Evaluation of a Patient Blood Management Protocol Impact on the Transfusion Rate in Delivery Hemorrhage

NCT06916832 | Completed

• 1 other identifier: 2024-CHITS-018
• Study Type: observational
• Target: 397
• Locations: 1 country
• Sites: 1

Brief Summary

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. Since 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. However, 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. The PBM is currently being implemented in routine practice in the CHITS maternity department, in line with recommendations. In 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.

Conditions

Delivery Hemorrhage

Keywords

Delivery hemorrhage; Pregnancy; Blood transfusion; Patient blood management; Iron supplementation; Gestational anemia

Outcome Measures

Primary Outcomes (1)

• RGC transfusion rate

  Comparison of the RGC transfusion rate over the length of stay following delivery hemorrhage between the 2 periods (before and after PBM implementation).

  24 hours postpartum

Secondary Outcomes (4)

• Number of RGCs transfused during the first 24 hours postpartum

  24 hours postpartum

• Prescription of intra-venous iron during pregnancy

  24 hours postpartum

• Hemoglobin level at hospital discharge

  Day 7 postpartum

• Treatments for the management of delivery haemorrhage.

  Day 7 postpartum

Study Arms (2)

Before protocol implementation

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.

After protocol implementation

pregnant women who benefited from the patient blood management protocol during their pregnancy. In other words, women who gave birth in 2025.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women who suffered a delivery hemorrhage during childbirth,in the maternity ward of Hôpital Sainte Musse

You may qualify if:

• Any patient who has had a delivery hemorrhage, whatever the mode of delivery

You may not qualify if:

• Minor
• Under legal protection
• Hemoglobinopathies
• Patient's refusal to participate in research

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

Centre Hospitalier Intercommunal de Toulon-La Seyne sur mer

Toulon, VAR, 83100, France

Location

Study Officials

• Géraldine SLEHOHER-LHERIAU, MD

  Centre Intercommunal Toulon-La Seyne sur Mer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 8, 2025
• Study Start: December 23, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)