CompletedNCT03022526COPEUpdated Aug 19, 2020Results posted

CSE v. Epidural for Postpartum Depression

An interventional study of CSE and Epidural in Depression, Postpartum and Labor Pain, sponsored by Grace Lim, MD, MS. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-19.

Sponsored by Grace Lim, MD, MS · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 61
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: Female

Study 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.

Conditions studied

Depression, Postpartum
Labor Pain

Browse trials for

Keywords

Pregnant
Analgesia
Labor analgesia
Epidural
Combined spinal epidural

In context

Depression, Postpartum

528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.

This study's enrollment of 61 is below the median of 105 across 425 interventional studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

Grace Lim, MD, MS is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: 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

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

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 61 participants (actual)

Study arms

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

Interventions

ProcedureCSE
ProcedureEpidural
DrugBupivacaine / fentaNYL

What researchers measure

Primary outcomes

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

Secondary outcomes

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
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
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
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
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
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
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
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
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
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
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
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
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
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

Results

Posted Aug 10, 2020

Participant flow

Participant flow — Overall Study
Milestone	Combined Spinal Epidural (CSE)	Epidural
Started	31	30
Completed	21	25
Not completed	10	5

Outcome measures

PrimaryEdinburgh 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
Reported as:: Mean · score on a scale

Edinburgh Postnatal Depression Score (EPDS)
score on a scale	Combined Spinal Epidural (CSE)	Epidural
Edinburgh Postnatal Depression Score (EPDS)	4.23 ± 3.93	4.71 ± 5.82

Statistical analysis

Combined Spinal Epidural (CSE) vs Epidural · t-test, 2 sided · p = 0.7463

SecondaryPain 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
Reported as:: Mean · score on a scale

Pain Score on Average (BPI - Short Form)
score on a scale	Combined Spinal Epidural (CSE)	Epidural
Pain Score on Average (BPI - Short Form)	4.64 ± 2.13	4.19 ± 2.26

Statistical analysis

Combined Spinal Epidural (CSE) vs Epidural · t-test, 2 sided · p = 0.5764

SecondaryPain Score on Average (BPI - Short Form)

Time frame:: 6 weeks postpartum
Reported as:: Mean · score on a scale

Pain Score on Average (BPI - Short Form)
score on a scale	Combined Spinal Epidural (CSE)	Epidural
Pain Score on Average (BPI - Short Form)	3.00 ± 2.35	4.00 ± 0.00

Statistical analysis

Combined Spinal Epidural (CSE) vs Epidural · t-test, 2 sided · p = 0.7169

SecondaryPain Score on Average (BPI - Short Form)

Time frame:: 3 months postpartum
Reported as:: Mean · score on a scale

Pain Score on Average (BPI - Short Form)
score on a scale	Combined Spinal Epidural (CSE)	Epidural
Pain Score on Average (BPI - Short Form)	4.50 ± 2.12	2.00 ± 2.83

Statistical analysis

Combined Spinal Epidural (CSE) vs Epidural · t-test, 2 sided · p = 0.4226

SecondaryPerceived Stress (PSS)

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

Time frame:: 2 days postpartum
Reported as:: Mean · score on a scale

Perceived Stress (PSS)
score on a scale	Combined Spinal Epidural (CSE)	Epidural
Perceived Stress (PSS)	13.08 ± 6.80	12.39 ± 5.55

Statistical analysis

Combined Spinal Epidural (CSE) vs Epidural · t-test, 2 sided · p = 0.6873

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No)
Participants	Combined Spinal Epidural (CSE)	Epidural
Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No)	22	18

Statistical analysis

Combined Spinal Epidural (CSE) vs Epidural · Chi-squared · p = 0.0452

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No)
Participants	Combined Spinal Epidural (CSE)	Epidural
Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No)	15	12

Statistical analysis

Combined Spinal Epidural (CSE) vs Epidural · Chi-squared · p = 0.0899

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No)
Participants	Combined Spinal Epidural (CSE)	Epidural
Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No)	9	8

Statistical analysis

Combined Spinal Epidural (CSE) vs Epidural · Chi-squared · p = 0.1265

SecondaryParent-Infant Attachment (MPAS)

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

Time frame:: 6 weeks postpartum
Reported as:: Mean · score on a scale

Parent-Infant Attachment (MPAS)
score on a scale	Combined Spinal Epidural (CSE)	Epidural
Parent-Infant Attachment (MPAS)	84.09 ± 5.48	87.68 ± 5.55

Statistical analysis

Combined Spinal Epidural (CSE) vs Epidural · t-test, 2 sided · p = 0.0328

SecondaryParent-Infant Attachment (MPAS)

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

Time frame:: 3 months postpartum
Reported as:: Mean · score on a scale

Parent-Infant Attachment (MPAS)
score on a scale	Combined Spinal Epidural (CSE)	Epidural
Parent-Infant Attachment (MPAS)	88.08 ± 4.01	88.70 ± 4.78

Statistical analysis

Combined Spinal Epidural (CSE) vs Epidural · t-test, 2 sided · p = 0.6824

SecondaryChild 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
Reported as:: Mean · score on a scale

Child Development (ASQ-3) Personal Social Score
score on a scale	Combined Spinal Epidural (CSE)	Epidural
Child Development (ASQ-3) Personal Social Score	43.64 ± 11.15	46.04 ± 10.21

Statistical analysis

Combined Spinal Epidural (CSE) vs Epidural · t-test, 2 sided · p = 0.449

SecondaryChild 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
Reported as:: Mean · score on a scale

