Standard instructions for diaphragm use call for an individually sized
latex diaphragm, used in conjunction with spermicide jelly. However,
some investigators have reported that the diaphragm can be effective w
ithout a spermicide. A non-randomized trial designed to measure the co
ntraceptive effectiveness of the diaphragm used without spermicide was
conducted. A total of 110 self-selected women were enrolled to use a
non-spermicide fit-free (60mm) diaphragm for a period of one year. The
y were advised to wear the diaphragm continuously, removing it once ea
ch day for washing but not within six hours after intercourse. Product
-related problems related to insertion, retention and removal were few
at both the 6- and 12-month follow-up visits, most commonly odor. The
12-month Life table accidental pregnancy rate during typical use was
24.1 per 100 women (29.5 per 100 women without female barrier experien
ce and 17.9 per 100 women with barrier experience). Over 85% of the wo
men who returned for follow-up visits reported using the diaphragm dur
ing every act of intercourse. Until better data refute the traditional
recommendations, users should be advised to add spermicide to fitted
latex diaphragms.