Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-02-04 @ 6:20 AM
Study NCT ID:
NCT02692404
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2016-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Labor Pain and Postpartum Behavioral Health Outcomes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D048949', 'term': 'Labor Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva samples for DNA extraction'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-15', 'studyFirstSubmitDate': '2016-02-17', 'studyFirstSubmitQcDate': '2016-02-22', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Edinburgh Postnatal Depression Score (EPDS)', 'timeFrame': 'Postpartum Week 6'}], 'secondaryOutcomes': [{'measure': 'Perceived Stress', 'timeFrame': 'Postpartum Day 1 or 2'}, {'measure': 'Brief Pain Inventory', 'timeFrame': 'Postpartum Day 1 or 2, 6 weeks, and 3 months'}, {'measure': 'Maternal-Infant Attachment', 'timeFrame': 'Postpartum Week 6, and 3 months'}, {'measure': 'Parenting Self-Efficacy', 'timeFrame': 'Postpartum Week 6, and 3 months'}, {'measure': 'Child Development', 'timeFrame': 'Postpartum Week 6, and 3 months'}, {'measure': 'Edinburgh Postnatal Depression Score (EPDS)', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postpartum Depression', 'Perinatal Depression', 'Pregnancy', 'Anesthesia', 'Obstetric', 'Pain', 'Analgesia', 'Epidural', 'Midwife', 'Infant Development', 'Pain Management'], 'conditions': ['Depression, Postpartum', 'Pregnancy', 'Child Development', 'Pain', 'Labor Pain']}, 'referencesModule': {'references': [{'pmid': '12512766', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16730600', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18401329', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19318144', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20949886', 'type': 'BACKGROUND', 'citation': 'Hirst KP, Moutier CY. Postpartum major depression. Am Fam Physician. 2010 Oct 15;82(8):926-33.'}, {'pmid': '23487258', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15883651', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22215285', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21515195', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24108418', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '18357852', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23249931', 'type': 'BACKGROUND', 'citation': "Eisenach JC, Pan P, Smiley RM, Lavand'homme P, Landau R, Houle TT. Resolution of pain after childbirth. Anesthesiology. 2013 Jan;118(1):143-51. doi: 10.1097/ALN.0b013e318278ccfd."}, {'pmid': '24797120', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '14995921', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25046776', 'type': 'BACKGROUND', 'citation': 'Wisner KL, Stika CS, Clark CT. Double duty: does epidural labor analgesia reduce both pain and postpartum depression? Anesth Analg. 2014 Aug;119(2):219-221. doi: 10.1213/ANE.0000000000000322. No abstract available.'}, {'pmid': '25229827', 'type': 'BACKGROUND', 'citation': 'Eapen V, Dadds M, Barnett B, Kohlhoff J, Khan F, Radom N, Silove DM. Separation anxiety, attachment and inter-personal representations: disentangling the role of oxytocin in the perinatal period. PLoS One. 2014 Sep 17;9(9):e107745. doi: 10.1371/journal.pone.0107745. eCollection 2014.'}, {'pmid': '19336362', 'type': 'BACKGROUND', 'citation': 'Dennis CL, McQueen K. The relationship between infant-feeding outcomes and postpartum depression: a qualitative systematic review. Pediatrics. 2009 Apr;123(4):e736-51. doi: 10.1542/peds.2008-1629.'}, {'pmid': '20861420', 'type': 'BACKGROUND', 'citation': 'Segal S. Labor epidural analgesia and maternal fever. Anesth Analg. 2010 Dec;111(6):1467-75. doi: 10.1213/ANE.0b013e3181f713d4. Epub 2010 Sep 22.'}, {'pmid': '10739529', 'type': 'BACKGROUND', 'citation': 'Yoon BH, Romero R, Park JS, Kim CJ, Kim SH, Choi JH, Han TR. Fetal exposure to an intra-amniotic inflammation and the development of cerebral palsy at the age of three years. Am J Obstet Gynecol. 2000 Mar;182(3):675-81. doi: 10.1067/mob.2000.104207.'}, {'pmid': '11426893', 'type': 'BACKGROUND', 'citation': 'Impey L, Greenwood C, MacQuillan K, Reynolds M, Sheil O. Fever in labour and neonatal encephalopathy: a prospective cohort study. BJOG. 2001 Jun;108(6):594-7. doi: 10.1111/j.1471-0528.2001.00145.x.'}, {'pmid': '18166304', 'type': 'BACKGROUND', 'citation': 'Impey LW, Greenwood CE, Black RS, Yeh PS, Sheil O, Doyle P. The relationship between intrapartum maternal fever and neonatal acidosis as risk factors for neonatal encephalopathy. Am J Obstet Gynecol. 2008 Jan;198(1):49.e1-6. doi: 10.1016/j.ajog.2007.06.011.'