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

Venus Research Center

Status: Invitation-only

Conditions: Nutraceuticals; Pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT07296562

Nutriceuticals in Pregnancy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

15 participants in 1 patient group

Expert Panel

Description:

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.