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Набор скоро начнётся NCT07551232

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

— Наблюдательное Fetal Anemia Fetal Echocardiography

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Fetal Anemia, Fetal Echocardiography. Базовые параметры: Без ограничений · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

To Evaluation of myocardial performance index in cases of fetal anemia

Подробное описание

. 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.

Первичные конечные точки

  • Testing Mod-MPI as integrated additional monitoring parameter aim to reach decision making in cases of fetal anemia [Срок оценки: may 2026-May 2028]

Критерии участия

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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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • 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. PMID 39146538
  • 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. PMID 16116562
  • 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. PMID 38226422
  • 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. PMID 40968360

Идентификаторы

NCT: NCT07551232 · Fetal anemia and MPI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