Teratology in the Twentieth Century Plus Ten by Harold Kalter

Author:Harold Kalter
Language: eng
Format: epub
Publisher: Springer Netherlands, Dordrecht

Randomized Trials

A study of the sort that was recommended to avoid various inadequacies had in fact already been conducted (Laurence et al. 1981). Women in two districts of south Wales who had previously given birth to children with NTD and were planning to have further children took part in a double-blind randomized control trial, one group taking 2 mg folic acid twice a day and the other a placebo. The outcome was positive, the first group having no NTD child in 44 pregnancies, and the second four in 51 pregnancies. But because an appreciable number of the folate group did not comply with the protocol and the overall number of women was relatively small the results were inconclusive. The outcome was also weakened perhaps by inclusion of non-neural tube central nervous system malformations.

It is unclear whether the same weakness was also true of a study conducted in Havana, one that had the advantage however of avoiding the imponderabilities of multivitamin ingestion, by patients taking only 5 mg folic acid daily (Vergel et al. 1990). Details of patient ascertainment, treatment compliance, etc. were not described; only that women registered in the Provincial Genetic Department as previously having had a pregnancy complicated by a NTD were included in the study. Again the unsupplemented women had a higher NTD recurrence rate than the supplemented ones, but the limited number prevented the difference from being significant.

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