Labor Pain and Postpartum Behavioral Health Outcomes Study

NCT02692404 | Completed

• 1 other identifier: PRO15030338
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Depression, Postpartum; Pregnancy; Child Development; Pain; Labor Pain

Keywords

Postpartum Depression; Perinatal Depression; Pregnancy; Anesthesia; Obstetric; Pain; Analgesia; Epidural; Midwife; Infant Development; Pain Management

Outcome Measures

Primary Outcomes (1)

• Edinburgh Postnatal Depression Score (EPDS)

  Postpartum Week 6

Secondary Outcomes (6)

• Perceived Stress

  Postpartum Day 1 or 2

• Brief Pain Inventory

  Postpartum Day 1 or 2, 6 weeks, and 3 months

• Maternal-Infant Attachment

  Postpartum Week 6, and 3 months

• Parenting Self-Efficacy

  Postpartum Week 6, and 3 months

• Child Development

  Postpartum Week 6, and 3 months

Study Arms (2)

Hospital Birth

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.

Midwife Center Birth

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Nulliparous
• Aged ≥18
• Proficiency in English language
• Planning spontaneous or induced labor and delivery
• Planning to avoid labor epidural analgesia (Midwife Center group)
• Planning to utilize labor epidural analgesia (Magee-Womens Hospital group)
• Receiving perinatal care at Magee-Womens Hospital or at The Midwife Center for Birth and Women's Health
• Available and committed for followup at 3 months

You may not qualify if:

• Severe maternal obstetric disease
• Known or suspected severe fetal comorbid disease
• Contraindications to neuraxial anesthesia
• Unable to follow study protocol over 3 months
• Plans for newborn adoption

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (2)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

The Midwife Center for Birth and Womens Health

Pittsburgh, Pennsylvania, 15222, United States

Location

Related Publications (33)

• 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: 12512766 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.

  PMID: 16730600 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.

  PMID: 18401329 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.

  PMID: 19318144 BACKGROUND

• Hirst KP, Moutier CY. Postpartum major depression. Am Fam Physician. 2010 Oct 15;82(8):926-33.

  PMID: 20949886 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.

  PMID: 23487258 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.

  PMID: 15883651 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.

  PMID: 22215285 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.

  PMID: 21515195 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.

  PMID: 24108418 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.

  PMID: 18357852 BACKGROUND

• 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: 23249931 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.

  PMID: 24797120 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.

  PMID: 14995921 BACKGROUND

• 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: 25046776 BACKGROUND

• 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: 25229827 BACKGROUND

• 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: 19336362 BACKGROUND

• 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: 20861420 BACKGROUND

• 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: 10739529 BACKGROUND

• 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: 11426893 BACKGROUND

• 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: 18166304 BACKGROUND

• 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: 24058502 BACKGROUND

• 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: 24552601 BACKGROUND

• 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: 22406985 BACKGROUND

• 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: 25766270 BACKGROUND

• 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: 3651732 BACKGROUND

• 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: 11972140 BACKGROUND

• 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: 20562010 BACKGROUND

• 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: 19141305 BACKGROUND

• 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: 22405670 BACKGROUND

• 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: 23972758 BACKGROUND

• 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: 21710167 BACKGROUND

• 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.

  PMID: 22533896 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples for DNA extraction

MeSH Terms

Conditions

Depression, Postpartum; Pain; Labor Pain; Agnosia

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Grace Lim, MD

  University of Pittsburgh School of Medicine; Magee-Womens Hospital of UPMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 26, 2016
• Study Start: January 1, 2016
• Primary Completion: August 8, 2017
• Study Completion: September 18, 2017
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (2)