parent-Infant Attachment (MPAS) [3 months postpartum]

   Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.

10. Child Development (ASQ-3) Personal Social Score [6 weeks postpartum]

    Self-completed questionnaire, electronically completed. Scores range from 0-60, with higher scores indicating higher personal-social development.

11. Child Development (ASQ-3) Personal Social Score [3 months postpartum]

    Self-completed questionnaire, electronically completed. Scores range from 0-60, with higher scores indicating higher personal-social development.

12. Parenting Self-efficacy (PMP-SE) [6 weeks postpartum]

    Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy.

13. Parenting Self-Efficacy (PMP-SE) [3 months postpartum]

    Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy.

14. Edinburgh Postnatal Depression Score (EPDS) [3 months]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Magee Womens Hospital of UPMC	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• Grace Lim, MD, MS

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 15, 2020

More Information

Publications

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

• Responsible Party: Grace Lim, MD, MS, Assistant Professor of Anesthesiology, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03022526
• Other Study ID Numbers: PRO16060602
• First Posted: Jan 16, 2017
• Last Update Posted: Aug 19, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Grace Lim, MD, MS, Assistant Professor of Anesthesiology, University of Pittsburgh: Pregnant; Analgesia; Labor analgesia; Epidural; Combined spinal epidural
• Additional relevant MeSH terms: Depression, Postpartum; Labor Pain; Depression; Depressive Disorder; Fentanyl; Bupivacaine

Study Results

Participant Flow

Pre-assignment Detail	We aimed to have 46 participants completing the trial, so enrolled until we hit that mark (greater than 46 enrolled due to loss to follow up).

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Period Title: Overall Study
STARTED	31	30
COMPLETED	21	25
NOT COMPLETED	10	5

Baseline Characteristics

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural	Total
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL	Total of all reporting groups
Overall Participants	31	30	61
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.36 (4.64)	27.56 (6.05)	27.46 (5.37)
Sex: Female, Male (Count of Participants)
Female	31 100%	30 100%	61 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	2 6.7%	2 3.3%
Not Hispanic or Latino	31 100%	28 93.3%	59 96.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 3.3%	1 1.6%
Asian	3 9.7%	0 0%	3 4.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 16.1%	6 20%	11 18%
White	20 64.5%	21 70%	41 67.2%
More than one race	2 6.5%	2 6.7%	4 6.6%
Unknown or Not Reported	1 3.2%	0 0%	1 1.6%
Region of Enrollment (participants) [Number]
United States	31 100%	30 100%	61 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Included all participants who completed electronically administered EPDS at the 6 week timepoint.

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Measure Participants	22	24
Mean (Standard Deviation) [score on a scale]	4.23 (3.93)	4.71 (5.82)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined Spinal Epidural (CSE), Epidural
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.7463
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Included all participants who completed electronically administered BPI short form at at the postpartum day 2 timepoint and who reported current pain at the time of assessment.

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Measure Participants	14	16
Mean (Standard Deviation) [score on a scale]	4.64 (2.13)	4.19 (2.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined Spinal Epidural (CSE), Epidural
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5764
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Included all participants who completed electronically administered BPI short form at at the 6 week timepoint and who reported current pain at the time of assessment.

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Measure Participants	5	1
Mean (Standard Deviation) [score on a scale]	3.00 (2.35)	4.00 (0.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined Spinal Epidural (CSE), Epidural
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.7169
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Included all participants who completed electronically administered BPI short form at at the 3 month timepoint and who reported current pain at the time of assessment.

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Measure Participants	2	2
Mean (Standard Deviation) [score on a scale]	4.50 (2.12)	2.00 (2.83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined Spinal Epidural (CSE), Epidural
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4226
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This population includes all participants who completed the electronically administered PSS at the postpartum day 2 timepoint.

