Trial Outcomes & Findings for CSE v. Epidural for Postpartum Depression (NCT NCT03022526)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

61 participants

Primary outcome timeframe

6 weeks

Results posted on

2020-08-19

Participant Flow

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).

Participant milestones

Participant milestones
Measure	Combined Spinal Epidural (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 CSE Bupivacaine / fentaNYL	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 Epidural Bupivacaine / fentaNYL
Overall Study STARTED	31	30
Overall Study COMPLETED	21	25
Overall Study NOT COMPLETED	10	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CSE v. Epidural for Postpartum Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combined Spinal Epidural (CSE) n=31 Participants 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 n=30 Participants 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 n=61 Participants Total of all reporting groups
Age, Continuous	27.36 years STANDARD_DEVIATION 4.64 • n=5 Participants	27.56 years STANDARD_DEVIATION 6.05 • n=7 Participants	27.46 years STANDARD_DEVIATION 5.37 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	28 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	30 participants n=7 Participants	61 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

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

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.

Outcome measures

Outcome measures
Measure	Combined Spinal Epidural (CSE) n=22 Participants 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 n=24 Participants 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
Edinburgh Postnatal Depression Score (EPDS)	4.23 score on a scale Standard Deviation 3.93	4.71 score on a scale Standard Deviation 5.82

SECONDARY outcome

Timeframe: 2 days postpartum

Population: 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.

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?"

Outcome measures

Outcome measures
Measure	Combined Spinal Epidural (CSE) n=14 Participants 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 n=16 Participants 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
Pain Score on Average (BPI - Short Form)	4.64 score on a scale Standard Deviation 2.13	4.19 score on a scale Standard Deviation 2.26

SECONDARY outcome

Timeframe: 6 weeks postpartum

Population: 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.

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?"

Outcome measures

Outcome measures
Measure	Combined Spinal Epidural (CSE) n=5 Participants 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 n=1 Participants 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
Pain Score on Average (BPI - Short Form)	3.00 score on a scale Standard Deviation 2.35	4.00 score on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: 3 months postpartum

Population: 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.

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?"

Outcome measures

Outcome measures
Measure	Combined Spinal Epidural (CSE) n=2 Participants 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 n=2 Participants 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
Pain Score on Average (BPI - Short Form)	4.50 score on a scale Standard Deviation 2.12	2.00 score on a scale Standard Deviation 2.83

SECONDARY outcome

Timeframe: 2 days postpartum

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

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

Outcome measures

Outcome measures
Measure	Combined Spinal Epidural (CSE) n=25 Participants 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 n=28 Participants 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
Perceived Stress (PSS)	13.08 score on a scale Standard Deviation 6.80	12.39 score on a scale Standard Deviation 5.55

SECONDARY outcome

Timeframe: 2 Days Postpartum

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

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

Outcome measures

Outcome measures
Measure	Combined Spinal Epidural (CSE) n=25 Participants 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 n=28 Participants 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
Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No)	22 Participants	18 Participants

SECONDARY outcome

Timeframe: 6 weeks postpartum

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

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

Outcome measures

Outcome measures
Measure	Combined Spinal Epidural (CSE) n=20 Participants 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 n=24 Participants 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
Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No)	15 Participants	12 Participants

SECONDARY outcome

Timeframe: 3 months postpartum

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

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

Outcome measures

Outcome measures
Measure	Combined Spinal Epidural (CSE) n=15 Participants 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 n=23 Participants 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
Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No)	9 Participants	8 Participants

SECONDARY outcome

Timeframe: 6 weeks postpartum

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

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

Outcome measures

Outcome measures
Measure	Combined Spinal Epidural (CSE) n=22 Participants 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 n=24 Participants 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
Parent-Infant Attachment (MPAS)	84.09 score on a scale Standard Deviation 5.48	87.68 score on a scale Standard Deviation 5.55

SECONDARY outcome

Timeframe: 3 months postpartum

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

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

Outcome measures

Outcome measures
Measure	Combined Spinal Epidural (CSE) n=15 Participants 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 n=23 Participants 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
Parent-Infant Attachment (MPAS)	88.08 score on a scale Standard Deviation 4.01	88.70 score on a scale Standard Deviation 4.78

SECONDARY outcome

Timeframe: 6 weeks postpartum

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

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

Outcome measures

Outcome measures
Measure	Combined Spinal Epidural (CSE) n=22 Participants 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 n=24 Participants 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
Child Development (ASQ-3) Personal Social Score	43.64 score on a scale Standard Deviation 11.15	46.04 score on a scale Standard Deviation 10.21

SECONDARY outcome

Timeframe: 3 months postpartum

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

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

Outcome measures

Outcome measures
Measure	Combined Spinal Epidural (CSE) n=15 Participants 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 n=23 Participants 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
Child Development (ASQ-3) Personal Social Score	45.00 score on a scale Standard Deviation 14.85	47.33 score on a scale Standard Deviation 10.33

SECONDARY outcome

Timeframe: 6 weeks postpartum

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

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

Outcome measures

Outcome measures
Measure	Combined Spinal Epidural (CSE) n=22 Participants 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 n=24 Participants 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
Parenting Self-efficacy (PMP-SE)	71.45 score on a scale Standard Deviation 6.54	71.92 score on a scale Standard Deviation 5.82

SECONDARY outcome

Timeframe: 3 months postpartum

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

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

Outcome measures

Outcome measures
Measure	Combined Spinal Epidural (CSE) n=15 Participants 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 n=23 Participants 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
Parenting Self-Efficacy (PMP-SE)	73.20 score on a scale Standard Deviation 5.92	74.48 score on a scale Standard Deviation 6.47

SECONDARY outcome

Timeframe: 3 months

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

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.

Outcome measures

Outcome measures
Measure	Combined Spinal Epidural (CSE) n=15 Participants 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 n=23 Participants 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
Edinburgh Postnatal Depression Score (EPDS)	3.53 score on a scale Standard Deviation 3.93	3.96 score on a scale Standard Deviation 3.67

Adverse Events

Combined Spinal Epidural (CSE)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Epidural

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Grace Lim

University of Pittsburgh

Phone: 412-641-2179

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place