Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women

NCT06002763 | Recruiting

• 1 other identifier: 23-03
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

cesarean delivery; vaginal delivery; postpartum recovery

Outcome Measures

Primary Outcomes (12)

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

  The PROMIS survey score at 24 hours postpartum

  24 hours

• WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score

  The WHOQoLBREF survey score at 24 hours postpartum

  24 hours

• EQ-5D-3L1 (not an acronym) survey score

  The EQ-5D-3L1 survey score at 24 hours postpartum

  24 hours

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

  The PROMIS survey score at 2 weeks postpartum

  2 weeks

• WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score

  The WHOQoLBREF survey score at 2 weeks postpartum

  2 weeks

• EQ-5D-3L1 (not an acronym) survey score

  The EQ-5D-3L1 survey score at 2 weeks postpartum

  2 weeks

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

  The PROMIS survey scores at 6 weeks postpartum

  6 weeks

• WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score

  The WHOQoLBREF survey score at 6 weeks postpartum

  6 weeks

• EQ-5D-3L1 (not an acronym) survey score

  The EQ-5D-3L1 survey score at 6 weeks postpartum

  6 weeks

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

  The PROMIS survey score at 12 weeks postpartum

  12 weeks

• WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score

  The WHOQoLBREF survey score at 12 weeks postpartum

  12 weeks

• EQ-5D-3L1 (not an acronym) survey score

  The EQ-5D-3L1 survey score at 12 weeks postpartum

  12 weeks

Study Arms (2)

Vaginal delivery

Patients who have vaginal deliveries with neuraxial labour analgesia.

Other: PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System); Other: WHOQoLBREF (World Health Organization Quality of Life Brief Version); Other: EQ-5D-3L1 (not an acronym)

Cesarean delivery

Patients who have a scheduled cesarean delivery with neuraxial anesthesia.

Other: PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System); Other: WHOQoLBREF (World Health Organization Quality of Life Brief Version); Other: EQ-5D-3L1 (not an acronym)

Interventions

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

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

Also known as: Patient-Reported Outcomes Measurement Information System

Cesarean delivery; Vaginal delivery

WHOQoLBREF (World Health Organization Quality of Life Brief Version) OTHER

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.

Also known as: World Health Organization Quality of Life Brief Version

Cesarean delivery; Vaginal delivery

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

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).

Also known as: Global state of health numerical rating score 1-100

Cesarean delivery; Vaginal delivery

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who deliver vaginally or by scheduled cesarean section at Mount Sinai Hospital.

You may qualify if:

• years old and over
• singleton births
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Ronald George, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronald George, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 21, 2023
• Study Start: July 9, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)