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  • Title: A prospective randomized comparative trial of the Gravigard, Latex Leaf, Dalkon Shield and Multiload Cu 250 IUDs.
    Author: McCarthy TG, Chew SC, Lim SM, Cheng MC, Ratnam SS.
    Journal: Aust N Z J Obstet Gynaecol; 1986 Aug; 26(3):228-32. PubMed ID: 3545173.
    Abstract:
    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. The effectiveness and complications of 4 IUDs--Gravigard, Latex Leaf, Dalkon Shield, and Multiload Cu 250--were compared in a prospective randomized clinical trial involving 843 acceptors. A total of 14,373 woman-months of IUD use were analyzed. At 24 months, the gross accidental pregnancy rate for the Dalkon Shield (10.4/100) was significantly higher than that for the Gravigard (4.3/100) and Multiload IUD (4.2/100); the pregnancy rate for the Latex Leaf device was 5.1/100. The Gravigard device had a significantly higher expulsion rate at 24 months (15.6/100) than the Dalkon Shield (2.1/100), Latex Leaf (5.2/100), or Multiload (3.7/100) devices. Use-related terminations were 38.1 for the Gravigard, 28.9 for the Dalkon Shield, 31.1 for the Latex Leaf, and 28.6 for the Multiload devices. Removal for pelvic inflammatory disease was necessary in 8 women (2 Latex Leaf acceptors,3 Dalkon Shield users, and 3 Gravigard acceptors). There was no case of septic abortion in this series. Although the Latex Leaf performed comparatively well in this study, it was found that over time the rubber degenerates and becomes separated from the thread when removal is attempted. In general, the Multiload Cu 250 appears to be one of the best currently available IUDs, because of its low pregnancy and expulsion rates.
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