Investigation of embryotoxic effects of maternal therapy with vitamin k antagonist phenprocoumon in pregnancy: the experience of the Embryotox- database

Investigation of embryotoxic effects of maternal therapy with vitamin k antagonist phenprocoumon in pregnancy: the experience of the Embryotox- database - Phenprocoumon in pregnancy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00007620

Enrollment

2100

Registered

2015-09-09

Start date

2015-03-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

MedDRA - 10051445 foetal warfarin syndrome coumarin embryopathy, congenital anomalies, spontaneous abortion after intrauterine exposition with phenprocoumon Q86.8

Interventions

Group 1: Prospectively (call in the early pregnacy without informations of outcome) ascertained pregnancies of the embryotox-database with maternal phenprocoumon therapy at least 32 days before concep

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Prospectively ascertained pregnancies. Study cohort Prospectively ascertained pregnancies with maternal phenprocoumon therapy. Exposure interval at least 32 days before conception (2 weeks + 4 days before the first day of the last menstrual period (LMP)) and week 12+6 days after LMP. Therapy may have started earlier and can have lasted longer. Control group Prospectively ascertained pregnancies without phenprocoumon or other coumarin- derivates (acenocoumarol, warfarin, coumadine) exposure during any time in pregnancy.

Exclusion criteria

Exclusion criteria: Exclusion criteria are women with acute malignancies, with tumors, with seizures (except preeclampsia) and cases with maternal exposure to the following drugs considered as major teratogens or fetotoxicants: carbamazepine, lenalidomide, methotrexate, mycophenolate, phenobarbital, phenytoin, retinoids (acitretin, adapalen, isotretinoin, tazaroten, tretinoin), thalidomide, topiramate, valproic acid, angiotensin-converting enzyme (ACE)-inhibitors and angiotensin II receptor antagonists.

Design outcomes

Primary

Measure	Time frame
Eight weeks after estimated date of birth we send a follow-up questionnaire. Primary outcomes are delivery of a child with/ without major birth defects , spontaneous abortion, stillbirth, elective termination of pregnancy.	—

Secondary

Measure	Time frame
pretermbirth,risk of low birth weight, pregnancy complications (e.g. preeclampsia), severe maternal drug-specific side effects (e.g. bleeding complications), fetotoxic effects	—

Countries

Germany

Contacts

Public ContactEleanor Hüttel

Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie; Charité Universitätsmedizin

eleanor.huettel@charite.de0049- 30 - 450525700

Outcome results

None listed

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