Fetal AnemiaNCT07551232
Evaluation of Myocardial Performance Index in Cases of Fetal Anemia: A Prospective Study
An observational study of Fetal Anemia and Fetal Echocardiography, run by Assiut University.
Trial summary
To Evaluation of myocardial performance index in cases of fetal anemia Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fetal Anemia, Fetal Echocardiography
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Singleton pregnancy with raised MCA PSV MOM due to alloimmunization or Parvovirus infection will be invited to participate in the study. Institutional ethics committee approval will be gained and all women who participate in the study will gave an informed consent
Inclusion Criteria:Singleton pregnancy with raised MCA PSV MOM due to alloimmunization or Parvovirus infection will be invited to participate in the study.Institutional ethics committee approval will be gained and all women who participate in the study will gave an informed consent.
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Exclusion Criteria:fetuses with structural or chromosomal anomalies, maternal systemic diseases (e.g., cardiac disease, respiratory disease, sever maternal coagulopathy),and cases in which technically reliable Mod-MPI measurements could not be obtained as obese women.. Active maternal infection at puncture site.
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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To Evaluation of myocardial performance index in cases of fetal anemia
Read the detailed description
. Fetal anemia is a relatively rare but serious condition. An immune-related cause is most common, involving red-blood-cell (RBC) alloimmunization, followed by non-immune causes, such as parvovirus B19 infection and, more rarely, hemoglobinopathies, fetomaternal hemorrhage (FMH) and monochorionic twin complications, among others. Several advances have been made in the diagnosis and treatment of fetal anemia. High-resolution ultrasound now permits accurate, non-invasive screening by measurement of the middle cerebral artery peak systolic velocity (MCA-PSV) replacing serial amniocenteses for fetal anemia screening.
Severe fetal anemia may be associated with progressive loss of adaptive mechanisms because of inadequate tissue oxygenation. Ultimately, metabolic changes result in fetal acidosis and increased perinatal morbidity and mortality. Although cardiac decompensation does not seem to be the principal mechanism involved in the development of overt fetal hydrops, severe anemia may lead to cardiac ischemia, reduced contractility, and dysfunction.
Myocardial performance index (MPI) is a noninvasive technique that evaluates systolic and diastolic cardiac function by pulsed Doppler. Fetal MPI evaluation was originally described by Tsutsumi et al., and several studies have subsequently shown that it is a simple and reproducible technique. Significant changes in fetal MPI have been demonstrated in twin-twin transfusion syndrome recipient fetuses, intrauterine growth restriction, diabetes, and fetal inflammatory response syndrome The introduction of intrauterine transfusion (IUT) has dramatically improved survival, particularly in cases of red cell alloimmunization and parvovirus B19 infection.
However, access to IUT is limited in many low- and middle-income settings. In such environments, clinicians rely primarily on non-invasive diagnostic tools, particularly middle cerebral artery peak systolic velocity (MCA-PSV) Doppler assessment.
- Conditions
- Fetal Anemia, Fetal Echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing Mod-MPI as integrated additional monitoring parameter aim to reach decision making in cases of fetal anemia
Middle cerebral artery, MPI
Measured: may 2026-May 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fetal AnemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551232
- Sponsor's protocol ID
- Fetal anemia and MPI
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moise KJ Jr, Abels EA. Management of Red Cell Alloimmunization in Pregnancy. Obstet Gynecol. 2024 Oct 1;144(4):465-480. doi: 10.1097/AOG.0000000000005709. Epub 2024 Aug 15.
PubMed 39146538Hernandez-Andrade E, Lopez-Tenorio J, Figueroa-Diesel H, Sanin-Blair J, Carreras E, Cabero L, Gratacos E. A modified myocardial performance (Tei) index based on the use of valve clicks improves reproducibility of fetal left cardiac function assessment. Ultrasound Obstet Gynecol. 2005 Sep;26(3):227-32. doi: 10.1002/uog.1959.
PubMed 16116562Babkova A, Rob L, Kubecova M, Hruda M, Halaska MJ. Middle cerebral artery peak systolic velocity monitoring of fetal anemia during chemotherapy in pregnancy. Acta Obstet Gynecol Scand. 2024 Apr;103(4):660-668. doi: 10.1111/aogs.14759. Epub 2024 Jan 16.
PubMed 38226422Arslanoglu T, Bilirer KK, Uludag S, Arslan HC, Cetinkaya M, Dane BK, Polat I. The role of the Mod-MPI in identifying cardiac dysfunction in FGR fetuses stratified by umbilical artery flow abnormalities. BMC Pregnancy Childbirth. 2025 Sep 18;25(1):937. doi: 10.1186/s12884-025-08120-y.
