Patient Blood Management in Obstetrics

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorCorniche Hospital

About this trial

Obstetric anemia and hemorrhage are major causes of maternal morbidity and increased healthcare utilization. Although red blood cell (RBC) transfusion is commonly used, it is associated with higher rates of postpartum complications, including pneumonia, renal failure, and cardiac events (Kloka et al.).

Patient Blood Management (PBM) is an evidence-based approach that aims to optimize a patient's own blood and reduce avoidable transfusion through three pillars: treating anemia and iron deficiency, minimizing blood loss, and avoiding unnecessary transfusion. International guidelines support PBM in obstetrics, but data on comprehensive program implementation remain limited due to barriers such as resource constraints and the need for multidisciplinary coordination.

Aims , objectives and Hypotheses Primary Aim To assess the association between PBM implementation and blood product utilisation among all obstetric deliveries at Corniche Hospital between 2018 and 2025.

Primary Objective To estimate the change over time in the mean number of blood product units transfused per delivery (combined and by product type).

Primary Hypothesis Increasing PBM maturity over time, particularly following comprehensive PBM implementation in 2022, is associated with a significant reduction in mean blood product units transfused per delivery, after adjusting for changes in case-mix.

Secondary Objectives Secondary objectives include evaluating changes in transfusion-related practice and anemia outcomes, including proportion of deliveries receiving any transfusion; pretransfusion hemoglobin thresholds in non-actively bleeding patients (where definable); predelivery anemia prevalence (and iron therapy utilization where captured).

Maternal outcomes will be evaluated by reporting composite morbidity; postpartum hysterectomy; hospital length of stay; High Dependency unit (HDU)/ICU admission and length of stay; 28-day all-cause emergency readmissions; in-hospital mortality. Neonatal outcomes will not be included.

At Corniche Hospital, prior evaluation in cases of major obstetric hemorrhage showed that PBM reduced blood product use and improved hemoglobin recovery without increasing morbidity (Ansari et al.). This study extends the assessment to all deliveries from 2018-2025 to evaluate hospital-wide changes in transfusion practice and maternal outcomes as PBM implementation matured.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All women delivered at Corniche Hospital during the study period

Disqualifiers

None

Trial population

All women who delivered at corniche during the study period regardless of the type of delivery: vaginal, operative vaginal, cesarean section (including livebirth or stillbirth)

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

44,000 Participants
are grouped into 1 trial group
Group A: All patients delivered between 2018 and 2025

Trial outcomes

Primary outcomes

1

Mean number of blood product units transfused per delivery

measured combined units of RBC, FFP and platelet units measured per delivery

Time frame
2018 - 2025

Secondary outcomes

1

Proportion of deliveries receiving any blood product (RBC/FFP/platelets)

proportion of delivery who recieved blood transfusion

Time frame
2018-2025
2

Mean pretransfusion Hb in non-actively bleeding patients (where definable)

Hemoglobin level that triggered blood transfusion

Time frame
2018-2025
3

Predelivery anemia prevalence (define threshold consistent with local policy; e.g., Hb <11g/dL)

prevalence of anemia at the time of delivery

Time frame
2018-2025
4

Utilization of IV iron pre- and post-delivery (if available and reliable)

percentage of women reciving IV iron in the antenatal and postnatal period

Time frame
2018-2025

Other outcomes

Sponsors and contacts

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