Prospective Study on Feto-maternal outcoMe In aNemIc womEn

Active, not recruiting

• Conditions: Transfusion; Embolism, Thrombus; Bleeding; Transfusion-dependent Anemia; Anemia; Pregnancy Anemia; Pregnancy Bleeding; Placenta Diseases
• Interventions: Diagnostic Test: iron deficiency, coagulation abnormalities

• Registration Number: NCT05739097
• Lead Sponsor: Casa Sollievo della Sofferenza IRCCS

Brief Summary

Background Blood transfusions in pregnancy are usually urgent, unpredictable, and occur in otherwise healthy women. There is evidence of increasing rates of maternal red blood cell (RBC) transfusion around childbirth both in Europe and in US. Indeed, they are recorded in approximately 0.4-1.6% of all deliveries. Although obstetric patients use a small proportion of the blood supply overall (3-4%), however over the last years there has been a significant increase (about 30%) in the use of blood and blood products throughout pregnancy. Most available data relate to the peri-partum period, defined as those occurring from 48 hours before delivery onwards.

Anemia in pregnancy is associated with increased maternal mortality and fetal intrauterine growth restriction (IUGR). The risk of these adverse effects is proportional to the severity of anemia; for instance, preterm birth and low birth weight rates are particularly high among women with a hemoglobin below 7 g/dL.

The presence of anemia in at-term pregnant women is a rather frequent and unrecognized risk factor for peri-partum hemorrhage (PPH) transfusion. In a retrospective investigation, we have calculated that almost 20% of at-term pregnant women show iron deficiency anemia. It has been suggested that reduction of RBC transfusion in the context of PPH may decrease maternal mortality and, at the same time, reduce costs.

Patient's Blood Management (PBM) is a well-known strategy based on 1) identification of anemia; 2) reduction of blood loss and 3) reduction of RBC transfusion. In several medical specialties, recommendations based on available evidence highlighted the concept that a restrictive RBC administration is safe and efficacious. Despite the fact that the WHO has recommended PBM early 2010, the majority of hospitals are in need of guidelines to apply PBM in daily practice.

Rationale Anemia is a frequent and often unrecognized hallmark of at-term pregnancies. Systematic collection of data on transfusion practice during pregnancy and post-partum period are scarce.

The application of PBM in obstetrics is expected to improve pregnancy outcome and optimize resources.

Objectives Objectives of the present study are

1. To estimate: frequency of anemia in pregnancy and feto-maternal complications, distribution of haemorrhage aetiologies and transfusion indications.

2. To evaluate associations of these outcomes with gestational age, and transfusion dose.

Detailed Description

Design Prospective observational study. All consecutive pregnant women referred from January 1st 2022 to January 30th 2023 to PBM service at University of Foggia and IRCCS "Casa Sollievo della Sofferenza " , who will deliver at Ob/Gyn department in the same Institutions. Investigators will collect baseline clinical characteristics, blood count and all available laboratory parameters. Afterwards, investigators will collect feto-maternal outcomes, included data on possible transfusions.

Estimated Sample size : 2000 pregnant patients.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2023-01-27
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-20
• Last Update Submitted: 2023-02-20
• Study First Posted: 2023-02-22
• Last Update Posted: 2023-02-22
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bleeders	iron deficiency, coagulation abnormalities	Pregnant women at Ob/Gyn Dept
non-anemic women	iron deficiency, coagulation abnormalities	Pregnant women consecutively observed at Ob/Gyn Dept
anemic women	iron deficiency, coagulation abnormalities	Pregnant women at Ob/Gyn Dept

Primary Outcome Measures

Name	Time	Method
number of maternal deaths or venous thromboembolisms, hemorrhages	3 months	investigators will record maternal deaths; thrombosis; hemorrhage; anemia

Secondary Outcome Measures

Name	Time	Method
number of fetal deaths or intrauterine growth restriction	3 months	investigators will record number of fetal deaths and fetal growth restriction;

Trial Locations

Locations (2)

Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, Foggia, Italy

Gabriella Cicerone; 🇮🇹 Foggia, Italy