Abstract
An international multicentered clinical trial was designed to determine the possible role of intrauterine device (IUD) marker strings in the etiology of pelvic inflammatory disease (PID). A total of 1265 women were admitted and randomly allocated to receive either a standard TCu200 IUD or a TCu200 IUD without marker strings. These patients were followed-up through 12 months postinsertion. No statistically significant differences were found between the two groups of IUD users with respect to the incidence of PID or other types of infection or inflammation. The 12-month life table termination rates and overall continuation rates were also similar for users of the respective devices, with the exception of removal rates for bleeding/pain, which were significantly higher in the strings group than in the stringless group. However, the number of bleeding/pain complaints ever reported during the study were not statistically different in the two study groups. The study results indicate that the IUD string does not play an important role in the etiology of PID associated with the use of IUDs.
Resumé
Un essai clinique international a été mené dans plusieurs centres afin de déterminer le rôle possible des filaments conducteurs des dispositifs intra-utérins dans l'étiologie des maladies pelviennes inflammatoires (MPI). On a retenu un nombre total de 1265 femmes, auxquelles on a distribué par randomisation soit le DIU normal TCu200, soit le DIU TCu200 sans filament. Ces patientes ont été suivies pendant 12 mois après l'insertion. Statistiquement, aucune différence significative n'a été retrouvée entre les deux groupes d'utilisatrices de DIU pour ce qui est de l'incidence de MPI, ou autres types d'infection ou inflammation. On a constaté en outre, sur les tables de survie à 12 mois, que les taux de retrait et l'ensemble des taux de poursuite étaient similaires pour les deux dispositifs utilisés, exception faite du pourcentage de retrait pour cause de douleurs et saignements, qui était significativement plus élevé dans le groupe portant le dispositif à filament que dans l'autre. On n'a cependant pas noté de différence significative entre les groupes quant au nombre des femmes ayant signalé des saignements/douleurs pendant l'étude. Les résultats indiquent que le DIU à filament ne joue pas de rôle important dans l'étiologie des MPI associées à l'usage de ces dispositifs.
Resumen
Un ensayo clínico internacional se realizó en varios centros con el objeto de determinar la posible función de los filamentos conductores de los dispositivos intrauterinos en la etiología de las enfermedades pélvicas inflamatorias (EPI). Las 1265 mujeres participantes recibieron al azar ya sea el DIU normal TCu200, o el DIU TCu200 sin filamento. Se hizo el seguimiento de estas pacientes durante los 12 meses posteriores a la inserción. No se observaron diferencias estadísticamente significativas entre los dos grupos de usuarias de DIU con respecto a la incidencia de EPI u otros tipos de infección o inflamación. Además, se verificó en las tablas de supervivencia a los 12 meses que las proporciones de abandono y las proporciones generales de continuación eran similares en los dos grupos de usuarias, con excepción del porcentaje de abandono a causa de dolores y pérdidas de sangre, que fue significativamente mayor en el grupo que tenía el dispositivo con filamento que en el otro. Sin embargo, no se observó ninguna diferencia significativa entre los grupos respecto del número de mujeres que padecieron pérdidas de sangre/dolores durante el estudio. Los resultados indican que el DIU con filamento no desepeña un papel importante en la etiología de las EPI asociadas con el empleo de estos dispositivos.
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Supported in part by Family Health International, with funds from the United States Agency for International Development (USAID), although the views expressed do not necessarily reflect USAID policy.
This paper is based on a presentation given at the Seventh International Meeting of the Scoiety for the Advancement of Contraception, which was held in Singapore on 4–11 November, 1990.
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Potts, D.M., Champion, C.B., Kozuh-Novak, M. et al. IUDs and PID: a comparative trial of strings versus stringless devices. Adv Contracept 7, 231–240 (1991). https://doi.org/10.1007/BF01849413
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DOI: https://doi.org/10.1007/BF01849413