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

NCT ID: NCT07296562

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-25

Study Completion Date

2027-09-01

Brief Summary

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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

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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.

Conditions

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Nutraceuticals Pregnancy

Keywords

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nutraceuticals Pregnancy Maternal Health Fetal Health Consensus Delphi

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Expert Panel

The study population will consist of a purposive sample of experts in obstetrics, maternal-fetal medicine, and clinical nutrition who are actively involved in the care of pregnant patients and have experience or knowledge regarding the use of nutriceuticals in pregnancy.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Venus Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Venus Research Center

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Nutriceuticals in Pregnancy

Identifier Type: -

Identifier Source: org_study_id