OBS-QoR-10 in Patients With and Without Postpartum Hemorrhage
NCT ID: NCT07199803
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
152 participants
OBSERVATIONAL
2025-09-30
2026-07-31
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Vaginal delivery with PPH
Patients who deliver vaginally with a quantitative blood loss greater than or equal to 1000ml.
Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
The ObsQoR-10 tool aims to quantitatively measure functional recovery at 24 hours postpartum. It includes 10 questions on a 0 to 10 scale, aimed at pain management, the adverse effects of narcotics and the perception of recovery by the patient.
Vaginal delivery without PPH
Patients who deliver vaginally with a quantitative blood loss less than 1000ml.
Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
The ObsQoR-10 tool aims to quantitatively measure functional recovery at 24 hours postpartum. It includes 10 questions on a 0 to 10 scale, aimed at pain management, the adverse effects of narcotics and the perception of recovery by the patient.
Cesarean delivery with PPH
Patients who deliver vaginally with a quantitative blood loss greater than or equal to 1000ml.
Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
The ObsQoR-10 tool aims to quantitatively measure functional recovery at 24 hours postpartum. It includes 10 questions on a 0 to 10 scale, aimed at pain management, the adverse effects of narcotics and the perception of recovery by the patient.
Cesarean delivery without PPH
Patients who deliver vaginally with a quantitative blood loss less than 1000ml.
Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
The ObsQoR-10 tool aims to quantitatively measure functional recovery at 24 hours postpartum. It includes 10 questions on a 0 to 10 scale, aimed at pain management, the adverse effects of narcotics and the perception of recovery by the patient.
Interventions
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Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
The ObsQoR-10 tool aims to quantitatively measure functional recovery at 24 hours postpartum. It includes 10 questions on a 0 to 10 scale, aimed at pain management, the adverse effects of narcotics and the perception of recovery by the patient.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
FEMALE
Yes
Sponsors
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Samuel Lunenfeld Research Institute, Mount Sinai Hospital
OTHER
Responsible Party
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Principal Investigators
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Ronald George, MD
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Locations
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Mount Sinai Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Ronald George, MD
Role: primary
Kristi Downey, MSc
Role: backup
Other Identifiers
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25-03
Identifier Type: -
Identifier Source: org_study_id