Observational cohort study of pregnancy outcomes after intrauterine exposure to clindamycin based on the Embryotox cohort

Conditions: O03
P95
Q89.9
Congenital malformation, unspecified
Spontaneous abortion
Fetal death of unspecified cause

Registration Number: DRKS00032881

Lead Sponsor: Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 400

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 (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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimating the risk of<br>a) Major congenital birth defects after exposure to Clindamycin during 1st trimester<br>b) Spontaneous abortion/fetal death after exposure to Clindamycin during 1st trimester

Secondary Outcome Measures

Name	Time	Method
Estimating the risk of <br>a) Low birth weight (small for gestational age = SGA), low head circumference, prematurity after exposure to Clindamycin during pregnancy<br>b) Fetal death/stillbirths after exposure to Clindamycin during pregnancy (incl. the 2nd and 3rd trimester)