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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSE | Procedure |
| ||
| Epidural |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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?" | 2 days postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18401329 | Background | 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. | |
| 23487258 | Background | 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. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Epidural |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Included all participants who completed electronically administered EPDS at the 6 week timepoint. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grace Lim | University of Pittsburgh | 412-641-2179 | limkg2@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2020 | Jul 15, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D048949 | Labor Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007268 | Injections, Epidural |
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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|
| Bupivacaine / fentaNYL | Drug |
|
| 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?" |
| 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?" | 3 months postpartum |
| Perceived Stress (PSS) | Self-completed questionnaire, electronically completed. Scores range from 0-40, with higher scores indicating higher perceived stress. | 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. | 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. | 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. | 3 months postpartum |
| Parent-Infant Attachment (MPAS) | Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment. | 6 weeks postpartum |
| Parent-Infant Attachment (MPAS) | Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment. | 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. | 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. | 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. | 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. | 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. | 3 months |
| 16958723 | Background | 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. |
| 24797120 | Background | 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. |
| 15234824 | Background | 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. |
| 9629946 | Background | 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. |
| 24140480 | Background | 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. |
| Background | 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 |
| 12512766 | Background | 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. |
| Background | O'Hara M, Swain A. Rates and risk of postpartum depression-A meta-analysis. Int Rev Psychiatry. 1996;8:37-54 |
| 16730600 | Background | 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. |
| 20949886 | Background | Hirst KP, Moutier CY. Postpartum major depression. Am Fam Physician. 2010 Oct 15;82(8):926-33. |
| 19318144 | Background | 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. |
| 15883651 | Background | 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. |
| 22215285 | Background | 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. |
| 21515195 | Background | 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. |
| 24108418 | Background | 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. |
| 6384895 | Background | 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. |
| 18357852 | Background | 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. |
| 18818022 | Background | 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. |
| 14995921 | Background | 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. |
| 20121831 | Background | 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. |
| 20605900 | Background | 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. |
| 23723741 | Background | 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. |
| 25269760 | Background | 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. |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 |
|
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|
| 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?" | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 days postpartum |
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| 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?" | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks postpartum |
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| 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?" | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months postpartum |
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| Secondary | Perceived Stress (PSS) | Self-completed questionnaire, electronically completed. Scores range from 0-40, with higher scores indicating higher perceived stress. | This population includes all participants who completed the electronically administered PSS at the postpartum day 2 timepoint. | Posted | Mean | Standard Deviation | score on a scale | 2 days postpartum |
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| 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. | This population includes all participants who completed the electronically administered breastfeeding form at the postpartum day 2 timepoint. | Posted | Count of Participants | Participants | 2 Days Postpartum |
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| 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. | This population includes all participants who completed the electronically administered breastfeeding form at the 6 week timepoint. | Posted | Count of Participants | Participants | 6 weeks postpartum |
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| 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. | This population includes all participants who completed the electronically administered breastfeeding form at the 3 month timepoint. | Posted | Count of Participants | Participants | 3 months postpartum |
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| Secondary | Parent-Infant Attachment (MPAS) | Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment. | This population includes all participants who completed the electronically administered MPAS at the 6 week timepoint. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks postpartum |
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| Secondary | Parent-Infant Attachment (MPAS) | Self-completed questionnaire, electronically completed. Scores range from 19-95, with higher scores indicating higher attachment. | This population includes all participants who completed the electronically administered MPAS at the 3 month timepoint. | Posted | Mean | Standard Deviation | score on a scale | 3 months postpartum |
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| 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. | This population includes all participants who completed the electronically administered ASQ at the 6 week timepoint. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks postpartum |
|
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| 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. | This population includes all participants who completed the electronically administered ASQ at the 3 month timepoint. | Posted | Mean | Standard Deviation | score on a scale | 3 months postpartum |
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| Secondary | Parenting Self-efficacy (PMP-SE) | Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy. | This population includes all participants who completed the electronically administered PMP-SE at the 6 week timepoint. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks postpartum |
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| Secondary | Parenting Self-Efficacy (PMP-SE) | Self-completed questionnaire, electronically completed. Scores range from 20-80, with higher scores indicating higher parenting self-efficacy. | This population includes all participants who completed the electronically administered PMP-SE at the 3 month timepoint. | Posted | Mean | Standard Deviation | score on a scale | 3 months postpartum |
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| 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. | This population includes all participants who completed the electronically administered EPDS at the 3 month timepoint. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
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| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | 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 | 0 | 30 | 0 | 30 | 0 | 30 |
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| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D013812 |
| Therapeutics |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |