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

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

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.

Study Overview

• Status: Completed
• Conditions: Delivery Hemorrhage

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 397

Contacts and Locations

Study Locations

• France
  • VAR
    • Toulon, VAR, France, 83100
      • Centre Hospitalier Intercommunal de Toulon-La Seyne sur mer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of RGCs transfused during the first 24 hours postpartum		24 hours postpartum
Prescription of intra-venous iron during pregnancy	Number of patients with at least one prescription for IV iron during pregnancy.	24 hours postpartum
Hemoglobin level at hospital discharge	average hemoglobin level at discharge (before vs. after protocol implementation)	Day 7 postpartum
Treatments for the management of delivery haemorrhage.	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	Day 7 postpartum

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Investigators: Study Director: Géraldine SLEHOHER-LHERIAU, MD, Centre Intercommunal Toulon-La Seyne sur Mer

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Iron supplementation; Blood transfusion; Patient blood management; Delivery hemorrhage; Gestational anemia
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 2024-CHITS-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No