Postpartum Hemorrhage (Primary)NCT07199803
OBS-QoR-10 in Patients With and Without Postpartum Hemorrhage
An observational study of Postpartum Hemorrhage (Primary), run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage (Primary)
- What is being tested?
- Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
- How many people
- 136 participants
- Where
- 1 siteCanada
- Study dates
- 3 Oct 2025to 13 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients that deliver at Mount Sinai Hospital with measured blood loss greater than or equal to 1000ml, and a set of controls matching the following criteria with measured blood loss less than 1000ml: * Age (±5 years) * Parity (1 or >1) * Mode of delivery (vaginal vs. cesarean delivery) * Labour (Labouring and Non-labouring cesarean delivery) * Urgency (Scheduled vs Unscheduled Cesarean delivery) * Gestational age at delivery (± 4 weeks) * Delivery date within 2 weeks
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Obstetric Quality of Recovery-10 (OBS-QoR-10) in Patients With and Without Postpartum Hemorrhage: A Matched Case-control Study
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).
- Conditions
- Postpartum Hemorrhage (Primary)
- Being tested
- Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
- Keywords
- cesarean delivery, vaginal delivery, ObsQoR-10
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring ToolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal delivery with PPH | Patients who deliver vaginally with a quantitative blood loss greater than or equal to 1000ml. Receives: Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool | |
| Vaginal delivery without PPH | Patients who deliver vaginally with a quantitative blood loss less than 1000ml. Receives: Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool | |
| Cesarean delivery with PPH | Patients who deliver vaginally with a quantitative blood loss greater than or equal to 1000ml. Receives: Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool | |
| Cesarean delivery without PPH | Patients who deliver vaginally with a quantitative blood loss less than 1000ml. Receives: Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24-72 hours
ObsQoR-10 score between 24 and 72 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.
Measured: 72 hours
Secondary outcomes (5)
Semi-quantitative blood loss total (ml)
Semi-quantitative blood loss total (ml) as measured postpartum
Measured: 1 hour
Length of hospital stay (hours)
Time from admission to discharge from hospital in hours
Measured: 4 days
Additional uterotonic medication administered - questionnaire
Presence of administration and dosing of any additional uterotonic medication.
Measured: 24 hours
Blood transfusion
Administration of any blood product and amount given.
Measured: 48 hours
Surgical interventions for PPH - questionnaire
Use of any surgical interventions for PPH as documented by the surgical team.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start3 Oct 2025
- Primary completion10 Mar 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Hemorrhage (Primary)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald George, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199803
- Sponsor's protocol ID
- 25-03
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Obstetric Quality of Recovery-10 (OBS-QoR-10) in Patients With and Without Postpartum Hemorrhage: A Matched Case-control Study
- ClinicalTrials.gov ID
- NCT07199803
- Acronym / sponsor ID
- 25-03
- Conditions
- Postpartum Hemorrhage (Primary)
- Keywords
- cesarean delivery, vaginal delivery, ObsQoR-10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vaginal delivery with PPH | – | Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring ToolPatients who deliver vaginally with a quantitative blood loss greater than or equal to 1000ml. |
| Vaginal delivery without PPH | – | Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring ToolPatients who deliver vaginally with a quantitative blood loss less than 1000ml. |
| Cesarean delivery with PPH | – | Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring ToolPatients who deliver vaginally with a quantitative blood loss greater than or equal to 1000ml. |
| Cesarean delivery without PPH | – | Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring ToolPatients who deliver vaginally with a quantitative blood loss less than 1000ml. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that deliver at Mount Sinai Hospital with measured blood loss greater than or equal to 1000ml, and a set of controls matching the following criteria with measured blood loss less than 1000ml: * Age (±5 years) * Parity (1 or >1) * Mode of delivery (vaginal vs. cesarean delivery) * Labour (Labouring and Non-labouring cesarean delivery) * Urgency (Scheduled vs Unscheduled Cesarean delivery) * Gestational age at delivery (± 4 weeks) * Delivery date within 2 weeks
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring ToolThe 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. | Other | Cesarean delivery with PPH, Cesarean delivery without PPH, Vaginal delivery with PPH, Vaginal delivery without PPH |
Primary outcome
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24-72 hours
Time frame: 72 hours
ObsQoR-10 score between 24 and 72 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.
5 secondary outcomes
Semi-quantitative blood loss total (ml)
Time frame: 1 hour
Length of hospital stay (hours)
Time frame: 4 days
Additional uterotonic medication administered - questionnaire
Time frame: 24 hours
Blood transfusion
Time frame: 48 hours
Surgical interventions for PPH - questionnaire
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Postpartum Hemorrhage (Primary)
Active, not recruitingObservational study
Intact Cord Placental Delivery vs Delayed Cord Clamping
Intact Cord Placental Delivery, Delayed Cord Clamping
Recruiting
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Postpartum Hemorrhage (Primary)
RecruitingPhase 3
EVE TRIAL , ALMA SYSTAM
Postpartum Haemorrhage (PPH), PPH
Not yet recruiting
Prophylactic Regimen of Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative for Primary Prevention of Postpartum Hemorrhage in Intrapartum Cesarean Section Versus Intravenous Carbetocin Alone
Post Partum Hemorrhage
Recruiting
Effect of Extracellular Calcium on Carbetocin Mediated Contractility in Human Myometrium
Postpartum Hemorrhage (Primary)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald George, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage (Primary), run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstetric Quality of Recovery-10 (ObsQoR-10) score 24-72 hours (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.