Radiofrequency Electromagnetic Fields and Pregnancy : Exp... | NCT06721481

Studies
Radiofrequency Electromagnetic Fields and Pregnancy : Exposure Specificities and Evolution

NCT06721481

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Not yet recruiting

Last Update Posted

Dec 6, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Radiofrequencies Exposure
Pregnancy
Real Life Study

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2024Estimated

Primary Completion Date

Mar 2026Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Dec 3, 2024

First Submission Date that Met QC Criteria

Dec 3, 2024

First Posted Date

Dec 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2024

Last Update Posted Date

Dec 6, 2024Actual

Name	Class
Swiss Tropical and Public Health Institute (Switzerland)	UNKNOWN
University of Basel	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant women		Pregnant women who attend their first prenatal consultation at the maternity ward of the University hospital of Besançon

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29754001	Background	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.