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Набор скоро начнётся NCT06917833

Impact of Maternal Body Mass Index on Infant Hypoxic Events at Time of Delivery ,Cross-sectional Study.

— Наблюдательное Maternal Obesity Hypoxia Neonatal

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
В протоколе указаны: compare infant hypoxic events in both groups.
Кому может быть актуально
Состояния в реестре: Maternal Obesity, Hypoxia Neonatal. Базовые параметры: 18 лет — 40 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
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

Offspring from overweight or obese mothers appear to be at up to 38% increased risk of being admitted to the neonatal intensive care unit than the offspring of mothers with a normal BMI. In terms of Apgar scores at birth, babies of obese mothers have been reported to have a 31% excess risk of having a low Apgar score (defined at \<7 at 1 minute) . Infants born to obese mothers demonstrate a spectrum of outcomes, suggesting that there is a complex interplay of factors that defines the precise altered metabolic environment to which the fetus is exposed and that determines the risk of complications

Подробное описание

The investigators need to improve understanding of the specific molecular factors that contribute either individually or synergistically to detrimental fetal outcomes. Moreover, The investigators need to identify the essential maternal markers that need to be tightly regulated during pregnancy to improve outcomes. Here in, The investigators discuss the influence of maternal obesity and factors associated with the obesogenic intrauterine environment on fetal lung development and respiratory outcomes in offspring at birth importantly, The investigators identify a series of molecular changes encountered during pregnancy that may program the observed respiratory outcomes in clinical practice. The effects of maternal obesity on severe neonatal asphyxia may be partly explained by traumatic labor, which often results from macrosomia. Another consequence of maternal obesity is fetal hyperinsulinemia, which may be related to chronic hypoxia even without diabetes . Other mechanisms that explain the effect of maternal obesity on neonatal asphyxia include lipotoxicity, placental inflammation and vasculopathy, and cord coiling. Evidence has demonstrated altered gene expression in full-term newborns of mothers with obesity, involving dysregulation of brain development, inflammatory and immune signaling, glucose and lipid homeostasis, and oxidative stress

Вмешательства

  • Другое compare infant hypoxic events in both groups
    early neonatal resuscitation will be done by the pediatrician according to the guidelines, APGAR score of the baby will be calculated,, any hypoxic events will be traced and any need of respiratory support for the baby or NICU admission, as well as weight of the baby, mode of delivery and any birth traumas will be recorded.all this will be compared between two groups.

Первичные конечные точки

  • Rate of admission to neonatal observation room [Срок оценки: 6 hours post delivery]
Вторичные конечные точки (5)
  • Rate of cesarean-sections. [Срок оценки: 12 hours]
  • Oxygen saturation at birth. [Срок оценки: 2 hours post delivery]
  • Number of babies with NICU Admission. [Срок оценки: 6 hours post delivery]
  • Number of babies with birth trauma. [Срок оценки: 2 hours post delivery]
  • Number of babies with meconium aspiration. [Срок оценки: 2 hours post delivery]

Критерии участия

Критерии включения

  • Age of 18 - 40 years.
  • Term pregnancy (37 weeks gestation or more)
  • Singleton pregnancy
  • Cephalic presentation at time of delivery
  • In labour

Критерии исключения

  • Any medical disorders that affect neonatal outcomes (diabetes mellitus, hypertension, mixed connective tissue disorders)
  • Scarred uterus (myomectomy, previous cesarean section)
  • Macrosomic baby>4 kgs
  • Condition jeopardizing the maternal or fetal life (for example: antepartum hemorrhage, pathological CTG, cord prolapse)
  • Liquor abnormalities (oligohydramnios or polyhydramnios).
  • Other indications for cesarean sections for example: placenta accreta spectrum
  • Smokers.
  • Any abnormalities in follow up of delivery regarding partogram.

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.

Идентификаторы

NCT: NCT06917833 · MD344/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