Prospective Study on Feto-maternal outcoMe In aNemIc womEn

NCT05739097 | Unknown

• 1 other identifier: MINNIE, version 12/06/2021
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 2

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. 1.To estimate: frequency of anemia in pregnancy and feto-maternal complications, distribution of haemorrhage aetiologies and transfusion indications.
2. 2.To evaluate associations of these outcomes with gestational age, and transfusion dose.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• number of maternal deaths or venous thromboembolisms, hemorrhages

  investigators will record maternal deaths; thrombosis; hemorrhage; anemia

  3 months

Secondary Outcomes (1)

• number of fetal deaths or intrauterine growth restriction

  3 months

Study Arms (3)

non-anemic women

Pregnant women consecutively observed at Ob/Gyn Dept

Diagnostic Test: iron deficiency, coagulation abnormalities

anemic women

Pregnant women at Ob/Gyn Dept

Diagnostic Test: iron deficiency, coagulation abnormalities

bleeders

Pregnant women at Ob/Gyn Dept

Diagnostic Test: iron deficiency, coagulation abnormalities

Interventions

iron deficiency, coagulation abnormalities DIAGNOSTIC_TEST

avoid transfusions, where possible

anemic women; bleeders; non-anemic women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Investigators will enroll consecutive pregnant women hospitalized for delivery from January 1st 2022 to January 30th 2023 to Ob/Gyn dept. at University of Foggia and IRCCS "Casa Sollievo della Sofferenza " .

You may qualify if:

• 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

You may not qualify if:

• Not signed informed consent

Sponsors & Collaborators

• Casa Sollievo della Sofferenza IRCCS: lead
• University of Foggia: collaborator
• University of Bari: collaborator

Study Sites (2)

Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Gabriella Cicerone

Foggia, 71121, Italy

Location

MeSH Terms

Conditions

Anemia; Embolism; Thrombosis; Hemorrhage; Placenta Diseases

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Elvira Grandone, MD

  CSS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 22, 2023
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

IT (2)