Skip to content

Prospective Study on Feto-maternal outcoMe In aNemIc womEn

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05739097
Acronym
MINNIE
Enrollment
2000
Registered
2023-02-22
Start date
2022-01-01
Completion date
2025-02-28
Last updated
2023-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTiron deficiency, coagulation abnormalities

avoid transfusions, where possible

Sponsors

University of Foggia
CollaboratorOTHER
University of Bari
CollaboratorOTHER
Casa Sollievo della Sofferenza IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
number of maternal deaths or venous thromboembolisms, hemorrhages3 monthsinvestigators will record maternal deaths; thrombosis; hemorrhage; anemia

Secondary

MeasureTime frameDescription
number of fetal deaths or intrauterine growth restriction3 monthsinvestigators will record number of fetal deaths and fetal growth restriction;

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026