Labor Pain and Postpartum Behavioral Health Outcomes Study (LPPD)
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|ClinicalTrials.gov Identifier: NCT02692404|
Recruitment Status : Completed
First Posted : February 26, 2016
Last Update Posted : January 18, 2020
|Condition or disease|
|Depression, Postpartum Pregnancy Child Development Pain Labor Pain|
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.
|Study Type :||Observational|
|Actual Enrollment :||199 participants|
|Official Title:||Labor Pain and Postpartum Behavioral Health Outcomes Study|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||August 8, 2017|
|Actual Study Completion Date :||September 18, 2017|
Healthy nulliparous participants, planning spontaneous vaginal or induced vaginal delivery, and planning delivery at a hospital woman-care birth center (Magee-Womens Hospital of UPMC) will be consented to participate in the study at their 3rd trimester clinic visit. Participants and their newborns will be followed for a period of 3 months postpartum. They will be planning to utilize labor epidural analgesia for pain control during labor.
Midwife Center Birth
Healthy nulliparous participants, planning vaginal delivery under the primary care of a nurse midwife (The Midwife Center for Birth and Womens Health, or UPMC-Mercy) will be consented to participate in the study at their 3rd trimester clinic visit. Participants and their newborns will be followed for a period of 3 months postpartum. They will be planning to avoid labor epidural analgesia for pain control during labor.
- Edinburgh Postnatal Depression Score (EPDS) [ Time Frame: Postpartum Week 6 ]
- Perceived Stress [ Time Frame: Postpartum Day 1 or 2 ]
- Brief Pain Inventory [ Time Frame: Postpartum Day 1 or 2, 6 weeks, and 3 months ]
- Maternal-Infant Attachment [ Time Frame: Postpartum Week 6, and 3 months ]
- Parenting Self-Efficacy [ Time Frame: Postpartum Week 6, and 3 months ]
- Child Development [ Time Frame: Postpartum Week 6, and 3 months ]
- Edinburgh Postnatal Depression Score (EPDS) [ Time Frame: 3 months ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692404
|United States, Pennsylvania|
|Magee Womens Hospital of UPMC|
|Pittsburgh, Pennsylvania, United States, 15213|
|The Midwife Center for Birth and Womens Health|
|Pittsburgh, Pennsylvania, United States, 15222|
|Principal Investigator:||Grace Lim, MD||University of Pittsburgh School of Medicine; Magee-Womens Hospital of UPMC|