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Cardiac Functions as a New Method for Evaluation of Fetal Anemia Pre and Post Intrauterine Fetal Blood Transfusion

NCT03169907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-04-09

No results posted yet for this study

Summary

INTRODUCTION

Circulatory changes associated with fetal anemia have an important role in maintaining sufficient tissue oxygenation. With fetal anemia, hyperdynamic circulation and increased cardiac output occurred. In current practice, using Doppler in assessment of the peak systolic velocity (PSV) of the middle cerebral artery (MCA) is the main parameter in screening of fetal anemia. Myocardial performance index (MPI) is a noninvasive technique that evaluates systolic and diastolic cardiac function by pulsed Doppler.

Patients and Methods:

This prospective study will be carried out on Women with singleton pregnancies with Rh isoimmunization who are scheduled to have intrauterine blood transfusion. Selected patients will be monitored weekly from 18 weeks gestational age till 28 weeks of gestational age.

Venous and arterial Doppler indices:

1. Middle cerebral artery (MCA) peak systolic velocity (PSV)
2. Umbilical Artery Pulsitility Index (PI) and Resistant Index (RI)
3. Ductus venosus (DV) Doppler

Cardiac functions:

1. Global cardiac function evaluated by Modified Myocardial Performance Index (Mod-MPI)
2. Diastolic cardiac function evaluated by relationship between the maximal velocities of the E and A waveforms of ventricular filling (E/A ratio)

Conditions

  • Fetal Anemia as Antepartum Condition (Diagnosis)
  • Rh Incompatible Blood Transfusion Nos

Interventions

RADIATION

Mid trimesteric fetal ultrasonography

Venous and arterial Doppler indices: 1. Middle cerebral artery (MCA) peak systolic velocity (PSV): 2. Umbilical Artery Pulsitility Index (PI) and Resistant Index (RI): 3. Ductus venosus (DV) Doppler: Cardiac functions: 1. Global cardiac function evaluated by Modified Myocardial Performance Index (Mod-MPI): 2. Systolic cardiac function using the four-dimensional (4D) spatiotemporal imaging correlation (STIC) ultrasound technique: 3. Diastolic cardiac function evaluated by relationship between the maximal velocities of the E and A waveforms of ventricular filling (E/A ratio)

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • National Research Centre, Egypt

    lead OTHER

Principal Investigators

  • Ahmad Z El Sheikhah, Professor · Professor of Obstetrics and Gynecology, Cairo Fetal Medicine Unit, Cairo University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Weeks
Max Age
28 Weeks
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2018-04-01
Completion
2019-04-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03169907 on ClinicalTrials.gov