Evaluation of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.1 for Postpartum Women
- Conditions
- Well-Being, Psychological
- Registration Number
- NCT06002763
- Lead Sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - 18 years old and over<br><br> - singleton births<br><br> - 37 or more weeks gestational age<br><br> - multiparous or nulliparous patients<br><br> - spontaneous vaginal delivery or scheduled cesarean delivery with labor analgesia or<br> neuraxial anesthesia<br><br> - give informed written consent<br><br>Exclusion Criteria:<br><br> - refusal to take part<br><br> - are unable to give or have withdrawn consent<br><br> - patients unable to communicate fluently in English<br><br> - patients who are less than 18 years old<br><br> - patients who had fetal demise or severely morbid fetal conditions such as<br> intubation, cooling, expected surgical correction of congenital anomaly during<br> hospitalization (although NICU admissions will be included)<br><br> - patients who were admitted in ICU<br><br> - patients who had failed neuraxial analgesia such as replaced epidurals or failed<br> spinal requiring conversion to general anesthesia<br><br> - patients who had general anesthesia for cesarean delivery as defined by GETA,<br> including sedatives and deep sedation if not intubated<br><br> - patients who had intrapartum cesarean or had assisted/operative (i.e. vacuum,<br> forceps) vaginal delivery.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score;WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score;EQ-5D-3L1 (not an acronym) survey score;PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score;WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score;EQ-5D-3L1 (not an acronym) survey score;PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score;WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score;EQ-5D-3L1 (not an acronym) survey score;PROMIS-29 v2.1 (Patient-Reported Outcomes Measurement Information System) survey score;WHOQoLBREF (World Health Organization Quality of Life Brief Version) survey score;EQ-5D-3L1 (not an acronym) survey score
- Secondary Outcome Measures
Name Time Method