The main objective of the Brabant Study (BS) is to investigate possible different trajectories of thyroid function during pregnancy taking hCG hormone into account. Moreover, we aim to investigate whether pregnancy complications (e.g. pre-eclampsia…
ID
Source
Brief title
Condition
- Thyroid gland disorders
- Pregnancy, labour, delivery and postpartum conditions
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Thyroid hormone levels (TSH and fT4) and TPO-Ab and hCG assessed at 12, 20 and
28 weeks.
Secondary outcome
Pregnancy complications (e.g. pre-eclampsia, pre-term birth, SGA), mode of
delivery (spontaneous versus instrumental delivery) and depressive symptoms
related to thyroid trajectories and/or poor obstetric outcome.
Background summary
Adequate maternal thyroid function (thyrotropin (TSH) and free thyroid hormone
(fT4)) is extremely important during pregnancy for the developing foetus and is
subject to substantial physiological changes throughout gestation.
Cross-sectional measurements of TSH and fT4 have been related in many studies
to various obstetric outcomes including gestational diabetes, pre-eclampsia and
abnormal foetal position. Only few studies have observed an association between
outcomes and both TSH and fT4, whereas most others have reported a relationship
either with TSH but not fT4, or vice versa. Similarly, there are numerous
studies reporting a possible relation between thyroid dysfunction and
depression / depressive symptoms at a cross-sectional level and most of the
time for fT4 or TSH separately. LCA analyses recently showed new insights of
physiological thyroid function changes during pregnancy. However, the power of
these first LCA gestational thyroid function analyses was low and hCG
assessments (an important pregnancy hormone with major impact on thyroid
function as well) were not performed. Therefore, larger samples are needed in
order to compare the incidence of these complications between different
trajectories and TSH / fT4 should be adjusted for hCG. LCA has also been used
to report trajectories of depressive symptoms during pregnancy.
Study objective
The main objective of the Brabant Study (BS) is to investigate possible
different trajectories of thyroid function during pregnancy taking hCG hormone
into account. Moreover, we aim to investigate whether pregnancy complications
(e.g. pre-eclampsia, pre-term birth) and mode of delivery (spontaneous versus
instrumental delivery) are related to these trajectories. Also, we will
investigate whether trajectories of thyroid dysfunction are related to
depressive symptoms during pregnancy. Finally, the role of partner relationship
on pregnancy distress will be investigated and the possible role of distress on
absenteeism.
Study design
The current study is a longitudinal, prospective cohort study among 4000
pregnant women. They will be recruited among community midwife practices in
South-East Brabant in the Netherlands (Tilburg, Eindhoven and Den Bosch).
Study burden and risks
Participants will receive three questionnaires (15-20 minutes to complete) and
will provide three blood samples during pregnancy. The blood samples at 12 and
28 weeks are part of regular routine obstetric care, only the collection of an
additional tube of blood is needed. The blood sample at 20 weeks is an
additional burden for participants in this study. Moreover, the women will
receive a (optional) home visit or telephone interview, at 8-10 weeks
postpartum (lasting 1 hour).
No risks have been reported for the burden for the participants into the
current study: an additional blood assessment by vena-punction and completing
of questionnaires by the women.
Warandelaan 2
Tilburg 5037 AB
NL
Warandelaan 2
Tilburg 5037 AB
NL
Listed location countries
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64091.015.17 |