A prospective randomized comparative trial of the Gravigard, Latex Leaf, Dalkon Shield and Multiload Cu 250 IUDs.
This prospective randomized trial in 843 patients compared the effectiveness and complications of 4 intrauterine devices. At 24 months the gross accidental pregnancy rate for the Dalkon Shield was higher than for the 7Cu200 (p less than 0.05) and the ML Cu250 (p less than 0.05). The 7Cu200 had a higher expulsion rate than the Dalkon Shield (p less than 0.01), Latex Leaf (p less than 0.001) and ML Cu250 (p less than 0.001). Use-related terminations were higher for the 7Cu200 than for the ML Cu250 (p less than 0.01). Removal for pelvic inflammatory disease was necessary in 8 women (2 for the Latex Leaf and 3 each for the 7Cu200 and Dalkon Shield). There was no significant difference in termination rates between the ML Cu250 and Latex Leaf but subsequently the Leaf has given problems with removal particularly in women who have defaulted follow-up for several years.
D000328:Adult; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007434:Intrauterine Devices; D007435:Intrauterine Devices, Copper; D010352:Patient Dropouts; D011247:Pregnancy; D011446:Prospective Studies; D011897:Random Allocation