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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00015617

Enrollment

4200

Registered

2018-11-02

Start date

2008-01-01

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 - 10049996 Ductus arteriosus premature closure MedDRA - 10013808 Ductus arteriosus stenosis foetal MedDRA - 10034130 Patent ductus arteriosus (PT, 21.1) MedDRA - 10030289 Oligohydramnios MedDRA - 10066470 Amniorrhoea MedDRA - 10042062 Stillbirth MedDRA - 10055690 Fetal death MedDRA - 10050701 Congenital pulmonary hypertension MedDRA - 10038447 Renal failure neonatal MedDRA - 10049778 Neonatal anuria MedDRA - 10030302 Oliguria

Interventions

Group 1: Patients exposed to paracetamol in the 3rd trimester. Treatment may have started before or during the 3rd trimester. Cases are not allowed to be exposed to NSAIDs (non-steroidal anti-inflamma

Eligibility

Sex/Gender

Female

Inclusion 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

Exclusion criteria: Retrospective case reports

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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.

—

Secondary

Measure	Time frame
Optional, explorative: oligohydramnios and/or impaired renal function and prematurity/fetal distress	—

Countries

Germany

Contacts

Public ContactKatarina Dathe

Pharmakovigilanzzentrum Embryonaltoxikologie Charité Universitätsmedizin Berlin

katarina.dathe@charite.de004930450525743

Outcome results

None listed

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