PubMed 40968360
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Myocardial Performance Index in Cases of Fetal Anemia: A Prospective Study
- ClinicalTrials.gov ID
- NCT07551232
- Acronym / sponsor ID
- Fetal anemia and MPI
- Conditions
- Fetal Anemia, Fetal Echocardiography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 24 Apr 2026 (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.
To Evaluation of myocardial performance index in cases of fetal anemia
Detailed description
. Fetal anemia is a relatively rare but serious condition. An immune-related cause is most common, involving red-blood-cell (RBC) alloimmunization, followed by non-immune causes, such as parvovirus B19 infection and, more rarely, hemoglobinopathies, fetomaternal hemorrhage (FMH) and monochorionic twin complications, among others. Several advances have been made in the diagnosis and treatment of fetal anemia. High-resolution ultrasound now permits accurate, non-invasive screening by measurement of the middle cerebral artery peak systolic velocity (MCA-PSV) replacing serial amniocenteses for fetal anemia screening.
Severe fetal anemia may be associated with progressive loss of adaptive mechanisms because of inadequate tissue oxygenation. Ultimately, metabolic changes result in fetal acidosis and increased perinatal morbidity and mortality. Although cardiac decompensation does not seem to be the principal mechanism involved in the development of overt fetal hydrops, severe anemia may lead to cardiac ischemia, reduced contractility, and dysfunction.
Myocardial performance index (MPI) is a noninvasive technique that evaluates systolic and diastolic cardiac function by pulsed Doppler. Fetal MPI evaluation was originally described by Tsutsumi et al., and several studies have subsequently shown that it is a simple and reproducible technique. Significant changes in fetal MPI have been demonstrated in twin-twin transfusion syndrome recipient fetuses, intrauterine growth restriction, diabetes, and fetal inflammatory response syndrome The introduction of intrauterine transfusion (IUT) has dramatically improved survival, particularly in cases of red cell alloimmunization and parvovirus B19 infection.
However, access to IUT is limited in many low- and middle-income settings. In such environments, clinicians rely primarily on non-invasive diagnostic tools, particularly middle cerebral artery peak systolic velocity (MCA-PSV) Doppler assessment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Singleton pregnancy with raised MCA PSV MOM due to alloimmunization or Parvovirus infection will be invited to participate in the study. Institutional ethics committee approval will be gained and all women who participate in the study will gave an 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.
Primary outcome
Testing Mod-MPI as integrated additional monitoring parameter aim to reach decision making in cases of fetal anemia
Time frame: may 2026-May 2028
Middle cerebral artery, MPI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Results publication: PubMed 39146538Moise KJ Jr, Abels EA. Management of Red Cell Alloimmunization in Pregnancy. Obstet Gynecol. 2024 Oct 1;144(4):465-480. doi: 10.1097/AOG.0000000000005709. Epub 2024 Aug 15.
- Results publication: PubMed 16116562Hernandez-Andrade E, Lopez-Tenorio J, Figueroa-Diesel H, Sanin-Blair J, Carreras E, Cabero L, Gratacos E. A modified myocardial performance (Tei) index based on the use of valve clicks improves reproducibility of fetal left cardiac function assessment. Ultrasound Obstet Gynecol. 2005 Sep;26(3):227-32. doi: 10.1002/uog.1959.
- Results publication: PubMed 38226422Babkova A, Rob L, Kubecova M, Hruda M, Halaska MJ. Middle cerebral artery peak systolic velocity monitoring of fetal anemia during chemotherapy in pregnancy. Acta Obstet Gynecol Scand. 2024 Apr;103(4):660-668. doi: 10.1111/aogs.14759. Epub 2024 Jan 16.
- Results publication: PubMed 40968360Arslanoglu T, Bilirer KK, Uludag S, Arslan HC, Cetinkaya M, Dane BK, Polat I. The role of the Mod-MPI in identifying cardiac dysfunction in FGR fetuses stratified by umbilical artery flow abnormalities. BMC Pregnancy Childbirth. 2025 Sep 18;25(1):937. doi: 10.1186/s12884-025-08120-y.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Anemia and Fetal Echocardiography, run by Assiut University.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naglaa mohammad, Assisatant lecturer (2001068119290, Naglaa.20134418@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing Mod-MPI as integrated additional monitoring parameter aim to reach decision making in cases of fetal anemia (time frame: may 2026-May 2028). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07551232, which also lists 4 linked publications.
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 24 Apr 2026.