Behavioral Intervention to Reduce Chemical Exposure in Pregnancy
Effectiveness of a multicOmpoNent Behavioural intervenTion to Reduce endocrINe disrUptor Exposure During pErinatal Period (CONTINUE)
Recruiting
N/AInterventional Study
PregnancyChildren
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Prevention
Participants needed
810 (estimated)
Sponsor
Fundació Institut Germans Trias i Pujol · Other
Who this trial is looking for
This trial is looking for pregnant women who want to learn about reducing chemical exposure during pregnancy and after childbirth. Participants will engage in a program aimed at lowering harmful chemicals while receiving support and information.
Are You a Good Fit for This Trial?
Must not be takingAntidepressantsInsulinLevothyroxineMethimazolePropylthiouracilOral corticosteroids
You may be able to join if
I am pregnant and have a viable pregnancy confirmed by ultrasound.
I plan to breastfeed.
I can read Dutch, French, Spanish, Catalan, or Polish.
I am at least 18 years old.
I have a smartphone or can borrow one for the study.
My BMI is between 18.5 and 40.
I am between 6 and 11 weeks pregnant.
You may not be able to join if
I cannot sign informed consent.
I have a substance abuse issue.
I have been taking certain medications that affect hormones.
I am pregnant with twins or more.
I have type 1 or type 2 diabetes.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
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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 h…
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.
Trial Locations
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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 …
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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