Depression, Postpartum, Labor Pain
Conditions
Keywords
Pregnant, Analgesia, Labor analgesia, Epidural, Combined spinal epidural
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.
Interventions
Sponsors
Grace Lim, MD, MS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress (PSS) | 2 days postpartum | Self-completed questionnaire, electronically completed. Scores range from 0-40, with higher scores indicating higher perceived stress. |
| 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. |
| 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. |
| 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. |
| 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? |
| 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. |
| 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. |
| 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. |
| 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. |
| Parent-Infant Attachment (MPAS) | 6 weeks postpartum | Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 31 |
| 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 | 30 |
| Total | 61 |
Baseline characteristics
| Characteristic | Combined Spinal Epidural (CSE) | Total | Epidural |
|---|---|---|---|
| Age, Continuous | 27.36 years STANDARD_DEVIATION 4.64 | 27.46 years STANDARD_DEVIATION 5.37 | 27.56 years STANDARD_DEVIATION 6.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 59 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 41 Participants | 21 Participants |
| Region of Enrollment United States | 31 participants | 61 participants | 30 participants |
| Sex: Female, Male Female | 31 Participants | 61 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 0 / 31 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 |
Outcome results
Primary
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.
Time frame: 6 weeks
Population: Included all participants who completed electronically administered EPDS at the 6 week timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Spinal Epidural (CSE) | Edinburgh Postnatal Depression Score (EPDS) | 4.23 score on a scale | Standard Deviation 3.93 |
| Epidural | Edinburgh Postnatal Depression Score (EPDS) | 4.71 score on a scale | Standard Deviation 5.82 |
p-value: 0.7463t-test, 2 sided
Secondary
Child Development (ASQ-3) Personal Social Score
Self-completed questionnaire, electronically completed. Scores range from 0-60, with higher scores indicating higher personal-social development.
Time frame: 6 weeks postpartum
Population: This population includes all participants who completed the electronically administered ASQ at the 6 week timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Spinal Epidural (CSE) | Child Development (ASQ-3) Personal Social Score | 43.64 score on a scale | Standard Deviation 11.15 |
| Epidural | Child Development (ASQ-3) Personal Social Score | 46.04 score on a scale | Standard Deviation 10.21 |
p-value: 0.449t-test, 2 sided
Secondary
Child Development (ASQ-3) Personal Social Score
Self-completed questionnaire, electronically completed. Scores range from 0-60, with higher scores indicating higher personal-social development.
Time frame: 3 months postpartum
Population: This population includes all participants who completed the electronically administered ASQ at the 3 month timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Spinal Epidural (CSE) | Child Development (ASQ-3) Personal Social Score | 45.00 score on a scale | Standard Deviation 14.85 |
| Epidural | Child Development (ASQ-3) Personal Social Score | 47.33 score on a scale | Standard Deviation 10.33 |
p-value: 0.5996t-test, 2 sided
Secondary
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.
Time frame: 3 months
Population: This population includes all participants who completed the electronically administered EPDS at the 3 month timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Spinal Epidural (CSE) | Edinburgh Postnatal Depression Score (EPDS) | 3.53 score on a scale | Standard Deviation 3.93 |
| Epidural | Edinburgh Postnatal Depression Score (EPDS) | 3.96 score on a scale | Standard Deviation 3.67 |
p-value: 0.7374t-test, 2 sided
Secondary
Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No)
Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.
Time frame: 2 Days Postpartum
Population: This population includes all participants who completed the electronically administered breastfeeding form at the postpartum day 2 timepoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Spinal Epidural (CSE) | Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No) | 22 Participants |
| Epidural | Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No) | 18 Participants |
p-value: 0.0452Chi-squared
Secondary
Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No)
Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.
Time frame: 3 months postpartum
Population: This population includes all participants who completed the electronically administered breastfeeding form at the 3 month timepoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Spinal Epidural (CSE) | Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No) | 9 Participants |
| Epidural | Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No) | 8 Participants |
p-value: 0.1265Chi-squared
Secondary
Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No)
Self-completed questionnaire, electronically completed. Results represent the percentage of each arm currently breastfeeding at this time point.
