Labor Pain and Postpartum Behavioral Health Outcomes Study

Completed

• Conditions: Pain; Pregnancy; Depression, Postpartum; Labor Pain; Child Development

• Registration Number: NCT02692404
• Lead Sponsor: University of Pittsburgh

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.

Detailed 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-26
• Primary Completion: 2017-08-08
• Study Completion: 2017-09-18
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 199

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Edinburgh Postnatal Depression Score (EPDS)	Postpartum Week 6

Secondary Outcome Measures

Name	Time	Method
Child Development	Postpartum Week 6, and 3 months
Brief Pain Inventory	Postpartum Day 1 or 2, 6 weeks, and 3 months
Maternal-Infant Attachment	Postpartum Week 6, and 3 months
Edinburgh Postnatal Depression Score (EPDS)	3 months
Perceived Stress	Postpartum Day 1 or 2
Parenting Self-Efficacy	Postpartum Week 6, and 3 months

Trial Locations

Locations (2)

Magee Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

The Midwife Center for Birth and Womens Health; 🇺🇸 Pittsburgh, Pennsylvania, United States