Actively Recruiting
Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women
Led by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Updated on 2025-07-15
200
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
There is no widely used, statistically validated assessment for physical and mental health for the short- to medium-term in a postpartum population. PROMIS-29 has been validated for the assessment of these factors in a generic population, but has not been specifically evaluated for use with postpartum women. This study is a longitudinal, single center observational cohort study designed to evaluate the reliability of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 survey in a postpartum population. PROMIS-29 is a survey designed to screen for pain, impairments in mood, physical function, and activities of daily living. While this survey has shown utility in other populations, it has yet to be assessed in an obstetric population. The investigators plan to recruit patients who are recently postpartum from vaginal or cesarean delivery to complete virtual surveys at defined time points (0, 2, 6, and 12 weeks after delivery). The investigators will subject survey data to statistical measures of validity and reliability comparing with contemporaneously collected surveys of established metrics for quality of life (WHOQoLBREF) and general (global) state of health (numerical rating score 1-100). The hypothesis is that the PROMIS-29 v2.1 questionnaire is a statistically valid and reliable means of assessing physical and mental health in a postpartum population.
CONDITIONS
Official Title
Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old and over
- singleton births
- 37 or more weeks gestational age
- multiparous or nulliparous patients
- spontaneous vaginal delivery or scheduled cesarean delivery with labor analgesia or neuraxial anesthesia
- give informed written consent
You will not qualify if you...
- refusal to take part
- unable to give or withdrawn consent
- unable to communicate fluently in English
- younger than 18 years old
- fetal demise or severely morbid fetal conditions such as intubation, cooling, or expected surgical correction of congenital anomaly during hospitalization (NICU admissions included)
- admitted to ICU
- failed neuraxial analgesia requiring epidural replacement or conversion to general anesthesia
- had general anesthesia for cesarean delivery including sedatives and deep sedation if not intubated
- intrapartum cesarean or assisted/operative vaginal delivery (vacuum, forceps)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Actively Recruiting
Research Team
R
Ronald George, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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