From evidence to clinical practice; pregnancy specific dosing

Pregnant individuals are frequently treated with medicines, yet most drugs are not specifically studied. Therefore, doses are often not   adjusted for pregnancy.  Project Madam aims to fill this gap by developing pregnant-specific dose recommendations.

We focus on medicines that are commonly used in maternal care. Selection is based on clinical relevance, existing dosing guidance, labelling status, and the availability of clinical data in pregnancy.

For each selected drug, we develop a Dose Rationale Document (DRD). This document summarizes the best available scientific evidence on effectiveness, safety, and pharmacokinetics during pregnancy. A structured literature search ensures that all relevant data is included. Because high-quality clinical studies in pregnant individuals are often limited, we may complement clinical data with physiologically based pharmacokinetic (PBPK) modelling. When used, models are carefully validated before being incorporated into the DRD.

Draft dosing recommendations and the supporting evidence are reviewed by the multidisciplinary working committee including, clinicians, researchers, bioethicists, and patient representatives. The review process weighs the benefits and risks of the proposed dose, strength of evidence, feasibility, and safety monitoring strategies.

After approval, dosing recommendations are published openly and transparently. Antenatal dosing recommendations are published on Lareb – Moeders van Morgen, with full DRDs accessible here.