Delivery HemorrhagePALOMANCT06916832
Evaluation of a Patient Blood Management Protocol Impact on the Transfusion Rate in Delivery Hemorrhage
An observational study of Delivery Hemorrhage, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Delivery Hemorrhage
- How many people
- 397 participants
- Where
- 1 siteFrance
- Study dates
- 23 Dec 2024to 31 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women who suffered a delivery hemorrhage during childbirth,in the maternity ward of Hôpital Sainte Musse
Who may be able to join
- Any patient who has had a delivery hemorrhage, whatever the mode of delivery
Who cannot join
- Minor
- Under legal protection
- Hemoglobinopathies
- Patient's refusal to participate in research
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Intercommunal de Toulon-La Seyne sur mer
Toulon, VAR, 83100
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Delivery Hemorrhage
- Keywords
- Delivery hemorrhage, Pregnancy, Blood transfusion, Patient blood management, Iron supplementation, Gestational anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours postpartum
Secondary outcomes (4)
Number of RGCs transfused during the first 24 hours postpartum
Measured: 24 hours postpartum
Prescription of intra-venous iron during pregnancy
Number of patients with at least one prescription for IV iron during pregnancy.
Measured: 24 hours postpartum
Hemoglobin level at hospital discharge
average hemoglobin level at discharge (before vs. after protocol implementation)
Measured: 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
Measured: Day 7 postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start23 Dec 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery HemorrhageStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Géraldine SLEHOHER-LHERIAU, MD, Study director, Centre Intercommunal Toulon-La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916832
- Sponsor's protocol ID
- 2024-CHITS-018
- Acronym
- PALOMA
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2025
- Last updated
- 16 Jun 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Implementing a Patient Blood Management Protocol on the Transfusion Rate in Delivery Hemorrhage
- ClinicalTrials.gov ID
- NCT06916832
- Acronym / sponsor ID
- PALOMA / 2024-CHITS-018
- Conditions
- Delivery Hemorrhage
- Keywords
- Delivery hemorrhage, Pregnancy, Blood transfusion, Patient blood management, Iron supplementation, Gestational anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 8 Apr 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women who suffered a delivery hemorrhage during childbirth,in the maternity ward of Hôpital Sainte Musse
Key inclusion criteria (1 listed)
- Any patient who has had a delivery hemorrhage, whatever the mode of delivery
Key exclusion criteria (4 listed)
- Minor
- Under legal protection
- Hemoglobinopathies
- Patient's refusal to participate in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RGC transfusion rate
Time frame: 24 hours postpartum
Comparison of the RGC transfusion rate over the length of stay following delivery hemorrhage between the 2 periods (before and after PBM implementation).
4 secondary outcomes
Number of RGCs transfused during the first 24 hours postpartum
Time frame: 24 hours postpartum
Prescription of intra-venous iron during pregnancy
Time frame: 24 hours postpartum
Hemoglobin level at hospital discharge
Time frame: Day 7 postpartum
Treatments for the management of delivery haemorrhage.
Time frame: Day 7 postpartum
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 16 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Géraldine SLEHOHER-LHERIAU, MD study director
Centre Intercommunal Toulon-La Seyne sur Mer
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 Delivery Hemorrhage, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
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 1 inclusion and 4 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 16 Jun 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 France. 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?
RGC transfusion rate (time frame: 24 hours postpartum). 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 16 Jun 2026.