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

StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Primary endpoint(s) modified Show 6 more changesShow less
    • Trial completed
    • Final enrollment: 136 participants (planned 152)
    • Primary completion date changed from estimate of Jul 2026 to Mar 10, 2026
    • Study completion date changed from estimate of Jul 2026 to Mar 13, 2026
    • Eligibility criteria expanded, about 16 words
    • Site details revised
  2. Start date changed from estimate of Sep 2025 to Oct 3, 2025v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07199803
Lead Sponsor Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Conditions
(from sponsor)		 Postpartum Hemorrhage (Primary)
Related terms Postpartum Hemorrhage
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov