Labor Pain and Postpartum Behavioral Health Outcomes Study
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Depression, Women's Studies |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/24/2018 |
| Start Date: | January 2016 |
| End Date: | July 2019 |
| Contact: | Lia M Farrell, B.S. |
| Email: | farrelll2@upmc.edu |
| Phone: | 412-641-2179 |
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.
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.
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.
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.
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
We found this trial at
2
sites
300 Halket St.
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Phone: 412-641-2179
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
Click here to add this to my saved trials
Click here to add this to my saved trials