Time frame: 6 weeks postpartum
Population: This population includes all participants who completed the electronically administered breastfeeding form at the 6 week timepoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Spinal Epidural (CSE) | Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No) | 15 Participants |
| Epidural | Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No) | 12 Participants |
p-value: 0.0899Chi-squared
Secondary
Pain Score on Average (BPI - Short Form)
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Spinal Epidural (CSE) | Pain Score on Average (BPI - Short Form) | 4.50 score on a scale | Standard Deviation 2.12 |
| Epidural | Pain Score on Average (BPI - Short Form) | 2.00 score on a scale | Standard Deviation 2.83 |
p-value: 0.4226t-test, 2 sided
Secondary
Pain Score on Average (BPI - Short Form)
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Spinal Epidural (CSE) | Pain Score on Average (BPI - Short Form) | 3.00 score on a scale | Standard Deviation 2.35 |
| Epidural | Pain Score on Average (BPI - Short Form) | 4.00 score on a scale | Standard Deviation 0 |
p-value: 0.7169t-test, 2 sided
Secondary
Pain Score on Average (BPI - Short Form)
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Spinal Epidural (CSE) | Pain Score on Average (BPI - Short Form) | 4.64 score on a scale | Standard Deviation 2.13 |
| Epidural | Pain Score on Average (BPI - Short Form) | 4.19 score on a scale | Standard Deviation 2.26 |
p-value: 0.5764t-test, 2 sided
Secondary
Parent-Infant Attachment (MPAS)
Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.
Time frame: 3 months postpartum
Population: This population includes all participants who completed the electronically administered MPAS at the 3 month timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Spinal Epidural (CSE) | Parent-Infant Attachment (MPAS) | 88.08 score on a scale | Standard Deviation 4.01 |
| Epidural | Parent-Infant Attachment (MPAS) | 88.70 score on a scale | Standard Deviation 4.78 |
p-value: 0.6824t-test, 2 sided
Secondary
Parent-Infant Attachment (MPAS)
Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.
Time frame: 6 weeks postpartum
Population: This population includes all participants who completed the electronically administered MPAS at the 6 week timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Spinal Epidural (CSE) | Parent-Infant Attachment (MPAS) | 84.09 score on a scale | Standard Deviation 5.48 |
| Epidural | Parent-Infant Attachment (MPAS) | 87.68 score on a scale | Standard Deviation 5.55 |
p-value: 0.0328t-test, 2 sided
Secondary
Parenting Self-efficacy (PMP-SE)
Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy.
Time frame: 6 weeks postpartum
Population: This population includes all participants who completed the electronically administered PMP-SE at the 6 week timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Spinal Epidural (CSE) | Parenting Self-efficacy (PMP-SE) | 71.45 score on a scale | Standard Deviation 6.54 |
| Epidural | Parenting Self-efficacy (PMP-SE) | 71.92 score on a scale | Standard Deviation 5.82 |
p-value: 0.8009t-test, 2 sided
Secondary
Parenting Self-Efficacy (PMP-SE)
Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy.
Time frame: 3 months postpartum
Population: This population includes all participants who completed the electronically administered PMP-SE at the 3 month timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Spinal Epidural (CSE) | Parenting Self-Efficacy (PMP-SE) | 73.20 score on a scale | Standard Deviation 5.92 |
| Epidural | Parenting Self-Efficacy (PMP-SE) | 74.48 score on a scale | Standard Deviation 6.47 |
p-value: 0.5422t-test, 2 sided
Secondary
Perceived Stress (PSS)
Self-completed questionnaire, electronically completed. Scores range from 0-40, with higher scores indicating higher perceived stress.
Time frame: 2 days postpartum
Population: This population includes all participants who completed the electronically administered PSS at the postpartum day 2 timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Spinal Epidural (CSE) | Perceived Stress (PSS) | 13.08 score on a scale | Standard Deviation 6.8 |
| Epidural | Perceived Stress (PSS) | 12.39 score on a scale | Standard Deviation 5.55 |
p-value: 0.6873t-test, 2 sided