Showing papers by "Ronald T. Burkman published in 1996"

Intrauterine devices and pelvic inflammatory disease: evolving perspectives on the data.

Abstract: In order to present an overview of current understanding about the relationship between pelvic inflammatory disease (PID) and IUD use this paper reviews the evolution of pertinent studies and identifies study design limitations. The first section includes a tabulated outline of the initial epidemiological studies that indicated an association between PID and IUD use (1968-80) and describes the biases in these studies. Section 2 considers the contribution of the US Womens Health Study the largest case-control study of the relationship which addressed many of these concerns and indicated that the risk of IUD-associated PID was primarily related to insertion that the Dalkon shield increased risk and that monogamy reduced risk. A table illustrates relative risk found by this study for various scenarios. Next the two analyses of data (1981 and 1990) from the Oxford Family Planning Association Study are reviewed and risk data from both publications are tabulated. Section 4 looks at the World Health Organizations 1992 study that used data collected in 12 randomized and one nonrandomized clinical trial from centers throughout the world. Data are tabulated to show rate of PID for various types of IUDs and two durations of use. This study confirmed that greatest risk is associated with insertion. The paper then provides an analysis of each of the following current conclusions regarding PID risk and IUD usage: 1) risk is primarily confined to time of insertion (except for the Dalkon shield); 2) in women with no risk factors the IUD poses little risk of tubal infection; 3) screening for IUD use may reduce absolute risk; 4) copper IUDs (especially the copper T380A) pose lower risk; and 5) Actinomyces israelii is not thought to be a major pathogen in this clinical setting.

"Performance of the TCu380A and Cu-Fix IUDs in an International Randomized Trial".

Abstract: To compare the clinical performance of the TCu380A, the most widely used copper IUD in the world today, and a new frameless device, the Cu-Fix, we report results from a randomized international two-year clinical trial involving 874 parous women followed for an average of fourteen months. Event rates at the end of two years (per 100 women) for pregnancy were 0.0 for the TCu380A and 1.5 for the Cu-Fix. Termination due to expulsion was significantly less for TCu380A as compared with Cu-Fix users (2.0 and 11.4 per hundred women, respectively); other medical reasons for termination (bleeding/pain, pelvic inflammatory disease (PID), and other) did not differ significantly. PID incidence rates at two years were 1.0 per hundred women for the TCu380A and 1.6 for the Cu-Fix (equivalent to 6.0 and 8.3 per 1,000 woman-years, respectively). The net cumulative continuation rates at two years per hundred women were 78.8 for TCu380A, and 71.9 for the Cu-Fix. Both IUDs provide highly effective protection against pregnancy, but the TCu380A has a lower expulsion rate. The low rate of PID indicates that it is an in-frequent occurrence in appropriately selected candidates.