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Идёт набор NCT06155344

Vegetalization of the Maternal Diet During Pregnancy: Association With Pregnancy Outcomes and Newborn Health.

— Наблюдательное Diet During Pregnancy

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: Food Frequency Questionnaire, Collection of 4 mL maternal blood.
Кому может быть актуально
Состояния в реестре: Diet During Pregnancy. 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

VEGALIM : Vegetalization of the Maternal Diet During Pregnancy: Association With Pregnancy Outcomes and Newborn Health.

Обзор

Reducing consumption of foods of animal origin in favor of more plant-based diets is a major environmental, public health and economic challenge. Data on the health effects of highly vegetalized diets are available only in adults. Few studies report the effect of the level of vegetalization of the maternal diet during pregnancy on the mother's health, and the development and health of the child. The VEGALIM project aims to describe the level of vegetalization of pregnant women's diets and the nutritional quality of their diets early in pregnancy (first trimester) and late pregnancy, and to explore the potential effects on their plasma lipid profile that may impact on their health during pregnancy and the health of the newborn.

Вмешательства

  • Другое Food Frequency Questionnaire
    We will obtain a global index of vegetalization of the diet (the Plant based Diet Index: PDI) from data obtained using semi-quantitative questionnaires on food frequency (Food Frequency Questionnaire (FFQ)) validated on the national ELFE cohort (French Longitudinal Study from Childhood (https://www.elfe-france.fr)) and completed by women in the 1st trimester of pregnancy (T1) and at delivery.
  • Другое Collection of 4 mL maternal blood
    One tube collection of 4 mL maternal blood in the first trimester and at delivery.

Первичные конечные точки

  • Characterizing the levels of plant-based food consumption at the beginning of pregnancy (at the end of the first trimester of pregnancy) based on the completion of the Food Frequency Questionnaire (FFQ, scale from 0 to 6 ; 0 being the worst outcome) [Срок оценки: 25 minutes]
Вторичные конечные точки (10)
  • Study the evolution of the vegetation score between the 1st and 3rd trimester of pregnancy [Срок оценки: 6 months]
  • Study changes in diet quality between the 1st and 3rd trimesters of pregnancy [Срок оценки: 6 months]
  • Studying the association between vegetarian diets in the first trimester of pregnancy and pregnancy outcomes (such as prematurity, birth weight, maternal pathologies not present at the time of inclusion (gestational diabetes, pre-eclampsia, etc.). [Срок оценки: 6 months]
  • Study the association between diet quality in the first trimester of pregnancy and pregnancy outcomes (such as prematurity, birth weight, maternal pathologies not present at the time of inclusion (gestational diabetes, pre-eclampsia, etc.). [Срок оценки: 6 months]
  • Study the association between the vegetalization of the diet and the lipid profile of women in the 1st trimester and at childbirth. [Срок оценки: 6 months]
  • Study the association between diet quality and lipid profiles of women in the 1st trimester and at childbirth. [Срок оценки: 6 months]
  • Study the association between the vegetalization of the diet and the total fatty acid status of women in the 1st trimester and at childbirth. [Срок оценки: 6 months]
  • Study the association between diet quality and total fatty acid status in women at 1st trimester and at childbirth. [Срок оценки: 6 months]
  • Identify other biological markers, such as vitamins, that may be impacted by a change in diet, and study the influence of diet quality on these potential plasma markers of patient and of Umbilical cord blood plasma. [Срок оценки: 6 months]
  • Study the association between diet quality and the lipid profile of umbilical cord blood at delivery (T3). [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Pregnant women consulting the CEMAFOER at the Nantes University Hospital for pregnancy monitoring
  • Gestational age between 11 and 13 AW +6 days
  • Understanding French

Критерии исключения

  • Patients under 18 years of age
  • Patient who objected to being included in the study
  • Patient with cognitive problems that prevent her from answering questionnaires

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • CHU de Nantes — Nantes

Идентификаторы

NCT: NCT06155344 · RC23_0399 · 2023-A01997-38

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