Performance of the Frameless IUD (Flexigard prototype inserter) and the TCu380A after six years as part of a WHO multicenter randomized comparative clinical trial in parous women

The clinical performance of the new Frameless IUD was compared with the TCu 380A, the most widely used copper IUD in the world today. Insertions of the Frameless IUD were conducted with a prototype inserter (Flexigard). We rep ort on the 6-year results from a randomized comparative clinical trial cond ucted at the Shanghai Institute of Planned Parenthood Research, as part of an international multicenter WHO clinical trial, involving 200 women, respe ctively recruited for use of each device. The cumulative 6-year pregnancy r ates were 0.0 per 100 women for the Frameless IUD and 3.3 for TCu380A. Term ination due to partial expulsion was significantly less for the Frameless I UD as compared with TCu380A (0.0 and 4.3 per hundred women, respectively). Complete expulsion, bleeding, pain, bleeding and pain and other medical rea sons for termination did not differ significantly between the two devices. The net cumulative continuation rates at six years per 100 women were 80.8 for TCu380A, and 83.0 for the Frameless IUD. Both Frameless IUD and TCu380A are highly effective, safe and acceptable co ntraceptive devices, because of low pregnancy rates (per 100 women), and lo w termination rates due to expulsion, pain, bleeding, and bleeding and pain . Due to its anchoring, the Frameless IUD is significantly more effective t han the TCu380A IUD as regards proper retention of the IUD in the uterine c avity. This may also explain its lower failure rate.