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NCT Number: NCT02692404

Labor Pain and Postpartum Behavioral Health Outcomes Study

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Magee Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States

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About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Edinburgh Postnatal Depression Score (EPDS)

    Time frame: Postpartum Week 6

Secondary outcomes

  1. Perceived Stress

    Time frame: Postpartum Day 1 or 2

  2. Brief Pain Inventory

    Time frame: Postpartum Day 1 or 2, 6 weeks, and 3 months

  3. Maternal-Infant Attachment

    Time frame: Postpartum Week 6, and 3 months

  4. Parenting Self-Efficacy

    Time frame: Postpartum Week 6, and 3 months

  5. Child Development

    Time frame: Postpartum Week 6, and 3 months

  6. Edinburgh Postnatal Depression Score (EPDS)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Acronym: LPPD

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 26, 2016
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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