Congenital abnormalities in children of 43 pregnant women who attempted suicide with large doses of nitrazepam.

OBJECTIVE To evaluate the teratogenic effect of very large doses of nitrazepam in children born to pregnant women who attempted suicide and to check the feasibility of self-poisoning pregnant women model. DESIGN AND SETTING Comparative analysis of exposed children and their unexposed sibs born to the same mothers who attempted suicide during the study pregnancy and admitted to the toxicological inpatients clinic, Budapest, 1960-1993. STUDY PARTICIPANTS Of 1044 pregnant women who attempted suicide, 107 (10.3%) used large doses of nitrazepam alone or combination with other drugs, and 43 delivered live-born babies, these exposed children were evaluated. MAIN OUTCOMES MEASURES Structural birth defects, i.e., congenital abnormalities (CAs), pregnancy age at delivery, and birth weight. RESULTS The mean dose of nitrazepam used for suicide attempt was 204 mg. Of 43 exposed children, 13 (30.2%) were affected with CAs, while of their 29 sib controls, 3 (10.3%) (OR with 95%CI: 3.8, 1.0-14.6). Most CAs in exposed children were mild and belonged to the deformation type. The mean pregnancy age was shorter. CONCLUSIONS The very large doses of nitrazepam used for suicide attempt during pregnancy resulted in a high rate of CAs which may be connected with the disruption of protein metabolism in fetal mesenchyma. The self-poisoning pregnant women model is feasible for the evaluation of teratogenic effect of drugs.