BridgeMD
Tests treatment safety and results for Pregnancy
Official title Effectiveness of a multicOmpoNent Behavioural intervenTion to Reduce endocrINe disrUptor Exposure During pErinatal Period (CONTINUE)
ClinicalTrials.gov ID: NCT07142447
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Pregnant women with a viable pregnancy confirmed by ultrasound until 13 weeks and 0 days of gestation (recruitment between 6-11 weeks). Their...
- 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
You likely can't join if
- 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.
See the full eligibility 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...
- 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
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Badalona, Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Badalona, Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.