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Идёт набор NCT07258329

Screening for Intrapartum Fetal Compromise Using Placental Biomarkers

Наблюдательное Pregnant Women

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: Pregnant Women. Базовые параметры: от 18 лет · 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Screening Della Compromissione Fetale Intrapartum Mediante Utilizzo Dei Marcatori Placentari

Обзор

This study aims to investigate the association between placental markers (sFlt-1, PlGF, and the sFlt-1/PlGF ratio) and intrapartum fetal compromise, assessed on the basis of the cardiotocographic tracing.

Подробное описание

The development of placentation during pregnancy involves two simultaneous processes: the invasion of maternal spiral arteries by cytotrophoblasts and the branching of the fetal vascular tree. These mechanisms, regulated by factors such as VEGF, PlGF, sFlt-1, and PAPP-A, ensure an adequate supply of oxygen and nutrients to the fetus. When these processes are impaired, placental dysfunction develops, characterized by high vascular resistance, hypoperfusion, and oxidative stress, which can predispose to complications such as preeclampsia, fetal growth restriction, gestational diabetes, placental abruption, and preterm birth.

During labor, uterine contractions can reduce uteroplacental perfusion by up to 60%. A healthy fetus with a normally functioning placenta can tolerate these transient reductions through compensatory mechanisms, whereas a fetus with abnormal placentation may exhibit signs of compromise, such as abnormal heart rate patterns or the presence of meconium, and, in cases of severe hypoxia, may face more serious risks.

The clinical challenge is to identify, before labor, fetuses that, despite appropriate growth, have a placenta unable to withstand the stress of delivery. Some studies have investigated Doppler velocimetry, particularly the Cerebro-Placental Ratio, but its predictive ability at term is modest. The role of placental markers (PlGF, sFlt-1, sFlt-1/PlGF) in predicting intrapartum fetal compromise also remains uncertain, with conflicting results reported in the literature. Since these markers are altered in pregnancies with placental dysfunction, their combination with antenatal risk factors may allow better identification of fetuses at risk, guiding clinicians in labor management and the choice of delivery mode.

This study will enroll participants using a retrospective and prospective approach. The primary aim is to evaluate the association between placental markers and intrapartum fetal compromise based on cardiotocographic tracings. Secondary aims include assessing their relationship with fetal acidosis, low Apgar scores, and admission to the neonatal intensive care unit.

Первичные конечные точки

  • Number of Participants Diagnosed with Intrapartum Fetal Compromise Based on Cardiotocographic Tracing [Срок оценки: At the time of delivery]
Вторичные конечные точки (3)
  • Number of Participants With Fetal Acidosis (pH ≤ 7.0 or Base Excess ≥ -12) [Срок оценки: At the time of delivery]
  • Number of Participants With 5-Minute Apgar Score < 7 [Срок оценки: At the time of delivery]
  • Number of Newborns Transferred to Neonatal Intensive Care Unit (NICU) for Birth-Related Hypoxia [Срок оценки: At the time of delivery]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Gestational age ≥ 32 weeks
  • Obtaining informed consent for participation in the study and for the processing of personal data
  • Pregnant patients with an indication to perform placental marker testing as part of routine clinical practice
  • Patients who will deliver at the Obstetrics Units of the participating centers

Критерии исключения

\- Absolute contraindications to vaginal delivery (placenta previa, vasa previa, placenta accreta, previous myomectomy)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Италия · 2 центра
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
  • IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan

Идентификаторы

NCT: NCT07258329 · PLGF_IFC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