Publication: The Frameless Copper IUD (GyneFix) and the TCu380A IUD : Results of an 8-year Multicenter Randomized Comparative Trial
dc.contributor.author | Meirik, O. | |
dc.contributor.author | Rowe, P. J. | |
dc.contributor.author | Peregoudov, A. | |
dc.contributor.author | Piaggio, G. | |
dc.contributor.author | Petzold, M. | |
dc.date.accessioned | 2012-03-30T07:31:19Z | |
dc.date.available | 2012-03-30T07:31:19Z | |
dc.date.issued | 2009 | |
dc.description.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. | en |
dc.identifier.citation | Contraception | |
dc.identifier.issn | 1879-0518 (Electronic) 0010-7824 (Linking) | |
dc.identifier.uri | https://hdl.handle.net/10986/5108 | |
dc.language.iso | EN | |
dc.relation.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/igo | |
dc.rights.holder | World Bank | |
dc.subject | Adolescent | |
dc.subject | Adult | |
dc.subject | Equipment Design | |
dc.subject | Female | |
dc.subject | Follow-Up Studies | |
dc.subject | Humans | |
dc.subject | Copper Intrauterine Devices | |
dc.subject | Metrorrhagia | |
dc.subject | Pelvic Inflammatory Disease | |
dc.subject | Pregnancy | |
dc.subject | Ectopic Pregnancy | |
dc.subject | Unwanted Pregnancy | |
dc.subject | Young Adult | |
dc.title | The Frameless Copper IUD (GyneFix) and the TCu380A IUD : Results of an 8-year Multicenter Randomized Comparative Trial | en |
dc.title.alternative | Contraception | en |
dc.type | Journal Article | en |
dc.type | Article de journal | fr |
dc.type | ArtÃculo de revista | es |
dspace.entity.type | Publication | |
okr.doctype | Journal Article | |
okr.externalcontent | External Content | |
okr.identifier.doi | 10.1016/j.contraception.2009.02.006 | |
okr.identifier.externaldocumentum | 1810 | |
okr.identifier.internaldocumentum | 19631788 | |
okr.journal.nbpages | 133-41 | |
okr.language.supported | en | |
okr.peerreview | Academic Peer Review | |
okr.relation.associatedurl | http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=19631788 | |
okr.volume | 80 |