Evaluation of Myocardial Performance Index in Cases of Fetal Anemia: A Prospective Study

April 20, 2026 updated by: Naglaa Mohamed, Assiut University
To Evaluation of myocardial performance index in cases of fetal anemia

Study Overview

Status

Not yet recruiting

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

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Middle cerebral artery, MPI
may 2026-May 2028

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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