The Brabant Study: a prospective cohort study among pregnant wome
Completed
- Conditions
- thyroid dysfunction during pregnancy100437391001027310027946
- Registration Number
- NL-OMON52874
- Lead Sponsor
- niversiteit van Tilburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4000
Inclusion Criteria
- Pregnant women (18+ y) who have their first antenatal visit < 14 weeks
- Dutch or English-speaking or understanding Dutch or English
Exclusion Criteria
- Multiple pregnancy
- Known endocrine disorder before pregnancy
- Use of thyroid medication
- Severe psychiatric disease (e.g. schizophrenia, borderline, bipolar disorder
or depression with known suicidal ideation)
- HIV
- Drug or alcohol addiction problems
- Any other disease resulting in treatment with drugs that are potentially
adverse for the foetus and need careful follow-up during pregnancy (e.g. Type 2
Diabetes with use of insulin, Rheumatoid Arthritis with use of prednison or
methotrexate, Multiple Sclerosis or Crohn's disease).
- No access to internet
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p> Thyroid hormone levels (TSH and fT4) and TPO-Ab and hCG assessed at 12, 20 and<br /><br>28 weeks.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pregnancy complications (e.g. pre-eclampsia, pre-term birth, SGA), mode of<br /><br>delivery (spontaneous versus instrumental delivery) and depressive symptoms<br /><br>related to thyroid trajectories and/or poor obstetric outcome.</p><br>