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Frameless versus classical intrauterine device for contraception.

P A O'Brien1, C Marfleet

  • 1Services for Women, Parkside Health, St Charles Hospital, Exmoor St, London, UK, W10 6DZ. paul.obrien@westminster-pct.nhs.uk

The Cochrane Database of Systematic Reviews
|January 28, 2005
PubMed
Summary

The frameless intrauterine device (IUD) shows similar performance to the framed TCu380 IUD, with a potentially lower pregnancy rate in later years. However, data is insufficient to confirm if early expulsion issues are resolved with the GyneFix device.

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Area of Science:

  • Gynecology
  • Reproductive Health
  • Medical Devices

Background:

  • The frameless intrauterine device (IUD) utilizes a nylon thread anchored in the uterine fundus for placement, differing from classical framed IUDs.
  • Copper sleeves are attached to the nylon thread for contraception.

Purpose of the Study:

  • To evaluate the frameless IUD GyneFix regarding expulsion and pregnancy risks.
  • To assess GyneFix's impact on bleeding and pain, common reasons for early IUD removal.

Main Methods:

  • A systematic review of randomized controlled trials comparing frameless (GyneFix) and framed (TCu380) IUDs for contraception.
  • Searches conducted in Cochrane Controlled Trial Register, MEDLINE, and Popline from 1980 to March 2004.
  • Data extraction and analysis included calculating rate ratios and differences, with heterogeneity testing.

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Main Results:

  • Four trials involving 5,939 women were analyzed, with up to eight years of follow-up.
  • Early trials using a prototype introducer showed higher expulsion rates.
  • The large WHO trial indicated a lower pregnancy risk with the frameless device between two and six years.
  • Removals for bleeding or pain did not significantly differ between frameless and framed IUDs.

Conclusions:

  • Insufficient data exists to confirm if the modified GyneFix introducer resolves early expulsion issues.
  • The frameless IUD demonstrates comparable performance to the TCu380, with a potentially small but significant reduction in pregnancy rates in later years.