Effects of NSAID and metamizole exposure in the 1st trimester of pregnancy - An observational cohort study series

• Conditions: Q89.9; O03; Congenital malformation, unspecified; Spontaneous abortion

• Registration Number: DRKS00011140
• Lead Sponsor: Pharmakovigilanzzentrum EmbryonaltoxikologieCharité-Universitätsmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-11
• Study Completion: 2017-10-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 7184

Inclusion Criteria

Prospectively ascertained pregnancies, i.e. neither the outcome of pregnancy nor results of prenatal diagnostics are primarily known, but are ascertained at a later stage

Exclusion Criteria

Exclusion of cases with maternal malignancies or maternal exposure considered as potent teratogens or fetotoxicants: i.e. acenocoumarol, ACE-inhibitors and ARBs (AT1-Antagonists), carbamazepine, lenalidomide, methotrexate, mycophenolate, phenobarbital, phenprocoumon, phenytoin, retinoids (acitretin, adapalen, isotretinoin, tazaroten, tretinoin), thalidomide, topimarat, valproic acid, warfarin.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Is there an increased rate of major birth defects after systemic exposure to the study medication [1) NSAIDs, 2) selective cox inhibitors (coxibes), 3) acetylsalicylic acid (ASA) in analgesic doses (defined as > 300mg/d), 4) metamizole] during 1. trimester of pregnancy?<br>Is there an increased rate of spontaneous abortion after systemic exposure to the study medication 1)-4) during 1. trimester of pregnancy?<br>The Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy counsels patients or their physicians about the risk of medication during pregnancy. This counselling mainly takes place in early pregnancy when outcome or prenatal diagnostic is not known. If the pregnant patient agrees, data are recorded by a structured questionnaire. Eight weeks after the estimated date of birth a further questionnaire is send to collect data about the pregnancy outcome.

Secondary Outcome Measures

Name	Time	Method
Is the risk for preterm delivery or low birthweight increased after systemic exposure to study medication 1)-4) during 1. trimester of pregnancy?<br>Is there evidence of an exposure time-dependence spontaneous abortion rate during the 1st trimester?