AnemiaMINNIENCT05739097
Prospective Study on Feto-maternal outcoMe In aNemIc womEn
An observational study of Anemia and Pregnancy Anemia, run by Casa Sollievo della Sofferenza IRCCS at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anemia, Pregnancy Anemia, Pregnancy Bleeding
- What is being tested?
- iron deficiency, coagulation abnormalities
- How many people
- 2,000 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2022to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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 " .
Who may be able to join
- 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
Who cannot join
- Not signed informed consent
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Gabriella Cicerone
Foggia, 71121
Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013
About this study
Official title: 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.
Read more
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
- To estimate: frequency of anemia in pregnancy and feto-maternal complications, distribution of haemorrhage aetiologies and transfusion indications.
- 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.
- Conditions
- Anemia, Pregnancy Anemia, Pregnancy Bleeding, Transfusion-dependent Anemia, Transfusion; Embolism, Thrombus, Bleeding
- Being tested
- iron deficiency, coagulation abnormalities
- Medical subject headings
- Anemia, Embolism, Thrombosis, Hemorrhage, Placenta Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron deficiency, coagulation abnormalitiesDiagnostic test
avoid transfusions, where possible
| Study group | Role | What they receive |
|---|---|---|
| non-anemic women | Pregnant women consecutively observed at Ob/Gyn Dept Receives: Diagnostic Test: iron deficiency, coagulation abnormalities | |
| anemic women | Pregnant women at Ob/Gyn Dept Receives: Diagnostic Test: iron deficiency, coagulation abnormalities | |
| bleeders | Pregnant women at Ob/Gyn Dept Receives: Diagnostic Test: iron deficiency, coagulation abnormalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of maternal deaths or venous thromboembolisms, hemorrhages
investigators will record maternal deaths; thrombosis; hemorrhage; anemia
Measured: 3 months
Secondary outcomes (1)
number of fetal deaths or intrauterine growth restriction
investigators will record number of fetal deaths and fetal growth restriction;
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Casa Sollievo della Sofferenza IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Foggia, University of Bari
- Responsible party
- Sponsor
- Investigators
- Elvira Grandone, MD, Principal investigator, CSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739097
- Sponsor's protocol ID
- MINNIE, version 12/06/2021
- Acronym
- MINNIE
- Status last verified
- Feb 2023
- First submitted
- 27 Jan 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Feto-maternal outcoMe In aNemIc womEn : MINNIE Study
- ClinicalTrials.gov ID
- NCT05739097
- Acronym / sponsor ID
- MINNIE / MINNIE, version 12/06/2021
- Conditions
- Anemia, Pregnancy Anemia, Pregnancy Bleeding, Transfusion-dependent Anemia, Transfusion; Embolism, Thrombus, Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Casa Sollievo della Sofferenza IRCCSUniversity, hospital or other
- Collaborators
- University of Foggia, University of Bari
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To estimate: frequency of anemia in pregnancy and feto-maternal complications, distribution of haemorrhage aetiologies and transfusion indications.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-anemic women | – | Diagnostic Test: iron deficiency, coagulation abnormalitiesPregnant women consecutively observed at Ob/Gyn Dept |
| anemic women | – | Diagnostic Test: iron deficiency, coagulation abnormalitiesPregnant women at Ob/Gyn Dept |
| bleeders | – | Diagnostic Test: iron deficiency, coagulation abnormalitiesPregnant women at Ob/Gyn Dept |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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 " .
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Not signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iron deficiency, coagulation abnormalitiesavoid transfusions, where possible | Diagnostic test | anemic women, bleeders, non-anemic women |
Primary outcome
number of maternal deaths or venous thromboembolisms, hemorrhages
Time frame: 3 months
investigators will record maternal deaths; thrombosis; hemorrhage; anemia
1 secondary outcome
number of fetal deaths or intrauterine growth restriction
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elvira Grandone, MD principal investigator
CSS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Pregnancy Anemia, run by Casa Sollievo della Sofferenza IRCCS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of maternal deaths or venous thromboembolisms, hemorrhages (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.