Using ObsQoR-10 to compare recovery after births with and without postpartum hemorrhage
Comparing the Obstetric Quality of Recovery-10 (OBS-QoR-10) in Patients With and Without Postpartum Hemorrhage: A Matched Case-control Study
This project uses the ObsQoR-10 survey to see if people who have postpartum hemorrhage after vaginal or cesarean birth report different recovery, breastfeeding, and wellbeing than those who do not.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 152 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07199803 on ClinicalTrials.gov |
What this trial studies
Researchers at Mount Sinai Hospital will enroll people aged 18 or older who delivered by vaginal or cesarean birth with neuraxial analgesia and can complete English surveys, and will separate them into PPH and non-PPH cohorts based on quantitative blood loss, transfusion, ICU transfer, or major interventions. Participants will complete the Obstetric Quality of Recovery-10 (ObsQoR-10) patient-reported outcome tool to measure recovery, breastfeeding status, and overall wellbeing after delivery. This observational comparison aims to identify factors linked to poorer recovery in the context of postpartum hemorrhage. Findings are intended to help incorporate patient-reported recovery measures into PPH outcome sets and guide postpartum support.
Who should consider this trial
Good fit: Adults (≥18) who delivered at Mount Sinai Hospital by vaginal or cesarean delivery with neuraxial analgesia, can communicate in English, and meet the study's PPH (e.g., QBL ≥1000 mL, transfusion, ICU transfer, or major intervention) or non-PPH (QBL <500 mL, no transfusion, no elevated care) criteria.
Not a fit: Patients with pre-existing psychiatric disorders affecting recovery assessment, those with severe non-PPH obstetric complications, non-English speakers, people with overdistended uteri or prior documented PPH, and those who delivered elsewhere are unlikely to receive direct benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify people at risk of poor recovery after PPH and improve postpartum support for wellbeing and breastfeeding.
How similar studies have performed: ObsQoR-10 has been used successfully to measure postpartum recovery after cesarean and vaginal births, but applying it specifically to compare outcomes in PPH versus non-PPH populations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Toronto, Ontario
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Ronald George, MD — Mount Sinai Hospital
- Study coordinator: Ronald George, MD
- Email: ron.george@uhn.ca
- Phone: 416-586-4800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.