Actively Recruiting
OBS-QoR-10 in Patients With and Without Postpartum Hemorrhage
Led by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Updated on 2025-11-28
152
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Postpartum hemorrhage (PPH) remains a leading cause of maternal death and morbidity. Moreover, it also contributes to psychological trauma such as depression and post-traumatic stress disorder. The American College of Obstetrics and Gynecology (ACOG) and the Society for Maternal Fetal Medicine (SMFM) defines this morbidity as an unintended outcome in the birthing process that may have significant short-term and long-term consequences to an individual's health. A recent study in 2018 developed core outcomes set for PPH through Delphi consensus encompassing elements of prevention and management of PPH. Patient-reported outcomes, breastfeeding, and overall sense of wellbeing were not included in the final outcome set. Nevertheless, investigators felt strongly that they should be included, but further work was needed to assess the factors influencing the quality of recovery in the context of PPH. This is aligned with increasing recognition that patient experiences are important to improving the quality of care and quality of recovery after Cesarean delivery. The most effective, i.e. validated tool for assessing postpartum recovery is the Obstetric Quality of Recovery-10 (Obs-QoR-10). However its application in patients with PPH remains unexplored. It would appear logical that patient experiencing PPH experience a potentially more challenging recovery process which may include more surgical complications, depressive symptoms, sleep deprivation, physical exhaustion and stress due to unexpected and undesired delivery events. This study aims to compare Obs-QoR-10 scores in patients with and without PPH to evaluate the impact of severe postpartum bleeding on recovery outcomes using a matched case-control design. The investigators plan to determine the differences in Obs-QoR-10 scores between patients who experience PPH during childbirth and those deliver without PPH, and to evaluate the impact of PPH on specific recovery domains (physical comfort, emotional well-being, and functional recovery).
CONDITIONS
Official Title
OBS-QoR-10 in Patients With and Without Postpartum Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older who have delivered at Mount Sinai Hospital
- Delivery by vaginal or cesarean delivery with neuraxial analgesia or anesthesia
- Ability to communicate in English to complete the ObsQoR-10 survey
- For PPH group: Quantitative Blood Loss (QBL) of 1000 mL or more, or blood transfusion due to PPH, or transfer to ICU care due to PPH, or significant PPH intervention like hysterectomy or arterial embolization
- For non-PPH group: QBL less than 500 mL, no blood transfusion, and no need for higher level care such as HAU or ICU
You will not qualify if you...
- Patients with pre-existing psychiatric disorders affecting recovery assessment
- Patients with severe obstetric complications other than PPH, such as eclampsia or uterine rupture
- Overdistended uterus due to polyhydramnios (amniotic fluid index over 24 cm) or multiple gestation
- History of previous PPH with blood loss over 1000 mL, blood transfusion, or surgical treatments like Bakri balloon, B-Lynch sutures, uterine artery ligation, or embolization
- Body Mass Index (BMI) over 50
- Language barrier preventing English communication
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Actively Recruiting
Research Team
R
Ronald George, MD
CONTACT
K
Kristi Downey, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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