Depression, PostpartumCOPENCT03022526

CSE v. Epidural for Postpartum Depression

A study testing CSE, Epidural and Bupivacaine / fentaNYL in people with Depression, Postpartum and Labor Pain, run by Grace Lim, MD, MS at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Depression, Postpartum, Labor Pain
What is being tested?: CSE, Epidural and Bupivacaine / fentaNYL
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteUnited States
Study dates: Jan 2017to 31 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Combined Spinal Epidural v. Epidural Labor Analgesia for Postpartum Depression Symptoms (COPE Trial): Pilot Randomized Control Trial

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: Depression, Postpartum, Labor Pain
Being tested: CSE, Epidural, Bupivacaine / fentaNYL
Keywords: Pregnant, Analgesia, Labor analgesia, Epidural, Combined spinal epidural
Medical subject headings: Depression, Postpartum, Labor Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CSEProcedure or surgery
EpiduralProcedure or surgery
Bupivacaine / fentaNYLDrug

Study groups in NCT03022526
Study group	Role	What they receive
CSE	Experimental	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 Receives: Procedure: CSE; Drug: Bupivacaine / fentaNYL
Epidural	Active comparator	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 Receives: Procedure: Epidural; Drug: Bupivacaine / fentaNYL

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 weeks

Secondary outcomes (14)

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?"
Measured: 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?"
Measured: 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?"
Measured: 3 months postpartum
Perceived Stress (PSS)
Self-completed questionnaire, electronically completed. Scores range from 0-40, with higher scores indicating higher perceived stress.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months postpartum
Parent-Infant Attachment (MPAS)
Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.
Measured: 6 weeks postpartum
Parent-Infant Attachment (MPAS)
Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201731 Dec 2019

First posted16 Jan 2017 (estimated)
Study startJan 2017
Primary completion31 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Depression, PostpartumStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03022526
Sponsor's protocol ID: PRO16060602
Acronym: COPE
Status last verified: Aug 2020
First submitted: 11 Jan 2017
Last updated: 19 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combined Spinal Epidural v. Epidural Labor Analgesia for Postpartum Depression Symptoms (COPE Trial): Pilot Randomized Control Trial
ClinicalTrials.gov ID: NCT03022526
Acronym / sponsor ID: COPE / PRO16060602
Conditions: Depression, Postpartum, Labor Pain
Keywords: Pregnant, Analgesia, Labor analgesia, Epidural, Combined spinal epidural
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Grace Lim, MD, MSUniversity, hospital or other
Study start: Jan 2017
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 16 Jan 2017 (estimated)
Results: Posted 10 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CSE	Experimental	Procedure: CSE, Drug: Bupivacaine / fentaNYLintrathecal 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
Epidural	Active comparator	Procedure: Epidural, Drug: Bupivacaine / fentaNYLepidural 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

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Nulliparous (no prior childbirth)
Singleton gestation
Third trimester
Healthy pregnancy
English proficiency (surveys validated in English)

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CSE	Procedure or surgery	CSE
Epidural	Procedure or surgery	Epidural
Bupivacaine / fentaNYL	Drug	CSE, Epidural

Primary outcome

Edinburgh Postnatal Depression Score (EPDS)
Time frame: 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.

14 secondary outcomes

Pain Score on Average (BPI - Short Form)
Time frame: 2 days postpartum
Pain Score on Average (BPI - Short Form)
Time frame: 6 weeks postpartum
Pain Score on Average (BPI - Short Form)
Time frame: 3 months postpartum
Perceived Stress (PSS)
Time frame: 2 days postpartum
Number of Participants Currently Breastfeeding at 2 Days Postpartum (Yes/No)
Time frame: 2 Days Postpartum
Number of Participants Currently Breastfeeding at 6 Weeks Postpartum (Yes/No)
Time frame: 6 weeks postpartum
Number of Participants Currently Breastfeeding at 3 Months Postpartum (Yes/No)
Time frame: 3 months postpartum
Parent-Infant Attachment (MPAS)
Time frame: 6 weeks postpartum
Parent-Infant Attachment (MPAS)
Time frame: 3 months postpartum
Child Development (ASQ-3) Personal Social Score
Time frame: 6 weeks postpartum
Child Development (ASQ-3) Personal Social Score
Time frame: 3 months postpartum
Parenting Self-efficacy (PMP-SE)
Time frame: 6 weeks postpartum
Parenting Self-Efficacy (PMP-SE)
Time frame: 3 months postpartum
Edinburgh Postnatal Depression Score (EPDS)
Time frame: 3 months

Results and safety

Results posted to the registry on 10 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Combined Spinal Epidural (CSE)	31	21
Epidural	30	25

Primary outcome: Edinburgh Postnatal Depression Score (EPDS)

Time frame: 6 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Combined Spinal Epidural (CSE) n = 22	Epidural n = 24
Value	4.23 (3.93)	4.71 (5.82)

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

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

14 secondary outcomes are reported in the full results.

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).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Combined Spinal Epidural (CSE)	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Epidural	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18401329Centers 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.
Background: PubMed 23487258Wisner 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.
Background: PubMed 16958723Logsdon 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.
Background: PubMed 24797120Ding 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.
Background: PubMed 15234824Robertson 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.
Background: PubMed 9629946Righetti-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.
Background: PubMed 24140480O'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.
BackgroundChapman 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
Background: PubMed 12512766Gross 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.
BackgroundO'Hara M, Swain A. Rates and risk of postpartum depression-A meta-analysis. Int Rev Psychiatry. 1996;8:37-54
Background: PubMed 16730600Schmidt 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.
Background: PubMed 20949886Hirst KP, Moutier CY. Postpartum major depression. Am Fam Physician. 2010 Oct 15;82(8):926-33.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CSE, Epidural and Bupivacaine / fentaNYL in people with Depression, Postpartum and Labor Pain, run by Grace Lim, MD, MS at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Edinburgh Postnatal Depression Score (EPDS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03022526, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.