Skip to content

HAPPY-follow: Longitudinal follow-up of mothers and children of the HAPPY study (Holistic Approach to Pregnancy and first Postpartum Year)

HAPPY-follow: Longitudinal follow-up of mothers and children of the HAPPY study (Holistic Approach to Pregnancy and first Postpartum Year) - HAPPY-follow

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42645
Enrollment
1100
Registered
2015-10-06
Start date
2015-10-21
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

developmental delay

Interventions

None listed

Sponsors

Maxima Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)