Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women
NCT ID: NCT06002763
Last Updated: 2025-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
200 participants
OBSERVATIONAL
2025-07-09
2026-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Proactive, Personalized Postpartum Mental Healthcare
NCT03803189
Heart Health 4 New Moms: A Randomized Trial in the First Year After Preeclampsia
NCT03749746
Optimizing Health From Pregnancy Through One Year Postpartum
NCT03069690
EMA and mHealth in Preventing Postpartum Depression
NCT06777563
Telephone Coaching Intervention for Postpartum Depression and Anxiety
NCT04073043
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vaginal delivery
Patients who have vaginal deliveries with neuraxial labour analgesia.
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).
Cesarean delivery
Patients who have a scheduled cesarean delivery with neuraxial anesthesia.
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
55 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ronald George, MD
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mount Sinai Hospital
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
23-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.