Pregnancy outcome after 1st trimester exposure to statins - an evaluation based on the Embryotox cohort database

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00029177

Enrollment

840

Registered

2022-06-08

Start date

2022-03-01

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

Q89.9 O03 P95

Interventions

Group 1: Pregnancies with maternal 1st trimester statin therapy. Exposure time meets any time between conception (week 2+0 days) and week 12+6 days after last menstrual period (LMP). Therapy may have

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: For both cohorts: Enrollment of pregnancies, of which neither the outcome nor pathological results of prenatal diagnostics are known at the first contact. First contact during the study period 01.01.2000- 30.06.2021. Information on the outcome of pregnancy is completed. The quality of the information/data must comply with internal standards.

Exclusion criteria

Exclusion criteria: Malignancies; Cases with maternal exposure to considered potent teratogens or fetotoxicants: i.e. valproate, topiramate and carbamazepine as well as acenocoumarol, ACE-inhibitors and AT1- antagonists (exposure in 2nd and 3rd trimester), lenalidomide, methotrexate, mycophenolate, phenobarbital, phenprocoumon, phenytoin, retinoids (acitretin, adapalen, isotretinoin, tazaroten, tretinoin), thalidomide and warfarin. Missing data on pregnancy outcome.

Design outcomes

Primary

Measure	Time frame
To analyse the risk of major congenital birth defects and spontaneous abortions after 1st trimester exposure to statins.	—

Secondary

Measure	Time frame
To estimate the risk of low birth weight, gestational age at delivery (preterm birth) and pregnancy complications (i.e. preeclampsia, gestational diabetes). All outcomes are assessed with a questionnaire eight weeks after the estimated date of birth	—

Countries

Germany

Contacts

Public ContactAndrea Adelsberger,

Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum,

sekretariat-embryotox@charite.deTel +49 30 450 525 702,

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026