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Набор по приглашению NCT07296562

Expert Consensus on the Use of Nutraceuticals in Pregnancy: A Delphi Study

Наблюдательное Nutraceuticals 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Nutraceuticals, Pregnancy. Базовые параметры: от 25 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This study is a Delphi-based expert consensus project aimed at developing evidence-informed recommendations for the safe and effective use of nutriceuticals during pregnancy. Despite widespread use of vitamins, minerals, and other dietary supplements in prenatal care, significant variability exists in clinical practice regarding indications, dosing, timing, and safety monitoring.

Подробное описание

This study is a non-interventional, methodological Delphi consensus project designed to develop standardized recommendations for the use of nutriceuticals during pregnancy. Nutriceuticals, including vitamins, minerals, antioxidants, omega-3 fatty acids, and herbal supplements, are commonly used to support maternal health and fetal development. However, evidence regarding optimal dosing, timing, and safety profiles is inconsistent, and practice patterns vary globally.

A steering committee of experts in obstetrics, maternal-fetal medicine, and clinical nutrition will conduct a thorough literature review and draft initial statements addressing key domains:

Indications for nutriceutical use (routine supplementation, deficiency prevention, high-risk pregnancies)

Recommended dosing and timing for common nutriceuticals (folic acid, iron, vitamin D, iodine, omega-3 fatty acids, etc.)

Safety considerations and contraindications (including herbal and non-standard supplements)

Monitoring strategies for maternal and fetal safety

Integration with dietary and lifestyle interventions

Counseling and patient education

A panel of experts in obstetrics and maternal nutrition will participate in multiple Delphi rounds. Panelists will rate each statement on a Likert scale for agreement. After each round, anonymized feedback will be provided, and statements not reaching the predefined consensus threshold (e.g., ≥70-80%) will be revised for subsequent evaluation.

The final output will consist of consensus-based recommendations for nutriceutical use in pregnancy, highlighting areas of strong agreement, areas of uncertainty, and research priorities. These recommendations aim to support safe, evidence-informed clinical practice for maternal and fetal health.

Первичные конечные точки

  • Primary Outcome [Срок оценки: 6-12 weeks]
Вторичные конечные точки (1)
  • Secondary outcome [Срок оценки: 6-12 weeks]

Критерии участия

Критерии включения

  • Board-certified obstetricians, maternal-fetal medicine specialists, or clinical nutritionists with ≥5 years of relevant clinical experience.

Active involvement in prenatal care and experience or knowledge in nutriceutical use during pregnancy.

Engagement in clinical teaching, research, guideline development, or professional society activities related to maternal health or nutrition.

Willingness and availability to participate in all Delphi rounds.

Provision of informed consent to participate.

Критерии исключения

  • Non-obstetric or non-nutrition specialty.

Less than 5 years of relevant clinical experience.

Limited or no experience with nutriceutical counseling/prescribing in pregnancy.

Significant undisclosed conflict of interest related to nutriceutical products.

Inability or unwillingness to participate in all Delphi rounds.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Египет · 1 центр
  • Venus Research Center — Cairo

Идентификаторы

NCT: NCT07296562 · Nutriceuticals in Pregnancy

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