NCT07142447 Effectiveness of a multicOmpoNent Behavioural intervenTion to Reduce endocrINe disrUptor Exposure During pErinatal Period (CONTINUE)
| NCT ID | NCT07142447 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundació Institut Germans Trias i Pujol |
| Condition | Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 810 participants |
| Start Date | 2025-02-24 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 810 participants in total. It began in 2025-02-24 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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).
Contact & Investigator
Inés Velasco, MD, PhD
PRINCIPAL INVESTIGATOR
Foundation Institute of Research in Health Sciences Germans Trias i Pujol
Frequently Asked Questions
Who can join the NCT07142447 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07142447 currently recruiting?
Yes, NCT07142447 is actively recruiting participants. Contact the research team at ivelasco@igtp.cat for enrollment information.
Where is the NCT07142447 trial being conducted?
This trial is being conducted at Badalona, Spain.
Who is sponsoring the NCT07142447 clinical trial?
NCT07142447 is sponsored by Fundació Institut Germans Trias i Pujol. The principal investigator is Inés Velasco, MD, PhD at Foundation Institute of Research in Health Sciences Germans Trias i Pujol. The trial plans to enroll 810 participants.