Prospective assessment of pregnancy outcome: RESULTS(2)

There was no statistical difference in the rates of major birth defects between the two groups. In the BDZ-exposed group, there was a single case of epiblepharon; in the control group, there were two cardiac anomalies, one ventricular septal defect, one atrial septal defect with pulmonary valve stenosis and an additional case of imperforate anus (Table 4). There was no statistical difference in the number of live births, elective abortions or reported miscarriages. Analysis of maternal characteristics is displayed in Table 5. Women exposed to BDZ tended to be significantly older and to have been pregnant more times than controls. The two groups were similar in other characteristics (Table 5). buy asthma inhalers

TABLE 4 Pregnancy outcome in benzodiazepine (BDZ)-exposed and control patients

BDZ-exposed(n=137) Nonteratogen-exposed (n=137) P
Pregnancy outcome Live birth 106/137 (77.4%) 115/137 (83.9%) 0.2
Miscarriage 19/137 (13.9%) 10/137 (7.3%) 0.1
Elective abortion 12/137 (8.8%) 12/127 (8.8%)
Major congenital defects* 1/106 (1%)f 3/115 (2.6%)t 0.69

*The defect in the BDZ-exposed group was epiblepharon, and the defects in the nonteratogen-exposed group were ventricular septal defect, atrial septal defect and pulmonary valve stenosis, and imperforate anus. finformation not available for five cases; tinformation not available for two cases

TABLE 5 Characteristics of benzodiazepine (BDZ)-exposed and nonteratogen-exposed women

BDZ-exposed(n=137) Nonteratogen-exposed (n=137) P
Maternal age 32.4±5(31.5-33.2) 30.4±5.1 (29.5-31.2) 0.002
Obstetrical history
Gravidity 2.4±1.5(2.1-2.6) 1.9±1.1 (1.7-2.1) 0.01
Parity 0.8±1 (0.6-1) 0.6±0.8(0.5-0.8) 0.07
Previous elective abortion 0.4±0.6(0.3-0.5) 0.2±0.6(0.1-0.4) 0.09
Previousmiscarriage 0.2±0.7(0.1-0.4) 0.2±0.4(0.1-0.3) 0.7
Abstainers 89/132 (66.9%) 96/125 (76.8%) 0.1*
# cigarettes smoked’1 17±11.1(13.6-19.9) 14.5±6.5(12.3-17.4) 0.3
Abstainers 55/124 (43.5%) 69/124 (55.6%) 0.08*
<1 drink/day 61/124 (49.2%) 48/124 (38.7%) 0.1
>1, <2 drinks/day 6/124 (4.8%) 5/124 (4%) 1
>2 drinks/day 3/124 (2.3%) 2/124 (1.6%) 1
Marital status
Single 9/104 (8.6%) 9/103 (8.7%) 0.8
Married 95/104 (91.3%) 94/103 (91.3%)

Continuous data are presented as mean ± SD (95% confidence interval). *Abstainers versus those who admitted ingesting; fBy those who admitted smoking

Of the live births of the controls, there were no intergroup differences in maternal weight gain, gestational age at delivery, birth weight, type of delivery (vaginal versus caesarean section) or neonatal complications (Table 6). Infants exposed in utero to BDZ attained their developmental milestones at ages similar to infants of the control group (Table 7).

TABLE 7 Age (in months) of attainment of developmental milestones for benzodiazepine-exposed and control infants

Benzodiazepine-exposed Nonteratogen-exposed P
First smiled 1.7±1 (n=81) 1.6±0.9 (n=98) 0.6
First lifted head 2.3±1.4 (n=67) 1.9±1.1 (n=87) 0.08
First sat unaided 5.8±1.5 (n=60) 5.6±1.2 (n=82) 0.5
First crawled 7.1 ±1.5 (n=58) 72±2.5 (n=76) 0.6
First stood 8.5±1.9 (n=53) 8.5±2.6 (n=71) 0.8
First word spoken 8.2±2.8 (n=42) 8.5±2.7 (n=62) 0.5
First walked unaided 11 ±2.2 (n=37) 11.3±2 (n=41) 0.5


Safra and Oakley reported that infants exposed in utero to BDZ had an increased risk of both cleft lip and palate. Other researchers, however, could not confirm this observation. Accepting only prospective data in the evaluation of rare outcomes may be falsely reassuring because it is often difficult to obtain a large enough sample size to detect a statistically significant elevation in the rate of that rare event. However, much of the discrepancy regarding BDZ use in pregnancy stems from physician-prompted concern regarding oral clefts in infants born to women who used BDZ during pregnancy. It is encouraging that we did not find a single case of cleft lip and/ or palate following corroboration of neonatal well-being by the infant’s physician in the 106 live born infants.