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 range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Postpartum Hemorrhage (Primary) trials