A randomized comparative clinical evaluation of the Steel Ring, the VCu200 and the TCu220c IUDs

Contraception. 1986 May;33(5):443-54. doi: 10.1016/s0010-7824(86)80003-8.

Abstract

A randomized comparative clinical study of the Steel Ring, VCu200 and TCu220c IUDs was carried out in Beijing. Six-hundred subjects were recruited and each group of 200 was inserted with one of the three devices. The TCu220c and the VCu200 had statistically significantly lower pregnancy and expulsion rates at one and two years of use than the Steel Ring. However, the Steel Ring consistently had the lowest rate of removal for pain and/or bleeding. At two years, the early differences of use-related discontinuation and continuation between the higher rates of the Steel Ring and the lower rates of the VCu200 and TCu220c were significantly reduced. There were no statistically significant differences of net event rates between VCu200 and TCu220c.

PIP: This comparative study evaluated the acceptability and effectiveness of 3 IUDs--the Steel Ring, the V-shaped Copper 200 (VCu200), and the T-shaped Copper 200c (TCu200c)--in parous Chinese women. 200 healthy women 20-39 years of age were randomly allocated to each of the 3 treatment groups. All subjects had had at least 1 full-term pregnancy. The TCu200c and VCu200 performed significantly better than the Steel Ring in terms of pregnancy and expulsion rates, at both the 1 and 2-year follow up; however, the latter device had significantly lower rates of removal for pain and bleeding. At 2 years, there had been 14 pregnancies in women using the Steel Ring, 6 in VCu200 users, and 2 in users of the TCu200c device; expulsions totalled 25, 3, and 7, respectively. Total use-related discontinuations at 2 years were 42, 28, and 34, respectively, among users of these 3 IUDs. Further evaluation will be conducted after 5 years of continuous use.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • China
  • Clinical Trials as Topic
  • Female
  • Humans
  • Intrauterine Device Expulsion
  • Intrauterine Devices* / adverse effects
  • Intrauterine Devices, Copper* / adverse effects
  • Pregnancy
  • Random Allocation