European Journal of Clinical Pharmacology

, Volume 68, Issue 5, pp 455–458

Clinical trials during pregnancy: what has been done

  • Viviana Domínguez
  • Nuria Ramos
  • Abiguei Torrents
  • David García
  • Xavier Carné
Review Article

DOI: 10.1007/s00228-011-1145-x

Cite this article as:
Domínguez, V., Ramos, N., Torrents, A. et al. Eur J Clin Pharmacol (2012) 68: 455. doi:10.1007/s00228-011-1145-x

Abstract

Objective

We describe clinical trials conducted in pregnant women.

Methods

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”.

Results

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.

Conclusion

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.

Keywords

Vulnerable populationPregnancyClinical trialsLabor inductionAbortion

Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Viviana Domínguez
    • 1
  • Nuria Ramos
    • 1
  • Abiguei Torrents
    • 2
  • David García
    • 1
  • Xavier Carné
    • 1
  1. 1.Department of Clinical Pharmacology, UASPHospital Clinic BarcelonaBarcelonaSpain
  2. 2.Statistics and Methodology Support Unit. IDIBAPSHospital Clinic BarcelonaBarcelonaSpain