Q89.9 O03 P95
Conditions
Interventions
Group 1: Observational study: Documented pregnancies based on data of the Embryotox cohort (study period: 01.01.2000 until 31.07.2023)
Arm 1: Study cohort (Clindamycin-exposed): Approximately 450 preg
Sponsors
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: For study cohorts: Enrollment of pregnancies, of which neither the outcome nor pathological results of prenatal diagnostics are known at the first contact. First contact with the Embryotox Center of Clinical Teratology and Drug Safety in Pregnancy, Berlin during the study period 01.01.2000- 31.07.2023. Information on the outcome of pregnancy is completed. The quality of the information/data must comply with internal standards.
Exclusion criteria
Exclusion criteria: Exclusion criteria (applies for the exposed cohort and the control cohorts): -Malignant diseases -Exposure to proven teratogens [acenocoumarol, carbamazepine, lenalidomide, methotrexate, mycophenolate, phenobarbital, phenprocoumon, phenytoin, retinoids (acitretin, adapalene, alitretinoin, isotretinoin, tazarotene, tretinoin, trifarotene), topimarate, thalidomide, valproic acid, warfarin]; Exposure to fetotoxic substances in the second and/or third trimester [angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists] -Topical/cutaneous application of clindamycin (exception: vaginal application) -Indication for clindamycin treatment due to pathological pregnancy complications (e.g. preterm labour, premature rupture of membranes) caused by infection in late pregnancy -Insufficient data on pregnancy outcome or non-plausible, missing relevant data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimating the risk of a) Major congenital birth defects after exposure to Clindamycin during 1st trimester b) Spontaneous abortion/fetal death after exposure to Clindamycin during 1st trimester | — |
Secondary
| Measure | Time frame |
|---|---|
| Estimating the risk of a) Low birth weight (small for gestational age = SGA), low head circumference, prematurity after exposure to Clindamycin during pregnancy b) Fetal death/stillbirths after exposure to Clindamycin during pregnancy (incl. the 2nd and 3rd trimester) | — |
Countries
Germany
Contacts
Public ContactSimone Alt
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie
Outcome results
None listed