Well-Being, PsychologicalNCT06002763
Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women
An observational study of Well-Being, Psychological, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Psychological
- What is being tested?
- PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System), WHOQoLBREF (World Health Organization Quality of Life Brief Version) and EQ-5D-3L1 (not an acronym)
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jul 2025to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients who deliver vaginally or by scheduled cesarean section at Mount Sinai Hospital.
Who may be able to join
- 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
Who cannot join
- 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- are unable to give or have withdrawn consent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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G1X5
Ronald George, MD, 416-586-4800 ext. 2681, ron.george@uhn.ca
Denise Medeiros, MD
About this study
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
- Being tested
- 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)
- Keywords
- cesarean delivery, vaginal delivery, postpartum recovery
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System)Other
Also called 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)Other
Also called 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)Other
Also called Global state of health numerical rating score 1-100
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).
| Study group | Role | What they receive |
|---|---|---|
| Vaginal delivery | Patients who have vaginal deliveries with neuraxial labour analgesia. Receives: 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
The PROMIS survey score at 24 hours postpartum
Measured: 24 hours
WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
The WHOQoLBREF survey score at 24 hours postpartum
Measured: 24 hours
EQ-5D-3L1 (not an acronym) survey score
The EQ-5D-3L1 survey score at 24 hours postpartum
Measured: 24 hours
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
The PROMIS survey score at 2 weeks postpartum
Measured: 2 weeks
WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
The WHOQoLBREF survey score at 2 weeks postpartum
Measured: 2 weeks
EQ-5D-3L1 (not an acronym) survey score
The EQ-5D-3L1 survey score at 2 weeks postpartum
Measured: 2 weeks
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
The PROMIS survey scores at 6 weeks postpartum
Measured: 6 weeks
WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
The WHOQoLBREF survey score at 6 weeks postpartum
Measured: 6 weeks
EQ-5D-3L1 (not an acronym) survey score
The EQ-5D-3L1 survey score at 6 weeks postpartum
Measured: 6 weeks
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
The PROMIS survey score at 12 weeks postpartum
Measured: 12 weeks
WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
The WHOQoLBREF survey score at 12 weeks postpartum
Measured: 12 weeks
EQ-5D-3L1 (not an acronym) survey score
The EQ-5D-3L1 survey score at 12 weeks postpartum
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start9 Jul 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald George, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002763
- Sponsor's protocol ID
- 23-03
- Status last verified
- Jul 2025
- First submitted
- 16 Aug 2023
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women
- ClinicalTrials.gov ID
- NCT06002763
- Acronym / sponsor ID
- 23-03
- Conditions
- Well-Being, Psychological
- Keywords
- cesarean delivery, vaginal delivery, postpartum recovery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal delivery | – | 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)Patients who have vaginal deliveries with neuraxial labour analgesia. |
| Cesarean delivery | – | 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)Patients who have a scheduled cesarean delivery with neuraxial anesthesia. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who deliver vaginally or by scheduled cesarean section at Mount Sinai Hospital.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System)Also: Patient-Reported Outcomes Measurement Information SystemPROMIS-29 is a survey designed to screen for pain, impairments in mood, physical function, and activities of daily living. | Other | Cesarean delivery, Vaginal delivery |
| WHOQoLBREF (World Health Organization Quality of Life Brief Version)Also: World Health Organization Quality of Life Brief VersionThe 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. | Other | Cesarean delivery, Vaginal delivery |
| EQ-5D-3L1 (not an acronym)Also: Global state of health numerical rating score 1-100The 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 | Cesarean delivery, Vaginal delivery |
Primary outcome
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
Time frame: 24 hours
The PROMIS survey score at 24 hours postpartum
WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
Time frame: 24 hours
The WHOQoLBREF survey score at 24 hours postpartum
EQ-5D-3L1 (not an acronym) survey score
Time frame: 24 hours
The EQ-5D-3L1 survey score at 24 hours postpartum
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
Time frame: 2 weeks
The PROMIS survey score at 2 weeks postpartum
WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
Time frame: 2 weeks
The WHOQoLBREF survey score at 2 weeks postpartum
EQ-5D-3L1 (not an acronym) survey score
Time frame: 2 weeks
The EQ-5D-3L1 survey score at 2 weeks postpartum
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
Time frame: 6 weeks
The PROMIS survey scores at 6 weeks postpartum
WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
Time frame: 6 weeks
The WHOQoLBREF survey score at 6 weeks postpartum
EQ-5D-3L1 (not an acronym) survey score
Time frame: 6 weeks
The EQ-5D-3L1 survey score at 6 weeks postpartum
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
Time frame: 12 weeks
The PROMIS survey score at 12 weeks postpartum
WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
Time frame: 12 weeks
The WHOQoLBREF survey score at 12 weeks postpartum
EQ-5D-3L1 (not an acronym) survey score
Time frame: 12 weeks
The EQ-5D-3L1 survey score at 12 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronald George, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Well-Being, Psychological, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ronald George, MD (416-586-4800 ext. 2681, ron.george@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score (time frame: 24 hours). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.