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Clinical Trials/DRKS00029177
DRKS00029177
Enrolling By Invitation
Not Applicable

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

Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum,0 sites840 target enrollmentJune 8, 2022
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ConditionsQ89.9O03P95Congenital malformation, unspecifiedSpontaneous abortionFetal death of unspecified cause

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Q89.9
Sponsor
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum,
Enrollment
840
Status
Enrolling By Invitation
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 8, 2022
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

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

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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