Radiofrequency Electromagnetic Fields and Pregnancy : Exposure Specificities and Evolution (RFM - Expo)

December 3, 2024 updated by: Centre Hospitalier Universitaire de Besancon

Radiofrequency Electromagnetic Fields and Pregnancy : Exposure Specificities and Evolution: the RFM - Expo Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing the exposure of pregnant women to radiofrequencies
Time Frame: 3 days
Women have to wear a personal portable exposure meter during 3 days.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantifying the evolution of this exposure during pregnancy
Time Frame: 3 periods of 3 days
The measurement is repeted for each trimester of pregnancy
3 periods of 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

University of Basel
Swiss Tropical and Public Health Institute (Switzerland)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Estimated)

December 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024/923

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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