[Follow-up of children in obstetrical clinical trials: research experience in Italy].
The effectiveness of treatments for the mother exposed to adverse events in pregnancy is not always interpreted in the light of possible effects on the child. The follow-up of infants is an important component of obstetric and perinatal audit not only in randomised clinical trials but as part of routine health care. The results of the 18 month's follow-up of children born from women recruited in the Italian Study of Aspirin in Pregnancy and in the Italian Trial on Nifedipine in Pregnancy are discussed. No significant differences emerged between treatment and no-treatment groups with respect to indicators of development and health status. Malformations, diseases, and other health problems showed no specific patterns and were much the same in the groups. Our findings suggest that the use of low-dose aspirin and calcium channel blocker nifedipine in pregnancy is safe with respect to the risks of malformation and of major impairment in development at 18 months of age.
Bortolus
R
R
Istituto di Ricerche Farmacologiche Mario Negri di Milano, Italia.
Parazzini
F
F
Zanardo
V
V
D001241:Aspirin / Q000627:therapeutic use*; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D007558:Italy; D009543:Nifedipine / Q000627:therapeutic use*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011297:Prenatal Exposure Delayed Effects; D016032:Randomized Controlled Trials as Topic
D002121:Calcium Channel Blockers; D009543:Nifedipine; D001241:Aspirin