Prospective Study on Feto-maternal outcoMe In aNemIc womEn (MINNIE)

Prospective Study on Feto-maternal outcoMe In aNemIc womEn : MINNIE Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anemia; Bleeding; Placenta Diseases; Pregnancy Anemia; Transfusion-dependent Anemia; Pregnancy Bleeding; Transfusion; Embolism, Thrombus
• Intervention / Treatment: Diagnostic test: iron deficiency, coagulation abnormalities

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 Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• Italy
  • Foggia, Italy, 71121
    • Gabriella Cicerone
  • Foggia
    • San Giovanni Rotondo, Foggia, Italy, 71013
      • Casa Sollievo della Sofferenza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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 " .

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non-anemic women; Pregnant women consecutively observed at Ob/Gyn Dept	Diagnostic test: iron deficiency, coagulation abnormalities; avoid transfusions, where possible
anemic women; Pregnant women at Ob/Gyn Dept	Diagnostic test: iron deficiency, coagulation abnormalities; avoid transfusions, where possible
bleeders; Pregnant women at Ob/Gyn Dept	Diagnostic test: iron deficiency, coagulation abnormalities; avoid transfusions, where possible

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of maternal deaths or venous thromboembolisms, hemorrhages	investigators will record maternal deaths; thrombosis; hemorrhage; anemia	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of fetal deaths or intrauterine growth restriction	investigators will record number of fetal deaths and fetal growth restriction;	3 months

Collaborators and Investigators

• Sponsor: Casa Sollievo della Sofferenza IRCCS
• Collaborators: University of Bari; University of Foggia
• Investigators: Principal Investigator: Elvira Grandone, MD, CSS

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): February 28, 2025

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Estimate): February 22, 2023

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Embolism and Thrombosis; Pregnancy Complications; Embolism; Hemorrhage; Anemia; Placenta Diseases
• Other Study ID Numbers: MINNIE, version 12/06/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No