Labor Pain and Postpartum Behavioral Health Outcomes Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Edinburgh Postnatal Depression Score (EPDS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous
- •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
排除标准
- •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
结局指标
主要结局
Edinburgh Postnatal Depression Score (EPDS)
时间窗: Postpartum Week 6
次要结局
- 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)
研究者
Grace Lim, MD, MS
Associate Professor
University of Pittsburgh