Radiofrequency Electromagnetic Fields and Pregnancy : Exposure Specificities and Evolution

NCT06721481 | Not Yet Recruiting

• 1 other identifier: 2024/923
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the specific features of radiofrequencies (RF) exposure (including 5G) in pregnant women, its evolution during pregnancy and the quantitative contribution of the various RF emission sources to which they are exposed.

Conditions

Radiofrequencies Exposure; Pregnancy; Real Life Study

Keywords

radiofrequencies; exposure science; exposure meter; 5G

Outcome Measures

Primary Outcomes (1)

• Assessing the exposure of pregnant women to radiofrequencies

  Women have to wear a personal portable exposure meter during 3 days.

  3 days

Secondary Outcomes (1)

• Quantifying the evolution of this exposure during pregnancy

  3 periods of 3 days

Study Arms (1)

Pregnant women

Pregnant women who attend their first prenatal consultation at the maternity ward of the University hospital of Besançon

Eligibility Criteria

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

Study Population

1,500 pregnant women having their first prenatal ultrasound visit at the maternity ward of the Besançon University Hospital

You may qualify if:

• Pregnant women over 18 years of age;
• Subject not opposed to participating in the study;
• Patient performing the three screening ultrasounds recommended by the French National Authority for Health (HAS) at the Universitary hospital of Besançon during her pregnancy (independently or in addition to on-site clinical pregnancy monitoring); Affiliation with a French social security scheme or beneficiary of such a scheme; Living within the Universitary hospital of Besançon maternity catchment area, to cover the full range of geographical exposure, including both highly urbanized and more rural areas;

You may not qualify if:

• Opposition of the subject to participate in the study;
• Discontinuation of pregnancy ultrasound follow-up at Besançon University Hospital, in particular due to relocation;
• Women under court protection, guardianship, curatorship or protective supervision.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Swiss Tropical and Public Health Institute (Switzerland): collaborator
• University of Basel: collaborator

Related Publications (1)

• Birks LE, Struchen B, Eeftens M, van Wel L, Huss A, Gajsek P, Kheifets L, Gallastegi M, Dalmau-Bueno A, Estarlich M, Fernandez MF, Meder IK, Ferrero A, Jimenez-Zabala A, Torrent M, Vrijkotte TGM, Cardis E, Olsen J, Valic B, Vermeulen R, Vrijheid M, Roosli M, Guxens M. Spatial and temporal variability of personal environmental exposure to radio frequency electromagnetic fields in children in Europe. Environ Int. 2018 Aug;117:204-214. doi: 10.1016/j.envint.2018.04.026. Epub 2018 May 10.

  PMID: 29754001 BACKGROUND

Central Study Contacts

Sophie Pujol, PhD

CONTACT

+33 3 81 21 90 49; spujol@chu-besncon.fr

Frédéric Mauny, Professor

CONTACT

++33 3 81 21 94 94; frederic.mauny@univ-fcomte.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: November 30, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share