Skip to main content
MedPathMedPath Home
Clinical Trials/DRKS00015617
DRKS00015617
Completed
Not Applicable

Evaluation of fetotoxicity after 2nd and 3rd trimester exposure to NSAID, metamizole, acetylsalicylic acid and paracetamol - Fetotoxicity of NSAID

Pharmakovigilanzzentrum Embryonaltoxikologie, Charité Universitätsmedizin Berlin0 sites4,000 target enrollmentNovember 2, 2018
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsMedDRA - 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

Overview

Phase
Not Applicable
Intervention
Not specified
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
Sponsor
Pharmakovigilanzzentrum Embryonaltoxikologie, Charité Universitätsmedizin Berlin
Enrollment
4000
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

see abstracts: https://pubmed.ncbi.nlm.nih.gov/31310697/ https://pubmed.ncbi.nlm.nih.gov/36028798/

Registry
who.int
Start Date
November 2, 2018
End Date
December 31, 2019
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Pharmakovigilanzzentrum Embryonaltoxikologie, Charité Universitätsmedizin Berlin

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Similar Trials

Not yet recruiting
Not Applicable
Examination of Pregnant Women in Third Trimester by Ultrasound to Detect Any Congenital AnomaliesCongenital Anomaly
NCT06628063Sohag University40
Completed
Not Applicable
Third Trimester Modified Biophysical Profile Scan for Predicting Fetal Outcome.Perinatal DeathThird Trimester Modified Biophysical Profile Scan
NCT03729089Dr Andrew Odur198
Not yet recruiting
Not Applicable
Fetomaternal outcome in 3rd trimester obstetrics emergencies in a tertiary care centreHealth Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium
CTRI/2024/01/061713Department of obstetric and gynaecology
Completed
Not Applicable
Assessment of Third Trimester Post-void Residual and Validation of Bladder Scanner in Pregnancy and Post-partumPregnancy
NCT00782730West Virginia University35
Recruiting
Not Applicable
Premature infants and maternal pertussis immunization. Is second trimester vaccination beneficial?maternal vaccinationpertussisprematurepreterm infants
NL-OMON21026RIVM, UMC6,750