- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07551232
Evaluation of Myocardial Performance Index in Cases of Fetal Anemia: A Prospective Study
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Naglaa mohammad, Assisatant lecturer
- Phone Number: 2001068119290
- Email: Naglaa.20134418@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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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Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Testing Mod-MPI as integrated additional monitoring parameter aim to reach decision making in cases of fetal anemia
Time Frame: may 2026-May 2028
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Middle cerebral artery, MPI
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may 2026-May 2028
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Hernandez-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.
- Babkova 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.
- Arslanoglu 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Fetal anemia and MPI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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