NCT06002763 Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women
| NCT ID | NCT06002763 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
| Condition | Well-Being, Psychological |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-07-09 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-07-09 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Ronald George, MD
PRINCIPAL INVESTIGATOR
MOUNT SINAI HOSPITAL
Frequently Asked Questions
Who can join the NCT06002763 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 55 Years, studying Well-Being, Psychological. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06002763 currently recruiting?
Yes, NCT06002763 is actively recruiting participants. Contact the research team at ron.george@uhn.ca for enrollment information.
Where is the NCT06002763 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06002763 clinical trial?
NCT06002763 is sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. The principal investigator is Ronald George, MD at MOUNT SINAI HOSPITAL. The trial plans to enroll 200 participants.