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Effects of a Multiple Sclerosis Relapse Therapy on Offspring Neurocognitive Development and Behaviour

UnknownN/A

Sponsor: Jena University Hospital

Conditions: Multiple Sclerosis

Interventions: Exposure to methylprednisolone during pregnancy

Countries: Germany

Introduction: Fetal exposure to glucocorticoids (GCs) used to induce fetal lung maturation in women threatened by premature labour is known to induce aberrations in brain development and stress sensitivity, cognitive dysfunction and neuro-psychiatric disorders in later life which all predict early brain ageing. Another common source of fetal GC exposure is the treatment of relapses in multiple sclerosis (MS), the most common neurological disease in young women. Despite the lack of studies, the 300-fold higher dosage of GCs for MS relapse treatment compared to obstetric indications is considered harmless for the fetus . Objectives: To examine the effects of GCs for MS relapse treatment during pregnancy on offspring structural and functional brain development, stress sensitivity, and cognitive and behavioural performance. Methods: Epidemiological multi-centre cohort study in 80 children and adolescents aged 8 to 18 years whose mothers received GCs to treat a MS relapse during pregnancy compared to unexposed participants. Expected Impact: Creating a guideline-changing evidence-based risk-benefit assessment regarding benefits of the MS relapse therapy for the mother and potential harm to the child.

Eligibility overview

Sex: ALL

Age: 8 Years to 18 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* MS diagnosis was made based on the McDonald criteria valid at the time of diagnosis
* Written consent by the legal guardians of the participating child following a detailed oral and written education
* Exposed group (n=40): Children and adolescents (aged 8 to 18 years) of mothers with prenatal exposition to MP in the context of a MS relapse therapy
* Non-exposed group (n=40): Children and adolescents of mothers suffering from MS without MP therapy during pregnancy (aged 8 to 18 years) matched for age, gender and social background

Exclusion Criteria:

* Perinatal complications such as cerebral bleeding, neonatal intensive care with ventilation, prenatal therapy with glucocorticoids except for an MS relapse
* Maternal abuse of noxious agents during pregnancy
* Long-term glucocorticoid medication (e.g. asthma)
* Preterm births (before 36 weeks of pregnancy)
* Severe disease making an examination impossible (e.g. mental retardation)
* disease-modifying therapy during pregnancy

Locations (2)

Bochum, Germany
Jena, Germany