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

Launched by SAMUEL LUNENFELD RESEARCH INSTITUTE, MOUNT SINAI HOSPITAL · Aug 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a survey called PROMIS-29 v2.1, which is designed to assess the physical and mental health of women after giving birth. Right now, there isn't a widely accepted way to measure how new mothers are feeling, both physically and emotionally, in the weeks following delivery. The researchers want to see if this survey can effectively evaluate the well-being of postpartum women, whether they had a vaginal birth or a cesarean section. To do this, they will be inviting women who have recently given birth to complete the survey at different times—0, 2, 6, and 12 weeks after delivery—and compare these results with other established health measures.

Women who are eligible to participate must be at least 18 years old, have had a single baby born at 37 weeks or later, and should be able to give informed consent. Those who had a complicated birth or certain medical conditions may not be able to join. If you take part in this study, you will fill out the survey online, helping researchers understand how effective this tool is for new mothers. Your input could be valuable in improving how healthcare providers support women during this important time.

Gender

FEMALE

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• • are unable to give or have withdrawn consent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.