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Status unknownNCT05739097MINNIEUpdated Feb 22, 2023

Prospective Study on Feto-maternal outcoMe In aNemIc womEn

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

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.
Read the 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.

02

Conditions studied

  • Anemia
  • Pregnancy Anemia
  • Pregnancy Bleeding
  • Transfusion-dependent Anemia
  • Transfusion; Embolism, Thrombus
  • Bleeding
  • Placenta Diseases
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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 " .

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

Exclusion criteria:

  1. Not signed informed consent
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testiron deficiency, coagulation abnormalities

    avoid transfusions, where possible

05

What researchers measure

Primary outcomes

  1. number of maternal deaths or venous thromboembolisms, hemorrhages

    investigators will record maternal deaths; thrombosis; hemorrhage; anemia

    Time frame: 3 months

Secondary outcomes

  1. number of fetal deaths or intrauterine growth restriction

    investigators will record number of fetal deaths and fetal growth restriction;

    Time frame: 3 months

06

Study locations

2 sites
  • Casa Sollievo della Sofferenza
    San Giovanni Rotondo, Foggia 71013, Italy
  • Gabriella Cicerone
    Foggia, 71121, Italy
07

References and documents

Study documents

  • Study protocol · Jun 12, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT05739097
Lead sponsor
Casa Sollievo della Sofferenza IRCCS
Collaborators
University of Foggia, University of Bari
Responsible party
Sponsor
First posted
Feb 22, 2023
Start date
Jan 1, 2022
Primary completion
Dec 31, 2024 (estimated)
Completion
Feb 28, 2025 (estimated)
Last update
Feb 22, 2023

Study contacts

Elvira Grandone, MD
principal investigator · CSS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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