title: Clinical trials during pregnancy: what has been done.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Clinical Pharmacology, UASP, Hospital Clinic Barcelona, Villarroel 170, 08036 Barcelona, Spain. vidomingu@gmail.es
authors.forename: Viviana
authors.initials: V
authors.lastname: Domínguez
authors.forename: Nuria
authors.initials: N
authors.lastname: Ramos
authors.forename: Abiguei
authors.initials: A
authors.lastname: Torrents
authors.forename: David
authors.initials: D
authors.lastname: García
authors.forename: Xavier
authors.initials: X
authors.lastname: Carné
mesh_terms: D000019:Abortifacient Agents / Q000009:adverse effects; D000028:Abortion, Induced / Q000009:adverse effects / Q000379:methods; D002986:Clinical Trials as Topic / Q000009:adverse effects / Q000592:standards; D019587:Dietary Supplements / Q000009:adverse effects; D005260:Female; D005315:Fetal Diseases / Q000517:prevention & control* / Q000628:therapy; D006801:Humans; D007751:Labor, Induced / Q000009:adverse effects / Q000379:methods; D039382:Maternal Nutritional Physiological Phenomena; D010120:Oxytocics / Q000009:adverse effects; D017410:Practice Guidelines as Topic; D011247:Pregnancy; D011248:Pregnancy Complications / Q000517:prevention & control* / Q000628:therapy
chemical_list: D000019:Abortifacient Agents; D010120:Oxytocics
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