Research Article

Double-blind randomised controlled trial of folate treatment before conception to prevent recurrence of neural-tube defects.

Br Med J (Clin Res Ed) 1981; 282 doi: https://doi.org/10.1136/bmj.282.6275.1509 (Published 09 May 1981) Cite this as: Br Med J (Clin Res Ed) 1981;282:1509
  1. K M Laurence,
  2. N James,
  3. M H Miller,
  4. G B Tennant,
  5. H Campbell

    Abstract

    A randomized controlled double-blind trial was undertaken in south Wales to prevent the recurrence of neural-tube defects in women who had had one child with a neural-tube defect. Sixty women were allocated before conception to take 4 mg of folic acid a day before and during early pregnancy and 44 complied with these instructions. Fifty-one women were allocated to placebo treatment. There were no recurrences among the compliant mothers but two among the non-compliers and four among the women in the placebo group. Thus there were no recurrences among those who received supplementation and six among those who did not; this difference is significant (p = 0.04). It is concluded that folic acid supplementation might be a cheap, safe, and effective method of primary prevention of neural-tube defects but that this must be confirmed in a large, multicentre trial.