Clinical trial NCT02692404: Labor Pain and Postpartum Behavioral Health Outcomes Study
Official title: Labor Pain and Postpartum Behavioral Health Outcomes Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 199
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Edinburgh Postnatal Depression Score (EPDS)
timeFrame: Postpartum Week 6
Secondary outcomes:
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
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Womens Hospital of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: The Midwife Center for Birth and Womens Health
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh School of Medicine; Magee-Womens Hospital of UPMC
name: Grace Lim, MD
role: PRINCIPAL_INVESTIGATOR
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