Patient Blood Management in Obstetrics

NCT07544017 | Not Yet Recruiting

• 1 other identifier: REC/2026/ CH10022604
• Study Type: observational
• Target: 44,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patient Blood Management; Blood Product Transfusion for All Conditions

Keywords

Blood product transfusion; Obstetrics; Patient blood management

Outcome Measures

Primary Outcomes (1)

• Mean number of blood product units transfused per delivery

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

  2018 - 2025

Secondary Outcomes (10)

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

  2018-2025

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

  2018-2025

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

  2018-2025

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

  2018-2025

• Composite morbidity

  2018-2025

Study Arms (1)

All patients delivered between 2018 and 2025

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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)

You may qualify if:

• All women delivered at Corniche Hospital during the study period

You may not qualify if:

• None

Sponsors & Collaborators

• Corniche Hospital: lead

Study Sites (1)

Corniche Hospital

Abu Dhabi, United Arab Emirates

Location

Related Publications (5)

• Kloka JA, Friedrichson B, Jasny T, Old O, Piekarski F, Zacharowski K, Neef V. Anemia, red blood cell transfusion and administration of blood products in obstetrics: a nationwide analysis of more than 6 million cases from 2011-2020. Blood Transfus. 2024 Jan;22(1):37-45. doi: 10.2450/BloodTransfus.528. Epub 2023 Sep 15.

  PMID: 37847205 BACKGROUND

• Ansari T, Wani S, Hofmann A, Shetty N, Sangani K, Stamp CJ, Murray K, Trentino KM. Outcomes Associated with a Patient Blood Management Program in Major Obstetric Hemorrhage: A Retrospective Cohort Study. Anesth Analg. 2026 Jan 1;142(1):114-123. doi: 10.1213/ANE.0000000000007292. Epub 2024 Nov 21.

  PMID: 39570778 BACKGROUND

• Munoz M, Stensballe J, Ducloy-Bouthors AS, Bonnet MP, De Robertis E, Fornet I, Goffinet F, Hofer S, Holzgreve W, Manrique S, Nizard J, Christory F, Samama CM, Hardy JF. Patient blood management in obstetrics: prevention and treatment of postpartum haemorrhage. A NATA consensus statement. Blood Transfus. 2019 Mar;17(2):112-136. doi: 10.2450/2019.0245-18. Epub 2019 Feb 6.

  PMID: 30865585 BACKGROUND

• Shaylor R, Weiniger CF, Austin N, Tzabazis A, Shander A, Goodnough LT, Butwick AJ. National and International Guidelines for Patient Blood Management in Obstetrics: A Qualitative Review. Anesth Analg. 2017 Jan;124(1):216-232. doi: 10.1213/ANE.0000000000001473.

  PMID: 27557476 BACKGROUND

• Surbek D, Vial Y, Girard T, Breymann C, Bencaiova GA, Baud D, Hornung R, Taleghani BM, Hosli I. Patient blood management (PBM) in pregnancy and childbirth: literature review and expert opinion. Arch Gynecol Obstet. 2020 Feb;301(2):627-641. doi: 10.1007/s00404-019-05374-8. Epub 2019 Nov 14.

  PMID: 31728665 BACKGROUND

Study Officials

• Tarek Ansari, FFARCSI

  Corniche Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarek Ansari, FFARCSI

CONTACT

+971561173994; tansari@seha.ae

Saleema Wani, FRCOG

CONTACT

+971506227139; saleemaw@seha.ae

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesia department

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)