A prospective, randomized clinical trial was conducted to study the sa
fety and efficacy of the Cytobrush for Papanicolaou smear screens in 2
52 pregnant women. Two groups-Ayre spatula plus Cytobrush and Ayre spa
tula plus cotton swab-were compared. There was a higher incidence of s
potting with each of the three devices as compared with studies of non
pregnant women. The highest incidence of spotting at time of exam occu
rred with the Cytobrush; however, this spotting was not clinically sig
nificant. Eleven first-trimester women experienced a pregnancy loss; f
ive of these losses were due to a hydatidiform mole or missed abortion
that occurred before the exam. Six women (2%) aborted spontaneously c
ompared with a 10% incidence reported in the literature. It was conclu
ded that all three devices are safe for use in pregnancy. In addition,
the most adequate screen for retrieval of squamous epithelial cells w
as found to be the Ayre spatula, while the Cytobrush proved most effec
tive for retrieval of endocervical epithelial cells.