PROMIS-29 v2.1 for measuring physical and mental health after childbirth.
Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06002763 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.