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Measure Participants	25	28
Mean (Standard Deviation) [score on a scale]	13.08 (6.80)	12.39 (5.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined Spinal Epidural (CSE), Epidural
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6873
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This population includes all participants who completed the electronically administered breastfeeding form at the postpartum day 2 timepoint.

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Measure Participants	25	28
Count of Participants [Participants]	22 71%	18 60%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined Spinal Epidural (CSE), Epidural
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0452
	Comments
	Method	Chi-squared
	Comments

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This population includes all participants who completed the electronically administered breastfeeding form at the 6 week timepoint.

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Measure Participants	20	24
Count of Participants [Participants]	15 48.4%	12 40%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined Spinal Epidural (CSE), Epidural
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0899
	Comments
	Method	Chi-squared
	Comments

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This population includes all participants who completed the electronically administered breastfeeding form at the 3 month timepoint.

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Measure Participants	15	23
Count of Participants [Participants]	9 29%	8 26.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined Spinal Epidural (CSE), Epidural
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1265
	Comments
	Method	Chi-squared
	Comments

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This population includes all participants who completed the electronically administered MPAS at the 6 week timepoint.

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Measure Participants	22	24
Mean (Standard Deviation) [score on a scale]	84.09 (5.48)	87.68 (5.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined Spinal Epidural (CSE), Epidural
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0328
	Comments
	Method	t-test, 2 sided
	Comments

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This population includes all participants who completed the electronically administered MPAS at the 3 month timepoint.

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Measure Participants	15	23
Mean (Standard Deviation) [score on a scale]	88.08 (4.01)	88.70 (4.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined Spinal Epidural (CSE), Epidural
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6824
	Comments
	Method	t-test, 2 sided
	Comments

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This population includes all participants who completed the electronically administered ASQ at the 6 week timepoint.

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Measure Participants	22	24
Mean (Standard Deviation) [score on a scale]	43.64 (11.15)	46.04 (10.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined Spinal Epidural (CSE), Epidural
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.449
	Comments
	Method	t-test, 2 sided
	Comments

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This population includes all participants who completed the electronically administered ASQ at the 3 month timepoint.

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Measure Participants	15	23
Mean (Standard Deviation) [score on a scale]	45.00 (14.85)	47.33 (10.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined Spinal Epidural (CSE), Epidural
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5996
	Comments
	Method	t-test, 2 sided
	Comments

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This population includes all participants who completed the electronically administered PMP-SE at the 6 week timepoint.

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Measure Participants	22	24
Mean (Standard Deviation) [score on a scale]	71.45 (6.54)	71.92 (5.82)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined Spinal Epidural (CSE), Epidural
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.8009
	Comments
	Method	t-test, 2 sided
	Comments

14. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This population includes all participants who completed the electronically administered PMP-SE at the 3 month timepoint.

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Measure Participants	15	23
Mean (Standard Deviation) [score on a scale]	73.20 (5.92)	74.48 (6.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined Spinal Epidural (CSE), Epidural
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5422
	Comments
	Method	t-test, 2 sided
	Comments

15. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This population includes all participants who completed the electronically administered EPDS at the 3 month timepoint.

Arm/Group Title	Combined Spinal Epidural (CSE)	Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Measure Participants	15	23
Mean (Standard Deviation) [score on a scale]	3.53 (3.93)	3.96 (3.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Combined Spinal Epidural (CSE), Epidural
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.7374
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Data on adverse events were collected during the period of subject participation (e.g., 3rd trimester until 3 months postpartum, or labor until 3 months postpartum).
Arm/Group Title	Combined Spinal Epidural (CSE)		Epidural
Arm/Group 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 CSE Bupivacaine / fentaNYL		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 Epidural Bupivacaine / fentaNYL
All Cause Mortality
	Combined Spinal Epidural (CSE)		Epidural
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/30 (0%)
Serious Adverse Events
	Combined Spinal Epidural (CSE)		Epidural
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Combined Spinal Epidural (CSE)		Epidural
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.