Fetotoxicity of NSAIDS and RAAS-inhibitors in the 2nd and 3rd trimester of pregnancy (fetopathy approach)

Fetotoxicity of NSAIDS and RAAS-inhibitors in the 2nd and 3rd trimester of pregnancy (fetopathy approach) - NSAIDs and RAAS-inhibitors in the 2nd and 3rd trimester of pregnancy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011568

Enrollment

250

Registered

2017-03-31

Start date

2017-11-01

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 fetal MedDRA - 10050701 Congenital pulmonary hypertension O41.0 P01.2

Interventions

Group 1: Pregnant women with prenatally and/or neonatally confirmed study diagnoses (premature constriction or closure of ductus arteriosus, oligo- or anhydramnion) are examined and evaluated regardin

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Patients with during prenancy confirmed study diagnoses (oligohydramnios, narrowing or premature closure of the ductus arteriosus, pulmonary Hypertension) or the concomitant diseases of the newborn (neonatal or fetal right heart strain).

Exclusion criteria

Exclusion criteria: oligohydramnios with premature rupture of membranes

Design outcomes

Primary

Measure	Time frame
1. Can the hypothesis of an fetopathy (oligo- /anhydramnion or premature narrowing/closure of the ductus arteriosus after exposure to certain medications (NSAIDS, metamizole, RAAS-inhibitors) in the 2nd/3rd Trimester be confirmed and if so, can the risk for this be estimated? 2. When in the second half of pregnancy is the sensitive period for fetotoxicity related to the above mentioned medications? Information regarding this question is collected by means of a questionnaire during and after pregnancy.	—

Measure

Time frame

1. Can the hypothesis of an fetopathy (oligo- /anhydramnion or premature narrowing/closure of the ductus arteriosus after exposure to certain medications (NSAIDS, metamizole, RAAS-inhibitors) in the 2nd/3rd Trimester be confirmed and if so, can the risk for this be estimated? 2. When in the second half of pregnancy is the sensitive period for fetotoxicity related to the above mentioned medications? Information regarding this question is collected by means of a questionnaire during and after pregnancy.

—

Secondary

Measure	Time frame
1. Are there any signs of a minimum exposure time and/or a minimum dose before fetopathy develops? 2. Are there any other fetotoxic effects besides the known diagnostic findings of RAAS Inhibitor fetopathy? Information regarding this question is collected by means of a questionnaire during and after pregnancy.	—

Countries

Germany, Israel, Italy, Netherlands, Switzerland, United Kingdom

Contacts

Public ContactStefanie Hultzsch

Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin

stefanie.hultzsch at charite.de+49-30-3450525706

Outcome results

None listed

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