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

NCT07296562 | Enrolling By Invitation

• 1 other identifier: Nutriceuticals in Pregnancy
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nutraceuticals; Pregnancy

Keywords

nutraceuticals; Pregnancy; Maternal Health; Fetal Health; Consensus; Delphi

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  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.

  6-12 weeks

Secondary Outcomes (1)

• Secondary outcome

  6-12 weeks

Study Arms (1)

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.

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

he study population will consist of a purposive sample of experts in obstetrics, maternal-fetal medicine, and clinical nutrition who are actively involved in prenatal care and have experience or knowledge regarding the use of nutriceuticals in pregnancy. Panel Size and Rationale: Target enrollment: 20-35 experts. Sufficient to capture diverse perspectives while remaining feasible for multiple Delphi rounds. Minimum for analysis: 15 panelists, ensuring representativeness in case of attrition.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Venus Research Center: lead

Study Sites (1)

Venus Research Center

Cairo, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 22, 2025
• Study Start: January 25, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)