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Effectiveness of a multicOmpoNent Behavioural intervenTion to Reduce endocrINe disrUptor Exposure During pErinatal Period (CONTINUE)

RecruitingNAAges 18 Years - anyFemaleFundació Institut Germans Trias i Pujol
NCT07142447 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 function of hormones and determine endocrine consequences in vulnerable populations. The primary objective of this clinical study is to demonstrate that a multicomponent intervention implemented in health care centres from three European countries is effective in reducing the levels of EDCs in different body fluids of pregnant women, breastfeeding and formula feeding women as well as in their infants up to 18 months of age, improving at the same time the level of HAPA constructs (psychological determinants of behaviour) and the knowledge about these chemicals at family level.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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).
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What it tests

  • Multi-Component Behavioral intervention
  • Control group
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Where

1 site
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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