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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 15, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Dec 2025 to Jul 2026
    • Start date changed from estimate of May 2025 to Jul 9, 2025
    • Site details revised
    v8
  2. Notable Start date: Mar 2025 to May 2025v7
  3. Notable Primary and study completion dates: Feb 2025 to Dec 2025
    • Start date: Oct 2024 to Mar 2025
    • Site contact updated
    v6
  4. Notable Start date: May 2024 to Oct 2024
    • Primary and study completion dates: Dec 2024 to Feb 2025
    v5
  5. Minor Start date: Apr 2024 to May 2024v4
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  1. Minor Start date: Mar 2024 to Apr 2024
    • Site contact updated
    v3
  2. Notable Primary and study completion dates: Apr 2024 to Dec 2024
    • Start date: Sep 2023 to Mar 2024
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06002763
Lead Sponsor Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Conditions
(from sponsor)
Well-Being, Psychological
Related terms Psychological Well-Being
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov