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

Not yet recruiting

• Conditions: Well-Being, Psychological
• Interventions: 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)

• Registration Number: NCT06002763
• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25
• Study Start: 2025-05
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaginal delivery	WHOQoLBREF (World Health Organization Quality of Life Brief Version)	Patients who have vaginal deliveries with neuraxial labour analgesia.
Cesarean delivery	WHOQoLBREF (World Health Organization Quality of Life Brief Version)	Patients who have a scheduled cesarean delivery with neuraxial anesthesia.
Vaginal delivery	PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System)	Patients who have vaginal deliveries with neuraxial labour analgesia.
Cesarean delivery	PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System)	Patients who have a scheduled cesarean delivery with neuraxial anesthesia.
Cesarean delivery	EQ-5D-3L1 (not an acronym)	Patients who have a scheduled cesarean delivery with neuraxial anesthesia.
Vaginal delivery	EQ-5D-3L1 (not an acronym)	Patients who have vaginal deliveries with neuraxial labour analgesia.

Primary Outcome Measures

Name	Time	Method
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score	12 weeks	The PROMIS survey score at 12 weeks postpartum
WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score	12 weeks	The WHOQoLBREF survey score at 12 weeks postpartum
EQ-5D-3L1 (not an acronym) survey score	12 weeks	The EQ-5D-3L1 survey score at 12 weeks postpartum

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada