Recruiting

PROMIS-29

Sponsor:

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Code:

NCT06002763

Conditions

Well-Being, Psychological

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System)

WHOQoLBREF (World Health Organization Quality of Life Brief Version)

EQ-5D-3L1 (not an acronym)

Study Details

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.

Conditions

Well-Being, Psychological

Study ID

NCT06002763

Start date

Jul 9, 2025

Status verified date

Jul, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Vaginal delivery

Patients who have vaginal deliveries with neuraxial labour analgesia.

Cesarean delivery

Patients who have a scheduled cesarean delivery with neuraxial anesthesia.

Interventions

PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System)

PROMIS-29 is a survey designed to screen for pain, impairments in mood, physical function, and activities of daily living.

WHOQoLBREF (World Health Organization Quality of Life Brief Version)

The WHOQOL-BREF is a 26-item version of the 100-item WHOQOL-100 quality of life measure that addresses four quality of life domains: physical health, psychological health, social relationships and environment.

EQ-5D-3L1 (not an acronym)

The EQ-5D-3L1 is a generic measure of health status consisting of two parts. The first part assesses health in five dimensions: MOBILITY, SELFCARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY/DEPRESSION. The second part of the questionnaire consists of a VAS on which the patient rates their perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).

Primary outcome measure

  • PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score [ Time Frame: 24 hours ]
  • WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score [ Time Frame: 24 hours ]
  • EQ-5D-3L1 (not an acronym) survey score [ Time Frame: 24 hours ]
  • PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score [ Time Frame: 2 weeks ]
  • WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score [ Time Frame: 2 weeks ]
  • EQ-5D-3L1 (not an acronym) survey score [ Time Frame: 2 weeks ]
  • PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score [ Time Frame: 6 weeks ]
  • WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score [ Time Frame: 6 weeks ]
  • EQ-5D-3L1 (not an acronym) survey score [ Time Frame: 6 weeks ]
  • PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score [ Time Frame: 12 weeks ]
  • WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score [ Time Frame: 12 weeks ]
  • EQ-5D-3L1 (not an acronym) survey score [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Ronald George, MD

416-586-4800ron.george@uhn.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1X5

Contacts

Ronald George, MD

416-586-4800ron.george@uhn.ca

More Information

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Last update posted

Jul 15, 2025

Last verified

Jul, 2025

Keywords

  • cesarean delivery
  • vaginal delivery
  • postpartum recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Samuel Lunenfeld Research Institute, Mount Sinai Hospital on 2025-07-15.