RecruitingNot Applicable

OBS-QoR-10 in Patients With and Without Postpartum Hemorrhage

Canada152 participantsStarted 2025-10-03

Plain-language 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).

Who can participate

Age range18 Years

SexFEMALE

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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)

What they're measuring

Obstetric Quality of Recovery-10 (ObsQoR-10) score 24-48 hours

Timeframe: 24 hours

Trial details

NCT IDNCT07199803

SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07

Contact for this trial

Ronald George, MD

416-586-4800 ron.george@uhn.ca