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

NCT ID: NCT07199803

Last Updated: 2025-09-30

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Postpartum Hemorrhage (Primary)

Keywords

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cesarean delivery vaginal delivery ObsQoR-10

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type 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.

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

Intervention Type 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.

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

Intervention Type 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.

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

Intervention Type 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.

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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Ronald George, MD

Role: CONTACT

Phone: 416-586-4800

Email: [email protected]

Kristi Downey, MSc

Role: CONTACT

Phone: 416-586-4800

Email: [email protected]

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