Status:
RECRUITING
OBS-QoR-10 in Patients With and Without Postpartum Hemorrhage
Lead Sponsor:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Conditions:
Postpartum Hemorrhage (Primary)
Eligibility:
FEMALE
18+ years
Brief Summary
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 Am...
Eligibility Criteria
Inclusion
- Patients aged 18 years or older who have delivered at Mount Sinai Hospital.
- Delivery via vaginal or cesarean delivery with neuraxial analgesia or anesthesia
- Ability to communicate in English (to answer OBSQoR-10 survey) PPH Cohort
- Quantitative Blood Loss (QBL) ≥ 1000 mL or,
- Transfusion of blood due to PPH or,
- Transfer to ICU level care due to PPH
- Significant PPH intervention, i.e. hysterectomy or arterial embolization Non-PPH
- QBL \< 500 mL and,
- No transfusion of blood products, and
- No need for elevated care environment, i.e. HAU or ICU
Exclusion
- Patients with pre-existing psychiatric disorders affecting recovery assessment.
- Patients who experience severe obstetric complications other than PPH (e.g., eclampsia, uterine rupture).
- Overdistended uterus due to; Polyhydramnios (amniotic fluid index \>24 cm) or multiple gestation
- History of previous PPH (documented with blood loss of \>1000 ml, blood transfusion, use surgical methods such as Bakri balloon, B-Lynch sutures, uterine artery ligation or embolization)
- BMI \> 50
- Language barrier (English)
Key Trial Info
Start Date :
October 3 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT07199803
Start Date
October 3 2025
End Date
July 1 2026
Last Update
November 28 2025
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5