More than 700,000 pregnancies per year are managed in the UK alone. More women than ever require medication therapy during regnancy or labour as they are having babies later in life and medical breakthroughs have made some pregnancies possible for the first time.
Clinical pharmacology in obstetrics is poorly understood. Pregnant women are actively excluded from late phase clinical trials (Phase 3) because of the safety concerns and ethical issues.
Pharmacokinetic and pharmacodynamic data are lacking, in particular longitudinal studies that address changes in distribution, metabolism and elimination of drugs in relation to gestational age.
The unwillingness of the pharmaceutical industry to consider obstetric indications for existing products led to considerable off-label prescribing similar to that seen in paediatric practice.
Drugs administered in pregnancy can have important short term impact in terms of teratogenicity and maternal side effects, but also potentially long term consequences (the Barker hypothesis) which are poorly understood.