NCT07199803 OBS-QoR-10 in Patients With and Without Postpartum Hemorrhage
| NCT ID | NCT07199803 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
| Condition | Postpartum Hemorrhage (Primary) |
| Study Type | OBSERVATIONAL |
| Enrollment | 152 participants |
| Start Date | 2025-10-03 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 152 participants in total. It began in 2025-10-03 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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).
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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)
Contact & Investigator
Ronald George, MD
PRINCIPAL INVESTIGATOR
MOUNT SINAI HOSPITAL
Frequently Asked Questions
Who can join the NCT07199803 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Postpartum Hemorrhage (Primary). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07199803 currently recruiting?
Yes, NCT07199803 is actively recruiting participants. Contact the research team at ron.george@uhn.ca for enrollment information.
Where is the NCT07199803 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07199803 clinical trial?
NCT07199803 is sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. The principal investigator is Ronald George, MD at MOUNT SINAI HOSPITAL. The trial plans to enroll 152 participants.