Clinical trial NCT06002763: Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women
Official title: Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Well-Being, Psychological
Keywords: cesarean delivery
vaginal delivery
postpartum recovery
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who deliver vaginally or by scheduled cesarean section at 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.


Eligibility criteria: 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.

Primary outcomes:
measure: PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
timeFrame: 24 hours
measure: WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
timeFrame: 24 hours
measure: EQ-5D-3L1 (not an acronym) survey score
timeFrame: 24 hours
measure: PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
timeFrame: 2 weeks
measure: WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
timeFrame: 2 weeks
measure: EQ-5D-3L1 (not an acronym) survey score
timeFrame: 2 weeks
measure: PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
timeFrame: 6 weeks
measure: WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
timeFrame: 6 weeks
measure: EQ-5D-3L1 (not an acronym) survey score
timeFrame: 6 weeks
measure: PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score
timeFrame: 12 weeks
measure: WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score
timeFrame: 12 weeks
measure: EQ-5D-3L1 (not an acronym) survey score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Ronald George, MD
role: PRINCIPAL_INVESTIGATOR
References: