major congenital malformations, spontaneous abortions, fetal death, prematurity, poor neonatal adaptation, gestational diabetes, polyhydramnios, fetal growth
Conditions
Interventions
Group 1: Observational cohort study: Documented pregnancies based on data from the Embryotox cohort (observation period: 01.01.2000-31.03.2025)
Arm 1 study cohort (lithium-exposed): Approximately 420
Sponsors
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: At the time of initial contact with the PVZ Embryonaltoxikologie, the outcome of the pregnancy is unknown and there are no pathological findings at this point of time. Contact with the PVZ Embryonaltoxikologie for drug counseling during pregnancy during the specified study period 01.01.2000 to 31.3.2025. Information on the pregnancy outcome is available; the quality of the information/data must meet internal standards.
Exclusion criteria
Exclusion criteria: Exclusion criteria: • Exclusion of cases with maternal exposure considered as potent teratogens or fetotoxicants: i.e. acenocoumarol, ACE-inhibitors and ARBs (AT1-antagonists), carbamazepine, lenalidomide, methotrexate, misoprostol with the indication elective termination of pregnancy, mycophenolate, phenobarbital, phenprocoumon, phenytoin, retinoids (acitretin, adapalene, alitretinoin, isotretinoin, tazarotene, tretinoin, trifarotene), thalidomide, topiramate, valproic acid, warfarin. • Exclusion of cases with the following treatment indication: Malignancies, Malignancy related conditions • Exclusion of cases with only non-therapeutical lithium exposure, e.g. environmental lithium exposure via drinking water
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Does the use of lithium during the first trimester increase the rate of major congenital malformations, particularly cardiac malformations, compared to control groups not exposed to lithium? 2. Does the use of lithium during the first trimester increase the rate of spontaneous abortions and fetal death compared to control groups not exposed to lithium? | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Does treatment with lithium during pregnancy increase the risk of negative effects on the child's outcome, such as prematurity and poor neonatal adaptation? 2. Does treatment with lithium during pregnancy increase the risk of pregnancy complications such as gestational diabetes or polyhydramnios? 3. Is there a dose-dependent effect on the risk of malformations and fetal growth? | — |
Countries
Germany
Contacts
Public ContactAriane Wahliß
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie
Outcome results
None listed