Prospective Study on Feto-maternal outcoMe In aNemIc womEn

NCT ID: NCT05739097

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2025-02-28

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.

Conditions

Anemia; Pregnancy Anemia; Pregnancy Bleeding; Transfusion-dependent Anemia; Transfusion; Embolism, Thrombus; Bleeding; Placenta Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

non-anemic women

Pregnant women consecutively observed at Ob/Gyn Dept

iron deficiency, coagulation abnormalities

Intervention Type: DIAGNOSTIC_TEST

avoid transfusions, where possible

anemic women

Pregnant women at Ob/Gyn Dept

iron deficiency, coagulation abnormalities

Intervention Type: DIAGNOSTIC_TEST

avoid transfusions, where possible

bleeders

Pregnant women at Ob/Gyn Dept

iron deficiency, coagulation abnormalities

Intervention Type: DIAGNOSTIC_TEST

avoid transfusions, where possible

Interventions

iron deficiency, coagulation abnormalities

avoid transfusions, where possible

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. all consecutive pregnant women who will sign the informed consent referred to Ob/Gyn dept. at University of Foggia, University of Bari and IRCCS "Casa Sollievo della Sofferenza " to deliver from January 1st 2022 to January 30th 2023

Exclusion Criteria

2. Not signed informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Foggia

OTHER

Sponsor Role: collaborator

University of Bari

OTHER

Sponsor Role: collaborator

Casa Sollievo della Sofferenza IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elvira Grandone, MD

Role: PRINCIPAL_INVESTIGATOR

CSS

Locations

Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

Gabriella Cicerone

Foggia, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

MINNIE, version 12/06/2021

Identifier Type: -

Identifier Source: org_study_id