Abstract
Background
Clinical performance of the frameless copper IUD (GyneFix), designed to reduce side
effects related to the frame of conventional IUDs, and TCu380A was compared.
Study Design
Randomized Multicenter randomized comparative trial. Parous women requesting and eligible
to use IUD were admitted in 21 centers in eight countries in 1989���1993 and followed-up
for up to 8 years.
Results
Two thousand twenty-seven women were randomized to the frameless IUD and 2036 to TCu380A;
43 insertions of the frameless IUD failed and none for TCu380A. First-year expulsion
rate of the frameless IUD was 5.3 (95% CI: 4.4���6.4) per 100 and 2.5 (95% CI: 1.9���3.3)
for the TCu380A; second- through eighth-year expulsion rates were not different. First-year
pregnancy rates for the frameless IUD and TCu380A were 1.3 (95% CI: 0.9���2.0) and
0.5 (95% CI: 0.3���0.9), respectively; second- through eighth-year cumulative pregnancy
rates were 1.2 (95% CI: 0.7���1.9) and 2.5 (95% CI: 1.8���3.4), respectively. The
8-year cumulative rates of ectopic pregnancy and IUD removal for pain were lower for
the frameless IUD than for TCu380A. Removals for other reasons were not different.
Conclusions
The frameless IUD had more insertion failures, expulsions and pregnancies in the first
year than TCu380A, but fewer pregnancies from the second through the eighth year,
and by 8 years had fewer ectopic pregnancies and removals for pain.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to ContraceptionAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Mechanism of action, safety and efficacy of intrauterine devices. Report of a WHO Scientific Group. Technical Report Series 753.World Health Organization, Geneva1987
- The copper-fix IUD: a new concept in IUD technology.Adv Contracep. 1988; 4: 197-205
- The TCu380A IUD and the frameless IUD ���the FlexiGard���: interim three-year data from an international multicenter trial.Contraception. 1995; 52: 77-83
O'Brien PA, Marfleet C. Frameless versus classical intrauterine device for contraception. Cochrane Database of Systemic Reviews 2005, Issue 1. Art. No. CD003282. DOI: 10.102714651858.CD003282.pub.2 [Accessed 21 July 2008].
- The TCu 380A, TCu 220C, Multiload 250 and Nova T IUDs at 3, 5 and 7 years of use ��� Results from three randomized multicenter trials.Contraception. 1990; 42: 142-158
- Long-term reversible contraception: twelve years of experience with the TCu380A and TCu220C.Contraception. 1997; 56: 341-352
- Statistical tables for the design of clinical trials.Blackwell, Oxford1987
- Life-table methods for contraceptive research.Stat in Med. 1986; 5: 475-489
- Intrauterine devices and pelvic inflammatory disease: an international perspective.Lancet. 1992; 339: 785-788
- Dose- and age-dependent ectopic pregnancy risks with intrauterine contraception.Obstet Gynecol. 1991; 78: 291-298
- Expulsions following 1000 GyneFix insertions.J Fam Plann Reprod Health Care. 2001; 27: 135-138
- Performance of the frameless GyneFix and the TCu380A IUDs in a three-year multicenter randomized comparative trial in parous women.Contraception. 2000; 61: 91-98
- New frameless and framed intrauterine devices and systems ��� an overview.Contraception. 2007; 75: S82-S92
Article info
Publication history
Published online: April 01, 2009
Accepted:
February 5,
2009
Received in revised form:
February 5,
2009
Received:
November 18,
2008
Footnotes
���Conflict of interest of authors: Dr. Olav Meirik, Dr. Alexandre Peregoudov, Dr. Gilda Piaggio, Dr. Max Petzold: None. Dr. Patrick J Rowe: occasional consultancy services to Contrel Research.
������The views expressed in this article are those of the authors and do not necessarily represent the decisions or policies of the World Health Organization.
���Funding: UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.
Identification
Copyright
© 2009 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
