Status:
RECRUITING
Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women
Lead Sponsor:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Conditions:
Well-Being, Psychological
Eligibility:
FEMALE
18-55 years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- refusal to take part
- are unable to give or have withdrawn consent
- patients unable to communicate fluently in English
- patients who are less than 18 years old
- patients who had fetal demise or severely morbid fetal conditions such as intubation, cooling, expected surgical correction of congenital anomaly during hospitalization (although NICU admissions will be included)
- patients who were admitted in ICU
- patients who had failed neuraxial analgesia such as replaced epidurals or failed spinal requiring conversion to general anesthesia
- patients who had general anesthesia for cesarean delivery as defined by "GETA", including sedatives and deep sedation if not intubated
- patients who had intrapartum cesarean or had assisted/operative (i.e. vacuum, forceps) vaginal delivery.
Key Trial Info
Start Date :
July 9 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06002763
Start Date
July 9 2025
End Date
July 1 2026
Last Update
July 15 2025
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5