Labor Pain and Postpartum Behavioral Health Outcomes Study

Pain Clinical Trial

— LPPD  

Official title:

Labor Pain and Postpartum Behavioral Health Outcomes Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692404
• Other study ID #: PRO15030338
• Status: Completed
• Start date: January 2016
• Est. completion date: September 18, 2017

Study information

• Verified date: January 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Our key research questions are:

1. What is the association between perceived intensity and unpleasantness of labor pain and postpartum behavioral health outcomes?

2. Do personality, psychological, and genetic factors associated with depression correlate with differences in labor pain experience?

Our 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.

Methods: 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: September 18, 2017
• Est. primary completion date: August 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Magee Womens Hospital of UPMC	Pittsburgh	Pennsylvania
United States	The Midwife Center for Birth and Womens Health	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (33)

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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. — View Citation

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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. Review. — View 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. — View 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. — View 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. — View 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):219-21. doi: 10.1213/ANE.0000000000000322. — View Citation

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edinburgh Postnatal Depression Score (EPDS)		Postpartum Week 6
Secondary	Perceived Stress		Postpartum Day 1 or 2
Secondary	Brief Pain Inventory		Postpartum Day 1 or 2, 6 weeks, and 3 months
Secondary	Maternal-Infant Attachment		Postpartum Week 6, and 3 months
Secondary	Parenting Self-Efficacy		Postpartum Week 6, and 3 months
Secondary	Child Development		Postpartum Week 6, and 3 months
Secondary	Edinburgh Postnatal Depression Score (EPDS)		3 months