Status:
RECRUITING
Effectiveness of a multicOmpoNent Behavioural intervenTion to Reduce endocrINe disrUptor Exposure During pErinatal Period (CONTINUE)
Lead Sponsor:
Fundació Institut Germans Trias i Pujol
Collaborating Sponsors:
KU Leuven
Universidad de Granada
Conditions:
Pregnancy
Children
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The general objective of HYPIEND is to understand the effects of chemical substances called "endocrine disruptors" (EDCs) during the perinatal and pre-pubertal stages. EDCs co-exposure may affect the ...
Detailed Description
Study rationale 1. Extent and evaluation of current knowledge directly linked to the scientific question(s) to be answered by the clinical study. Human epidemiological data suggest that EDC expos...
Eligibility Criteria
Inclusion
- Pregnant women with a viable pregnancy confirmed by ultrasound until 13 weeks and 0 days of gestation (recruitment between 6-11 weeks). Their partners will be invited to participate but this is not mandatory for inclusion.
- BMI at Visit 1 between 18.5-40 kg/m²
- Intention to breastfeed
- Being able to read the language of their respective countries (Dutch/French -Belgium-, Spanish and/or Catalan -Spain- and Polish -Poland)
- Being 18 years or older
- In possession of a smartphone. If participants do not have a smartphone because of socio-economic reasons, a smartphone will be at their disposal for the whole duration of the study
Exclusion
- Unable to sign informed consent (cultural barriers, psychological conditions)
- Abuse of substances (alcohol, drugs)
- Chronic use (at least, for three months before pregnancy) of any medication that might affect the HP axis:
- Antidepressants
- Insuline.
- Levothyroxine, Methimazole, Propylthiouracil.
- Oral corticosteroids (topical and inhalation formulations will be allowed)
- Arginine vasopressin (AVP)
- Mifepristone.
- Anticortisolic drugs: Metyrapone (Metopirone), Ketokonazole, Osilodrostat (Isturisa), Mitotane (Lysodren), aminoglutethimide (Cytadren) and Levoketoconazole (Recorlev).
- Multiple gestation
- Type 1 or 2 diabetes
- Pregnant women will not be consented into research by any HCP with whom they have a dependent relationship (Declaration of Helsinki) (I would remove this point).
Key Trial Info
Start Date :
February 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
810 Patients enrolled
Trial Details
Trial ID
NCT07142447
Start Date
February 24 2025
End Date
July 1 2027
Last Update
August 26 2025
Active Locations (1)
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1
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916