Expert Consensus on the Use of Nutraceuticals in Pregnancy: A Delphi Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Nutraceuticals, Pregnancy. Basic parameters: from 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Primary outcome measures
- Primary Outcome [Time frame: 6-12 weeks]
Secondary outcome measures (1)
- Secondary outcome [Time frame: 6-12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Egypt · 1 center
- Venus Research Center — Cairo
Identifiers
NCT: NCT07296562 · Nutriceuticals in Pregnancy