Actively Recruiting
Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 Survey for Physical and Mental Health in Postpartum Women
Led by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Updated on 2025-07-15
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the reliability and validity of the PROMIS-29 v2.1 survey for assessing physical and mental health in postpartum women. The PROMIS-29 survey screens for pain, mood impairments, physical function, and daily living activities. Although validated in general populations, it has not yet been studied specifically in women after childbirth. The study is observational and focuses on postpartum women following vaginal or cesarean delivery. Participants will complete virtual surveys at four time points: immediately after delivery (0 weeks), and then at 2, 6, and 12 weeks postpartum. The survey data from PROMIS-29 will be compared to established quality of life measures, including the WHOQoLBREF and EQ-5D-3L1 surveys. Two groups will be observed: women who had vaginal deliveries with neuraxial labor analgesia and those who underwent scheduled cesarean deliveries with neuraxial anesthesia. Throughout the study, participants will provide patient-reported outcomes via online surveys at the specified intervals. Researchers will evaluate the statistical validity and reliability of the PROMIS-29 tool by comparing it with other quality of life assessments. The primary outcomes include scores from PROMIS-29, WHOQoLBREF, and EQ-5D-3L1 surveys collected at each time point. The study will continue until July 2026, involving monitoring of physical and psychological well-being during the first 12 weeks after childbirth.
CONDITIONS
Brief 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 neuraxial anesthesia
- Provide informed written consent
You will not qualify if you...
- Refusal to participate
- Unable or withdrawn consent
- Unable to communicate fluently in English
- Under 18 years old
- Fetal demise or severely morbid fetal conditions requiring intensive interventions
- Admission to ICU
- Failed neuraxial analgesia requiring general anesthesia
- General anesthesia for cesarean delivery
- Intrapartum cesarean or assisted/operative vaginal delivery (vacuum, forceps)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) before delivery
Duration - 12 weeks
Participants complete a series of surveys assessing physical and mental health following delivery.
Survey assessments at 24 hours, 2 weeks, 6 weeks, and 12 weeks postpartum
Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Actively Recruiting
Research Team
R
Ronald George, MD
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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