Expert Consensus on the Use of Nutraceuticals in Pregnancy: A Delphi Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Primary Outcome
时间窗: 6-12 weeks
Level of expert consensus on statements regarding nutraceutical use in pregnancy, measured as the proportion of panelists reaching the predefined agreement threshold (e.g., ≥70-80%) for each statement across Delphi rounds.
次要结局
- Secondary outcome(6-12 weeks)