An evaluation of six new intrauterine devices.
A newer generation of IUDs that includes the Copper T-380A/Ag (TCu-380A/Ag) IUDs and the Multiload Copper-375 (MLCu375) IUDs has been developed and marketed. The high efficacy of these IUDs in preventing accidental pregnancies has been equated to that of oral contraceptives and even sterilization. However, the reduction of two other IUD-related pertinent events, namely, expulsion and medical removal due to bleeding and/or pain, has been less impressive. Therefore, efforts are continuing to develop new IUDs. In this paper, the authors review the physical structures of six new IUDs: the CU-SAFE, Cu-Fix, Ombrelle, Fincoid, and Multiload Mark II IUDs, and the intracervical fixing device (ICFD). The clinical performance of the first four devices is also evaluated. Independent, noncomparative studies suggest that all of the four new IUDs may perform as well as, or even better than, the TCu-380A IUD in terms of expulsions and medical removals attributable to bleeding and/or pain. However, we deem these results tentative, and emphasize the need for multi-center, randomized comparative clinical trials with larger sample sizes and long-term follow-up.
Clinical Trials Division, Family Health International, Research Triangle Park, NC 27709.
J
J
Boateng
I C
IC
Chi
D B
DB
Jones
D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D007433:Intrauterine Device Expulsion; D007434:Intrauterine Devices / Q000009:adverse effects; D007435:Intrauterine Devices, Copper / Q000009:adverse effects; D010146:Pain; D011247:Pregnancy; D014592:Uterine Hemorrhage / Q000209:etiology