Evaluation of fetotoxicity after 2nd and 3rd trimester exposure to NSAID, metamizole, acetylsalicylic acid and paracetamol
- Conditions
- MedDRA - 10049996 Ductus arteriosus premature closure MedDRA - 10013808 Ductus arteriosus stenosis foetalMedDRA - 10034130 Patent ductus arteriosus (PT, 21.1)MedDRA - 10030289 OligohydramniosMedDRA - 10066470 Amniorrhoea MedDRA - 10042062 StillbirthMedDRA - 10055690 Fetal deathMedDRA - 10050701 Congenital pulmonary hypertensionMedDRA - 10038447 Renal failure neonatalMedDRA - 10049778 Neonatal anuria MedDRA - 10030302 Oliguria
- Registration Number
- DRKS00015617
- Lead Sponsor
- Pharmakovigilanzzentrum Embryonaltoxikologie, Charité Universitätsmedizin Berlin
- Brief Summary
see abstracts: https://pubmed.ncbi.nlm.nih.gov/31310697/ https://pubmed.ncbi.nlm.nih.gov/36028798/
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 4000
Inclusion Criteria
These criteria apply for the exposed and comparison cohorts:
Prospective case reports ascertained and archived in the database of the German Embryotox Pharmacovigilance Centre. Prospectively ascertainment means that neither pregnancy outcome was known nor prenatal pathology had been diagnosed at the time our institute was contacted. Follow-up of pregnancy outcome including relevant data on the infant.
Data analysis will be based on documented cases exposed to the study medication archived in the database of the Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy (2008-2017).
Exclusion Criteria
Retrospective case reports
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the risk of fetotoxic effects after exposure to the study medication 1) Paracetamol during 3rd trimester, and 2) NSAIDs during 2nd and/or 3rd trimester, the following pre- and postnatal primary study endpoints will be investigated: intrauterine narrowing or closure of ductus arteriosus Botalli, patent fetal ductus arteriosus Botalli in the newborn, primary pulmonary hypertension in the newborn, other adverse pregnancy outcomes possibly such as late fetal death and stillbirth. <br>Initial collection of data during pregnancy are recorded by a structured questionnaire. Approximately eight weeks after the estimated date of birth another questionnaire is send to collect data about the pregnancy outcome.<br><br>
- Secondary Outcome Measures
Name Time Method Optional, explorative:<br>oligohydramnios and/or impaired renal function and prematurity/fetal distress<br>