Clinical trials during pregnancy: what has been done
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- Domínguez, V., Ramos, N., Torrents, A. et al. Eur J Clin Pharmacol (2012) 68: 455. doi:10.1007/s00228-011-1145-x
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We describe clinical trials conducted in pregnant women.
We searched PubMed database for articles related to clinical trials between 01/01/2000 and 31/12/2009 involving pregnant women by using the preferred terms “pregnancy”, “human”, and “clinical trials”.
Of 1,264 retrieved publications, 762 (60%) were excluded, leaving 502 for analysis: 53% were preventive studies in maternal or fetal conditions; 47% were therapeutic trials, mostly focused on acute obstetric diseases; 66% were assigned a pharmacological intervention. The studied drugs were 16% for labour induction and 15% for abortive procedures, followed by multivitamins and micronutrients, labour analgesia and anesthesia, antibiotics, tocolytics, and antimalarial drugs. The main objectives of the studies were focused on efficacy (54%) and efficacy and safety (26%); 81% of the studies were controlled, randomized and parallel-design trials; 19% were blinded.
Clinical trials in pregnant women are mainly conducted with an efficacy objective regarding maternal–fetal prevention and in obstetric diseases to study labor induction and abortive measures. This is in line with the type of intervention and drugs involved.