Il follow-up dei bambini nei trial clinici ostetrici: Esperienze di ricerca in Italia

Translated title of the contribution: Follow-up of children on obstetric clinical trials: Experiences of research in Italy

R. Bortolus, F. Parazzini, V. Zanardo

Research output: Contribution to journalArticle

Abstract

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.

Translated title of the contributionFollow-up of children on obstetric clinical trials: Experiences of research in Italy
Original languageItalian
Pages (from-to)243-248
Number of pages6
JournalPediatria Medica e Chirurgica
Volume21
Issue number6
Publication statusPublished - 1999

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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