Background. The maternal and fetal risk of pregnancy after organ trans
plantation under tacrolimus has not been reported, This was prospectiv
ely studied in 27 pregnancies by 21 female liver recipients who were t
reated with tacrolimus before and throughout gestation. Method. Twenty
-seven babies were born between October 1990 and April 1996. In 15 cas
es, samples were obtained at or after delivery and stored (-40 degrees
C) for comparison of tacrolimus concentration in the maternal blood w
ith different combinations of cord and infant venous blood, breast mil
k, or a section of the placenta. Results. The 21 mothers had surprisin
gly few serious complications of pregnancy and no mortality, Two infan
ts with 23 and 24 weeks gestation died shortly after birth. The mean b
irth weight of the other 25 was 2638 +/- 781 g after a gestational per
iod of 36.6 +/- 3.3 weeks, Mean birth weight percentile for gestationa
l age was 50.2 +/- 26.2 (median 40). On the day of delivery, the mean
tacrolimus concentrations (ng/ml) were 4.3 in placenta versus 1.5, 0.7
, and 0.5 in maternal, cord, and child plasma, and 0.6 in the first br
east milk specimens. The infants had a 36% incidence of transient peri
natal hyperkalemia (K+ > 7.0 meq/L) and a mild reversible renal impair
ment, which were thought to reflect in part maternal homeostasis. One
newborn had unilateral polycystic renal disease (the only anomaly), Al
l 25 babies have had satisfactory postnatal growth and development wit
h a current mean weight percentile of 62 +/- 37 (median 80). Conclusio
ns. Pregnancy by postliver transplant mothers under tacrolimus was pos
sible with a surprisingly low incidence of the hypertension, preeclamp
sia, and other maternal complications historically associated with suc
h gestations. As in previous experience with other immunosuppressive r
egimens, preterm deliveries were common. However, prenatal growth for
gestational age and postnatal infant growth for postpartum age were no
rmal.