}, {'pmid': '24058502', 'type': 'BACKGROUND', 'citation': 'Pinto PR, McIntyre T, Ferrero R, Almeida A, Araujo-Soares V. Risk factors for moderate and severe persistent pain in patients undergoing total knee and hip arthroplasty: a prospective predictive study. PLoS One. 2013 Sep 13;8(9):e73917. doi: 10.1371/journal.pone.0073917. eCollection 2013.'}, {'pmid': '24552601', 'type': 'BACKGROUND', 'citation': 'Ravindran D. Chronic postsurgical pain: prevention and management. J Pain Palliat Care Pharmacother. 2014 Mar;28(1):51-3. doi: 10.3109/15360288.2013.879249. Epub 2014 Feb 19.'}, {'pmid': '22406985', 'type': 'BACKGROUND', 'citation': 'Quinlan J, Carter K. Acute pain management in patients with persistent pain. Curr Opin Support Palliat Care. 2012 Jun;6(2):188-93. doi: 10.1097/SPC.0b013e3283520fb6.'}, {'pmid': '25766270', 'type': 'BACKGROUND', 'citation': 'Pandolfo G, Gugliandolo A, Gangemi C, Arrigo R, Curro M, La Ciura G, Muscatello MR, Bruno A, Zoccali R, Caccamo D. Association of the COMT synonymous polymorphism Leu136Leu and missense variant Val158Met with mood disorders. J Affect Disord. 2015 May 15;177:108-13. doi: 10.1016/j.jad.2015.02.016. Epub 2015 Feb 25.'}, {'pmid': '3651732', 'type': 'BACKGROUND', 'citation': 'Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.'}, {'pmid': '11972140', 'type': 'BACKGROUND', 'citation': 'Boudarene M, Legros JJ, Timsit-Berthier M. [Study of the stress response: role of anxiety, cortisol and DHEAs]. Encephale. 2002 Mar-Apr;28(2):139-46. French.'}, {'pmid': '20562010', 'type': 'BACKGROUND', 'citation': 'Wemm S, Koone T, Blough ER, Mewaldt S, Bardi M. The role of DHEA in relation to problem solving and academic performance. Biol Psychol. 2010 Sep;85(1):53-61. doi: 10.1016/j.biopsycho.2010.05.003. Epub 2010 May 26.'}, {'pmid': '19141305', 'type': 'BACKGROUND', 'citation': 'Shirotsuki K, Izawa S, Sugaya N, Yamada KC, Ogawa N, Ouchi Y, Nagano Y, Nomura S. Salivary cortisol and DHEA reactivity to psychosocial stress in socially anxious males. Int J Psychophysiol. 2009 May;72(2):198-203. doi: 10.1016/j.ijpsycho.2008.12.010. Epub 2008 Dec 24.'}, {'pmid': '22405670', 'type': 'BACKGROUND', 'citation': 'Wong CA. The promise of pharmacogenetics in labor analgesia...tantalizing, but not there yet. Int J Obstet Anesth. 2012 Apr;21(2):105-8. doi: 10.1016/j.ijoa.2012.02.003. Epub 2012 Mar 9. No abstract available.'}, {'pmid': '23972758', 'type': 'BACKGROUND', 'citation': 'Landau R. Genetic contributions to labor pain and progress. Clin Perinatol. 2013 Sep;40(3):575-87. doi: 10.1016/j.clp.2013.05.014. Epub 2013 Jun 27.'}, {'pmid': '21710167', 'type': 'BACKGROUND', 'citation': 'Milman N. Postpartum anemia I: definition, prevalence, causes, and consequences. Ann Hematol. 2011 Nov;90(11):1247-53. doi: 10.1007/s00277-011-1279-z. Epub 2011 Jun 28.'}, {'pmid': '22533896', 'type': 'BACKGROUND', 'citation': 'Aubuchon-Endsley NL, Thomas DG, Kennedy TS, Grant SL, Valtr T. Interactive relations among maternal depressive symptomatology, nutrition, and parenting. Women Health. 2012;52(3):197-213. doi: 10.1080/03630242.2012.662933.'}]}, 'descriptionModule': {'briefSummary': 'In this pilot prospective longitudinal observational study, women who are pregnant and who will be experiencing childbirth for the first time will be recruited at the third trimester and observed longitudinally for psychiatric and pain characteristics until 3 months postpartum. The primary outcome is postpartum depression, assessed by Edinburgh Postnatal Depression Scale (EPDS). Infants will also be observed for infant development characteristics over time. Women who choose to receive labor epidural analgesia will be observed, as well as women who choose to avoid labor epidural analgesia. At baseline, women will complete baseline surveys as well as a baseline pain sensitivity test (quantitative sensory testing, QST). During labor, they will complete an electronic pain diary delivered by a bedside mobile device. Three postpartum assessments will occur over 3 months to assess maternal depression, other psychosocial variables, and infant development.', 'detailedDescription': "Our primary goal in this prospective observational study is to observe laboring women's sensitivity to, and characteristics of, labor pain, for the primary outcome of postpartum depression. Secondary endpoints include parenting self-efficacy, maternal-infant attachment, and infant development. The purpose of this pilot phase is to establish study protocol feasibility, and secondarily to determine trends that will inform future sample size calculations for a larger prospective study.\n\nOur key research questions are:\n\n1. What is the association between perceived intensity and unpleasantness of labor pain and postpartum behavioral health outcomes?