PROMIS-29 v2.1 for measuring physical and mental health after childbirth.
Official title: Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women
Run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · NCT06002763 · Data updated 2026-11-12
This project will test whether the PROMIS-29 survey accurately measures physical and mental health in women during the first 12 weeks after vaginal or cesarean birth.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 55 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | July 9, 2025 |
| Main results expected | July 2026 |
| Study ends | July 2026 |
| Registry record updated | July 15, 2025 |
| Trial ID | NCT06002763 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older with a singleton pregnancy delivered at or beyond 37 weeks by spontaneous vaginal delivery or scheduled cesarean with neuraxial analgesia who can read and consent in English are ideal candidates.
✕Probably not a fit
Patients unlikely to benefit include those under 18, non-English speakers, those with fetal demise or severe neonatal anomalies, ICU admission, or who received general anesthesia or had failed neuraxial analgesia during delivery.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a longitudinal, single-center observational cohort enrolling women after vaginal or scheduled cesarean delivery to complete virtual surveys at 0, 2, 6, and 12 weeks postpartum. Participants will complete the PROMIS-29 v2.1 along with WHOQoL-BREF and EQ-5D-3L to compare measures and examine concurrent validity. Analyses will focus on reliability (internal consistency and responsiveness over time) and the instrument's ability to capture changes in pain, mood, and function during early postpartum recovery. Findings will inform whether PROMIS-29 is suitable for routine use in obstetric follow-up.
Why it matters
Potential benefit: If successful, PROMIS-29 could give clinicians a standard, patient-centered way to track postpartum recovery and identify women who need extra support.
How similar studies have gone: PROMIS-29 has been validated in general and multiple clinical populations for measuring pain, mood, and function, but it has not been specifically validated in postpartum women.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Mount Sinai Hospital
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Ronald George, MD — Mount Sinai Hospital
- Study coordinator: Ronald George, MD
- Email: ron.george@uhn.ca
- Phone: 416-586-4800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.