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NCT Number: NCT07199803

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

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location status: Recruiting

Location contact

Jeroen De Haes, MD

SUB_INVESTIGATOR

Kristi Downey, MSc

CONTACT

[email protected]

416-586-4800 ext. 2366

Mrinalini Balki, MD

SUB_INVESTIGATOR

Naveed Siddiqui, MD

SUB_INVESTIGATOR

Philip Ye, MD

SUB_INVESTIGATOR

Ronald George, MD

CONTACT

[email protected]

416-586-4800 ext. 2681

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool

Other

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.

Primary outcomes

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

    Time frame: 24 hours

    ObsQoR-10 score between 24 and 48 hours postpartum. There are 10 questions, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing.

Secondary outcomes

  1. Semi-quantitative blood loss total (ml)

    Time frame: 1 hour

    Semi-quantitative blood loss total (ml) as measured postpartum

  2. Length of hospital stay (hours)

    Time frame: 4 days

    Time from admission to discharge from hospital in hours

  3. Additional uterotonic medication administered - questionnaire

    Time frame: 24 hours

    Presence of administration and dosing of any additional uterotonic medication.

  4. Blood transfusion

    Time frame: 48 hours

    Administration of any blood product and amount given.

  5. Surgical interventions for PPH - questionnaire

    Time frame: 2 hours

    Use of any surgical interventions for PPH as documented by the surgical team.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristi Downey, MSc

CONTACT

[email protected]

416-586-4800 ext. 2366

Ronald George, MD

CONTACT

[email protected]

416-586-4800 ext. 2681

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

Comparing the Obstetric Quality of Recovery-10 (OBS-QoR-10) in Patients With and Without Postpartum Hemorrhage: A Matched Case-control Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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