\n2. Do personality, psychological, and genetic factors associated with depression correlate with differences in labor pain experience?\n\nOur hypothesis is that new mothers who have lower pain intensity and unpleasantness during the labor and delivery period will have a reduced risk for postpartum depression, defined by Edinburgh Postnatal Depression Score (EPDS) score. We secondarily hypothesize that women with lower labor pain intensity and unpleasantness scores will have improved maternal-infant attachment, higher parenting self-efficacy, lower perceived stress, and that their infants will exhibit improved child development.\n\nMethods: Baseline assessments of depression, anxiety, resiliency, perceived social support, pain catastrophising, and quantitative sensory testing (QST) will be undertaken. Baseline saliva samples will be collected for future genetic analysis. Throughout labor, pain will be assessed at high density and frequency by an electronic pain diary (mobile app developed by the study team), delivered at the bedside by a portable electronic device (Android tablet) provided by the study team. Labor variables will be recorded, including number of manual epidural supplemental doses, total dose of local anesthetic delivered, and the outcome of labor. Postpartum assessments will include depression, pain inventory, anxiety, perceived stress, maternal-infant bonding, breastfeeding, child development, and parenting self-efficacy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Healthy, nulliparous women, aged ≥18, planning spontaneous or induced labor and delivery at term gestation. Women who have risk factors for depression will be included. Risk factors are defined as history of abuse (partner, sexual, domestic, childhood, and substance); history of mental illness; lack of social support; and depression or anxiety. Women will have been and will continue to receive perinatal care at Magee-Womens Hospital or at The Midwife Center for Birth and Women's Health (TMC). A subset of women who receive care at TMC will choose to deliver at UPMC Mercy and will plan to avoid labor epidural analgesia. All women and their infants will be available for followup at 3 months.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Nulliparous\n* Aged ≥18\n* Proficiency in English language\n* Planning spontaneous or induced labor and delivery\n* Planning to avoid labor epidural analgesia (Midwife Center group)\n* Planning to utilize labor epidural analgesia (Magee-Womens Hospital group)\n* Receiving perinatal care at Magee-Womens Hospital or at The Midwife Center for Birth and Women's Health\n* Available and committed for followup at 3 months\n\nExclusion Criteria:\n\n* Severe maternal obstetric disease\n* Known or suspected severe fetal comorbid disease\n* Contraindications to neuraxial anesthesia\n* Unable to follow study protocol over 3 months\n* Plans for newborn adoption"}, 'identificationModule': {'nctId': 'NCT02692404', 'acronym': 'LPPD', 'briefTitle': 'Labor Pain and Postpartum Behavioral Health Outcomes Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Labor Pain and Postpartum Behavioral Health Outcomes Study', 'orgStudyIdInfo': {'id': 'PRO15030338'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hospital Birth', 'description': 'Healthy nulliparous participants, planning spontaneous vaginal or induced vaginal delivery, and planning delivery at a hospital woman-care birth center (Magee-Womens Hospital of UPMC) will be consented to participate in the study at their 3rd trimester clinic visit. Participants and their newborns will be followed for a period of 3 months postpartum. They will be planning to utilize labor epidural analgesia for pain control during labor.'}, {'label': 'Midwife Center Birth', 'description': 'Healthy nulliparous participants, planning vaginal delivery under the primary care of a nurse midwife (The Midwife Center for Birth and Womens Health, or UPMC-Mercy) will be consented to participate in the study at their 3rd trimester clinic visit. Participants and their newborns will be followed for a period of 3 months postpartum. They will be planning to avoid labor epidural analgesia for pain control during labor.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee Womens Hospital of UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15222', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Midwife Center for Birth and Womens Health', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Grace Lim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh School of Medicine; Magee-Womens Hospital of UPMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Grace Lim, MD, MS', 'investigatorAffiliation': 'University of Pittsburgh'}}}}