Performance of the Frameless IUD (Flexigard prototype inserter) and the TCu380A after six years as part of aWHO multicenter randomized comparative clinical trial in parous women
- نوع فایل : کتاب
- زبان : انگلیسی
- مؤلف : LI HUI-QIN (1), FENG ZHUAN-CHONG (1),WANG YU-BAO (1), HAN YIAO-LIN (1), H. VAN KETS (2) and D.WILDEMEERSCH (3)
- چاپ و سال / کشور: 2000
Description
The clinical performance of the new Frameless IUD was compared with the TCu380A, the most widely used copper IUD in the world today. Insertions of the Frameless IUD were conducted with a prototype inserter (Flexigard). We report on the 6-year results from a randomized comparative clinical trial conducted at the Shanghai Institute of Planned Parenthood Research, as part of an international multicenter WHO clinical trial, involving 200 women, respectively recruited for use of each device. The cumulative 6-year pregnancy rates were 0.0 per 100 women for the Frameless IUD and 3.3 for TCu380A. Termination due to partial expulsion was signi¢cantly less for the Frameless IUD as compared with TCu380A (0.0 and 4.3 per hundred women, respec- tively). Complete expulsion, bleeding, pain, bleeding and pain and other medical reasons for termination did not di،er signi¢cantly 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 e،ective, safe and acceptable contraceptive devices, because of low pregnancy rates (per 100 women), and low termination rates due to expulsion, pain, bleeding, and bleeding and pain. Due to its anchoring, the Frameless IUD is signi¢cantly more e،ective than the TCu380A IUD as regards proper retention of the IUD in the uterine cavity. This may also explain its lower failure rate.
Advances in Contraception, 1999; 15: 201^209. #2000Kluwer Academic Publishers. Printed in theNetherlands
