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Clinical Update: Frameless Versus
Classical IUD with Copper-bearing Frame
(March 2002)
O'Brien PA and C Marfleet. 2002. Frameless Versus Classical Intrauterine Device for Contraception (Cochrane Review). *The Cochrane Library*, Issue 1. Update Software: Oxford.
Introduction
O'Brien and Marfleet analyzed three studies to determine the performance of frameless IUDs compared to framed IUDs. The authors compared rates of expulsion, pregnancy, ectopic pregnancy, removal (for pain and/or bleeding, bleeding alone, pain alone, pelvic inflammatory disease) and perforation.
Methodology
Six studies were identified. Of these, data from three studies that fulfilled the study selection criteria were analyzed. In these three studies, more than 5,800 women were randomized to either a frameless IUD or the TCu380A. Women years of experience available for analysis were around 11,000 with the frameless IUD and 12,000 with the TCu380A. All three studies excluded nulliparous women.
Results
No statistically significant difference was found in pregnancy rate, removals for excessive pain and/or bleeding, removals for pain alone, continuation rate and pelvic inflammatory disease. In the first year, the expulsion rate was higher with the frameless device (RR 2.48, 95% CI 1.89 to 3.26). However, at the end of the third year the expulsion rate was lower with the frameless device (RR 0.41, 95% CI 0.19 to 0.87). At the end of six years, the removal rate for bleeding was higher with the frameless device than with the framed device. The overall rate of ectopic pregnancy was very low with both types of IUD. The proportion of pregnancies that were ectopic was lower with the frameless IUD. No perforations were reported with either type of IUD. In one of the trials, which used the new inserter, it was not possible to determine whether the reduced number of expulsions was attributable to the new inserter or to the providers' skills.
Conclusions
The authors concluded that data are insufficient to show that problems of early expulsions have been overcome with the new inserter. Apart from that, the frameless IUD performs similarly to the TCu380A and appears to have a lower pregnancy rate in later years, although the absolute difference is small.
Studies included in the review
- Rosenberg MJ et al. 1996. Performance of the TCu380A and Cu-Fix IUDs in an international randomized trial. *Contraception* 53(4): 197-203.
- Rowe PJ et al. 1995. The TCu 380A IUD and the frameless IUD 'the FlexiGard': Interim three-year data from an International Multicenter Trial. *Contraception* 52(2): 77-83.
- Wu S, J Hu and D Wildemeersch. 2000. Performance of the frameless GyneFix and the TCu380A IUDs in a 3-year multicenter, randomized, comparative trial in parous women. *Contraception* 61(2): 91-8.
This summary was contributed by Chandrakant Ruparelia, Clinical Training Advisor at JHPIEGO. Visit the Cochrane Library.