Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-01 @ 4:54 PM
Study NCT ID:
NCT06916832
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Implementing a Patient Blood Management Protocol on the Transfusion Rate in Delivery Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RGC transfusion rate', 'timeFrame': '24 hours postpartum', 'description': 'Comparison of the RGC transfusion rate over the length of stay following delivery hemorrhage between the 2 periods (before and after PBM implementation).'}], 'secondaryOutcomes': [{'measure': 'Number of RGCs transfused during the first 24 hours postpartum', 'timeFrame': '24 hours postpartum'}, {'measure': 'Prescription of intra-venous iron during pregnancy', 'timeFrame': '24 hours postpartum', 'description': 'Number of patients with at least one prescription for IV iron during pregnancy.'}, {'measure': 'Hemoglobin level at hospital discharge', 'timeFrame': 'Day 7 postpartum', 'description': 'average hemoglobin level at discharge (before vs. after protocol implementation)'}, {'measure': 'Treatments for the management of delivery haemorrhage.', 'timeFrame': 'Day 7 postpartum', 'description': 'Number of patients who will use the following treatments: Tranexamic acid, Fibrinogen, Syntocinon, Nalador, FFP transfusion, DA-RU (artificial delivery, uterine revision), surgical treatment, bakri balloon'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Delivery hemorrhage', 'Pregnancy', 'Blood transfusion', 'Patient blood management', 'Iron supplementation', 'Gestational anemia'], 'conditions': ['Delivery Hemorrhage']}, 'descriptionModule': {'briefSummary': 'According to the WHO, anemia is one of the ten most serious health problems in the world. During pregnancy, it affects 42% of women worldwide and 25% in France. It is associated with an increased risk of perinatal morbidity and mortality, and recourse to blood transfusion. The blood transfusion is itself also a source of thromboembolic morbidity and mortality, infectious diseases and pulmonary pathologies. In addition, the risk of hemorrhage, particularly during delivery, is inherent to all pregnancies and difficult to predict.\n\nSince 2010, the WHO has defined the rational use of blood products as the 4th global priority, and the need for countries to reduce blood transfusion. It introduces the concept of Patient Blood Management (PBM). This is a set of measures designed to manage anemia and bleeding in surgical patients, while avoiding the need for transfusion. These measures include preoperative screening for anemia and martial deficiency, iron and vitamin supplementation, intraoperative bleeding control and optimization of postoperative blood balance. Recommended by several national programs, PBM has developed rapidly in orthopedic and cardiac surgery, where numerous studies have demonstrated its effectiveness, particularly in terms of transfusion savings. In obstetrics, however, the implementation of PBM remains less widespread, notably due to the difficulty of getting teams on board, and the absence of protocolization.\n\nHowever, given the high prevalence of anemia in pregnant women, and the inherent risk of hemorrhage in all deliveries with potential recourse to blood transfusion, personalized optimization of PBM is a major challenge in obstetrics.\n\nThe PBM is currently being implemented in routine practice in the CHITS maternity department, in line with recommendations.\n\nIn this context, our research aims to assess the impact of this new approach. Our main hypothesis is that implementation of a PBM protocol would reduce the rate of transfusion in delivery hemorrhage.', 'detailedDescription': 'From 1 January 2023 to 31 December 2025, the investigators conducted a single-center, before-and-after study at the maternity unit of the Sainte Musse hospital in Toulon (level IIB maternity unit). This is a retrospective observational study with a retrospective section covering the period before the implementation of the PBM protocol between 1 January 2023 and 31 December 2024. Then a prospective part covering the period after the implementation of the PBM protocol, from 1 January 2025 to 31 December 2025.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women who suffered a delivery hemorrhage during childbirth,in the maternity ward of Hôpital Sainte Musse', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any patient who has had a delivery hemorrhage, whatever the mode of delivery\n\nExclusion Criteria:\n\n* Minor\n* Under legal protection\n* Hemoglobinopathies\n* Patient's refusal to participate in research"}, 'identificationModule': {'nctId': 'NCT06916832', 'acronym': 'PALOMA', 'briefTitle': 'Evaluation of the Impact of Implementing a Patient Blood Management Protocol on the Transfusion Rate in Delivery Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer'}, 'officialTitle': 'Evaluation of the Impact of Implementing a Patient Blood Management Protocol on the Transfusion Rate in Delivery Hemorrhage', 'orgStudyIdInfo': {'id': '2024-CHITS-018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Before protocol implementation', 'description': 'pregnant women who did not use the patient blood management protocol during their pregnancy. In other words, women who gave birth in 2023 and 2024.'}, {'label': 'After protocol implementation', 'description': 'pregnant women who benefited from the patient blood management protocol during their pregnancy. In other words, women who gave birth in 2025.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '83100', 'city': 'Toulon', 'state': 'VAR', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Géraldine SLEHOHER-LHERIAU, MD', 'role': 'CONTACT', 'email': 'geraldine.slehofer-lheriau@ch-toulon.fr', 'phone': '0494145913', 'phoneExt': '+33'}], 'facility': 'Centre Hospitalier Intercommunal de Toulon-La Seyne sur mer', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}], 'centralContacts': [{'name': 'Asmaa JOBIC', 'role': 'CONTACT', 'email': 'Asmaa.jobic@ch-toulon.fr', 'phone': '04 83 77 20 61', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Géraldine SLEHOHER-LHERIAU, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Intercommunal Toulon-La Seyne sur Mer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}