Labor Pain and Postpartum Behavioral Health Outcomes Study

Completed

Conditions studied: Depression, Postpartum, Pregnancy, Child Development, Pain, Labor Pain

In brief

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.

Key facts

Study ID

NCT02692404

Run by

University of Pittsburgh

People needed

199

Starts

2016-01-01

Expected to finish

2017-09-18

Last updated by the study team

2020-01-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Magee Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• The Midwife Center for Birth and Womens Health — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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