The primary objectives :Are children of mothers with sub-optimal thyroid function and/or sub-clinical hypothyroidism and/or hypothyroxinemia during early pregnancy at risk for developmental delay at the age of two and does this possible delay…
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
We will compare developmental scores of children of mothers with and without
maternal thyroid dysfunction during gestation and of mothers with and of
mothers with and without depression during pregnancy and the post-partum.
Moreover, we will compare ultrasound data at 20 weeks gestation (cerebellum
size, ventricle size and bi-parietal diameter) in the thyroid group and the
healthy controls, possibly correlating thyroid function to CNS parameters.
Secondary outcome
N/A
Background summary
During the HAPPY study (Holistic Approach to Pregnancy and first Postpartum
Year) 2250 pregnant women have been included in a longitudinal study in
2013-2014. During pregnancy maternal thyroid function and maternal mood were
monitored. Maternal thyroid function is essential for the development of the
central nervous system of the fetus which until 20 weeks does not produce
thyroid hormone. Furthermore, a standardized 20 weeks ultrasound has been
conducted during which several parameters of the central nervous system (CNS)
have been collected: cerebellum size, ventricle size and bi-parietal diameter.
At 12, 24 and 32 weeks symptoms of depression were assessed. With the data we
collected, we were able to construct a vulnerability profile for women who are
vulnerable to (recurrent) depression.
Study objective
The primary objectives :
Are children of mothers with sub-optimal thyroid function and/or sub-clinical
hypothyroidism and/or hypothyroxinemia during early pregnancy at risk for
developmental delay at the age of two and does this possible delay persist at
preschool age (3.5 years of age)?
Are children of mothers with recurrent depression during pregnancy at risk for
developmental delay at the age of two and does this possible delay persist at
preschool age (3.5 years of age)?
The secondary objectives :
Is there any correlation between developmental delay of children of mothers
with sub-optimal thyroid function during gestation and CNS parameters
(cerebellum size, ventricle size, bi-parietal diameter), assessed at 20 weeks
gestation on ultrasound?
Is early recognition of developmental problems in children followed by referral
to usual care associated with better developmental scores at further follow-up?
Study design
Observational study with two assessments.
Study burden and risks
The Bayley-III-NL is a playful test that is usually enjoyed by children. The
benefit for the child of doing this test is that developmental delays can be
detected at an early age and that the child and parents can be supported in
coping with and/or overcoming the developmental delay.
There is no risk associated with the Bayley-III-NL test.
De run 4600
Veldhoven 5504DB
NL
De run 4600
Veldhoven 5504DB
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, mothers who participated in the HAPPY study and their children that were born during the HAPPY study must meet the following criteria:
• 200 mothers with recurrent depressive symptoms during pregnancy and their (200) children. Within HAPPY there were 3 assessments of depression during pregnancy, and five during postpartum. Recurrent depression is defined as an EDS score above cut-off at three consecutive assessment during pregnancy and/or at least three times an EDS above the cut-off during the 12 months postpartum follow-up.
• 150 mothers with sub-optimal thyroid function (elevated TPO-Ab titres; 8.8% of 1353 women = 119) and /or sub-clinical hypothyroidism (TSH > 90th percentile = 135 women) and / or hypothyroxinemia. (FT4 < 10th percentile = 135 women) and their children (150). Because of substantial overlap between elevated TPO-Ab titres and high TSH women, a conservative estimation result in 150 women (and their children) who meet one or more of these criteria. If the sample of women who meet these criteria is higher than 150, SPSS will give a random selected sample.
• A control group of 200 mothers who did not have elevated depression scores during pregnancy, with thyroid function within trimester specific reference limits (between 25th and 75th percentile), not suffering from chronic conditions, and their children.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Hospitalization in a psychiatric hospital in the previous 12 months
- A known serious psychiatric disease diagnosis (bi-polar disorder,
psychotic depression, personality disorder) at the time of the home visit
- Severe depression with suicidal ideation during home visit
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 | NL54558.015.15 |