Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:50 PM
Study NCT ID:
NCT07199803
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OBS-QoR-10 in Patients With and Without Postpartum Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 152}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2025-09-22', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Obstetric Quality of Recovery-10 (ObsQoR-10) score 24-48 hours', 'timeFrame': '24 hours', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Semi-quantitative blood loss total (ml)', 'timeFrame': '1 hour', 'description': 'Semi-quantitative blood loss total (ml) as measured postpartum'}, {'measure': 'Length of hospital stay (hours)', 'timeFrame': '4 days', 'description': 'Time from admission to discharge from hospital in hours'}, {'measure': 'Additional uterotonic medication administered - questionnaire', 'timeFrame': '24 hours', 'description': 'Presence of administration and dosing of any additional uterotonic medication.'}, {'measure': 'Blood transfusion', 'timeFrame': '48 hours', 'description': 'Administration of any blood product and amount given.'}, {'measure': 'Surgical interventions for PPH - questionnaire', 'timeFrame': '2 hours', 'description': 'Use of any surgical interventions for PPH as documented by the surgical team.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cesarean delivery', 'vaginal delivery', 'ObsQoR-10'], 'conditions': ['Postpartum Hemorrhage (Primary)']}, 'descriptionModule': {'briefSummary': "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.\n\nPatient-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.\n\nThe 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)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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:\n\n* Age (±5 years)\n* Parity (1 or \\>1)\n* Mode of delivery (vaginal vs. cesarean delivery)\n* Labour (Labouring and Non-labouring cesarean delivery)\n* Urgency (Scheduled vs Unscheduled Cesarean delivery)\n* Gestational age at delivery (± 2 weeks)\n* Delivery date within 2 weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older who have delivered at Mount Sinai Hospital.\n* Delivery via vaginal or cesarean delivery with neuraxial analgesia or anesthesia\n* Ability to communicate in English (to answer OBSQoR-10 survey) PPH Cohort\n\n * Quantitative Blood Loss (QBL) ≥ 1000 mL or,\n * Transfusion of blood due to PPH or,\n * Transfer to ICU level care due to PPH\n * Significant PPH intervention, i.e. hysterectomy or arterial embolization Non-PPH\n * QBL \\< 500 mL and,\n * No transfusion of blood products, and\n * No need for elevated care environment, i.e. HAU or ICU\n\nExclusion Criteria:\n\n* Patients with pre-existing psychiatric disorders affecting recovery assessment.\n* Patients who experience severe obstetric complications other than PPH (e.g., eclampsia, uterine rupture).\n* Overdistended uterus due to; Polyhydramnios (amniotic fluid index \\>24 cm) or multiple gestation\n* 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)\n* BMI \\> 50\n* Language barrier (English)'}, 'identificationModule': {'nctId': 'NCT07199803', 'briefTitle': 'OBS-QoR-10 in Patients With and Without Postpartum Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital'}, 'officialTitle': 'Comparing the Obstetric Quality of Recovery-10 (OBS-QoR-10) in Patients With and Without Postpartum Hemorrhage: A Matched Case-control Study', 'orgStudyIdInfo': {'id': '25-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vaginal delivery with PPH', 'description': 'Patients who deliver vaginally with a quantitative blood loss greater than or equal to 1000ml.', 'interventionNames': ['Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool']}, {'label': 'Vaginal delivery without PPH', 'description': 'Patients who deliver vaginally with a quantitative blood loss less than 1000ml.', 'interventionNames': ['Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool']}, {'label': 'Cesarean delivery with PPH', 'description': 'Patients who deliver vaginally with a quantitative blood loss greater than or equal to 1000ml.', 'interventionNames': ['Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool']}, {'label': 'Cesarean delivery without PPH', 'description': 'Patients who deliver vaginally with a quantitative blood loss less than 1000ml.', 'interventionNames': ['Other: Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool']}], 'interventions': [{'name': 'Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Cesarean delivery with PPH', 'Cesarean delivery without PPH', 'Vaginal delivery with PPH', 'Vaginal delivery without PPH']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G1X5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Ronald George, MD', 'role': 'CONTACT', 'email': 'ron.george@uhn.ca', 'phone': '416-586-4800', 'phoneExt': '2681'}, {'name': 'Kristi Downey, MSc', 'role': 'CONTACT', 'email': 'kristi.downey@uhn.ca', 'phone': '416-586-4800', 'phoneExt': '2366'}, {'name': 'Jeroen De Haes, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Naveed Siddiqui, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mrinalini Balki, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Philip Ye, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Ronald George, MD', 'role': 'CONTACT', 'email': 'ron.george@uhn.ca', 'phone': '416-586-4800', 'phoneExt': '2681'}, {'name': 'Kristi Downey, MSc', 'role': 'CONTACT', 'email': 'kristi.downey@uhn.ca', 'phone': '416-586-4800', 'phoneExt': '2366'}], 'overallOfficials': [{'name': 'Ronald George, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MOUNT SINAI HOSPITAL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}