An observational study in Anemia, Pregnancy Anemia and Pregnancy Bleeding, sponsored by Casa Sollievo della Sofferenza IRCCS. Status unknown at 2 sites in Italy. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-02-22.
Sponsored by Casa Sollievo della Sofferenza IRCCS · Observational
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
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.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's enrollment of 2,000 is above the median of 270 across 368 observational studies indexed under Anemia.
Browse Anemia studies →Casa Sollievo della Sofferenza IRCCS is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 " .
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant women consecutively observed at Ob/Gyn Dept
Diagnostic Test: iron deficiency, coagulation abnormalities
Pregnant women at Ob/Gyn Dept
Diagnostic Test: iron deficiency, coagulation abnormalities
Pregnant women at Ob/Gyn Dept
Diagnostic Test: iron deficiency, coagulation abnormalities
avoid transfusions, where possible
number of maternal deaths or venous thromboembolisms, hemorrhages
investigators will record maternal deaths; thrombosis; hemorrhage; anemia
Time frame: 3 months
number of fetal deaths or intrauterine growth restriction
investigators will record number of fetal deaths and fetal growth restriction;
Time frame: 3 months
Plan to share: Undecided
Started Jan 2022 (actual). Primary completion is estimated for Dec 2024, 35 months after the start.
Of 124 non-industry observational studies under Anemia, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 84. This study's planned 35 months is above that.
Counting every sponsor, half of 145 studies reached it within 30 months; a quarter within 12 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Casa Sollievo della Sofferenza IRCCS