Child Development (ASQ-3) Personal Social Score
score on a scale	Combined Spinal Epidural (CSE)	Epidural
Child Development (ASQ-3) Personal Social Score	45.00 ± 14.85	47.33 ± 10.33

Statistical analysis

Combined Spinal Epidural (CSE) vs Epidural · t-test, 2 sided · p = 0.5996

SecondaryParenting 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
Reported as:: Mean · score on a scale

Parenting Self-efficacy (PMP-SE)
score on a scale	Combined Spinal Epidural (CSE)	Epidural
Parenting Self-efficacy (PMP-SE)	71.45 ± 6.54	71.92 ± 5.82

Statistical analysis

Combined Spinal Epidural (CSE) vs Epidural · t-test, 2 sided · p = 0.8009

SecondaryParenting 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
Reported as:: Mean · score on a scale

Parenting Self-Efficacy (PMP-SE)
score on a scale	Combined Spinal Epidural (CSE)	Epidural
Parenting Self-Efficacy (PMP-SE)	73.20 ± 5.92	74.48 ± 6.47

Statistical analysis

Combined Spinal Epidural (CSE) vs Epidural · t-test, 2 sided · p = 0.5422

SecondaryEdinburgh Postnatal Depression Score (EPDS)

Time frame:: 3 months
Reported as:: Mean · score on a scale

Edinburgh Postnatal Depression Score (EPDS)
score on a scale	Combined Spinal Epidural (CSE)	Epidural
Edinburgh Postnatal Depression Score (EPDS)	3.53 ± 3.93	3.96 ± 3.67

Statistical analysis

Combined Spinal Epidural (CSE) vs Epidural · t-test, 2 sided · p = 0.7374

Adverse events

Collected over 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).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Combined Spinal Epidural (CSE)	0/31 (0%)	0/31 (0%)	0/31 (0%)
Epidural	0/30 (0%)	0/30 (0%)	0/30 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Combined Spinal Epidural (CSE)	Epidural	Total
Mean	27.36 ± 4.64	27.56 ± 6.05	27.46 ± 5.37

Sex: Female, Male
Sex: Female, Male(Participants)	Combined Spinal Epidural (CSE)	Epidural	Total
Female	31	30	61
Male	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Combined Spinal Epidural (CSE)	Epidural	Total
Hispanic or Latino	0	2	2
Not Hispanic or Latino	31	28	59
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Combined Spinal Epidural (CSE)	Epidural	Total
American Indian or Alaska Native	0	1	1
Asian	3	0	3
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	5	6	11
White	20	21	41
More than one race	2	2	4
Unknown or Not Reported	1	0	1

Region of Enrollment
Region of Enrollment(participants)	Combined Spinal Epidural (CSE)	Epidural	Total
United States	31	30	61

Study locations

1 site

Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania 15213, United States

References and documents

Publications

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. PubMed 18401329 ↗
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. PubMed 23487258 ↗
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. doi: 10.1111/j.1552-6909.2006.00087.x. PubMed 16958723 ↗
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. PubMed 24797120 ↗
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. doi: 10.1016/j.genhosppsych.2004.02.006. PubMed 15234824 ↗
Righetti-Veltema M, Conne-Perreard E, Bousquet A, Manzano J. Risk factors and predictive signs of postpartum depression. J Affect Disord. 1998 Jun;49(3):167-80. doi: 10.1016/s0165-0327(97)00110-9. PubMed 9629946 ↗
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. PubMed 24140480 ↗
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
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. doi: 10.1023/a:1021110100339. PubMed 12512766 ↗
O'Hara M, Swain A. Rates and risk of postpartum depression-A meta-analysis. Int Rev Psychiatry. 1996;8:37-54
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. doi: 10.1016/j.jadohealth.2005.05.023. PubMed 16730600 ↗
Hirst KP, Moutier CY. Postpartum major depression. Am Fam Physician. 2010 Oct 15;82(8):926-33. PubMed 20949886 ↗
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. PubMed 19318144 ↗
Lindahl V, Pearson JL, Colpe L. Prevalence of suicidality during pregnancy and the postpartum. Arch Womens Ment Health. 2005 Jun;8(2):77-87. doi: 10.1007/s00737-005-0080-1. Epub 2005 May 11. PubMed 15883651 ↗
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. PubMed 22215285 ↗
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. PubMed 21515195 ↗
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. PubMed 24108418 ↗
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. No abstract available. PubMed 6384895 ↗
Boudou M, Teissedre 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. doi: 10.1016/j.encep.2006.10.002. French. PubMed 18357852 ↗
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. PubMed 18818022 ↗
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. doi: 10.1111/j.0001-6349.2004.0302.x. PubMed 14995921 ↗
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. PubMed 20121831 ↗
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. PubMed 20605900 ↗
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. PubMed 23723741 ↗
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. PubMed 25269760 ↗

Study documents

Protocol and statistical analysis plan · Jul 15, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03022526
Lead sponsor: Grace Lim, MD, MS
Responsible party: Grace Lim, MD, MS (Assistant Professor of Anesthesiology, University of Pittsburgh) — Sponsor-investigator
First posted: Jan 16, 2017
Start date: Jan 2017
Primary completion: Dec 31, 2019
Completion: Dec 31, 2019
Results posted: Aug 10, 2020
Last update: Aug 19, 2020

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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CSE v. Epidural for Postpartum Depression

Study summary

Conditions studied

Browse trials for

Keywords

In context

Depression, Postpartum

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Study documents

Individual participant data

Updates

Registry details

Key details

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria