Publication:
The Frameless Copper IUD (GyneFix) and the TCu380A IUD : Results of an 8-year Multicenter Randomized Comparative Trial

dc.contributor.authorMeirik, O.
dc.contributor.authorRowe, P. J.
dc.contributor.authorPeregoudov, A.
dc.contributor.authorPiaggio, G.
dc.contributor.authorPetzold, M.
dc.date.accessioned2012-03-30T07:31:19Z
dc.date.available2012-03-30T07:31:19Z
dc.date.issued2009
dc.description.abstractBACKGROUND: 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.citationContraception
dc.identifier.issn1879-0518 (Electronic) 0010-7824 (Linking)
dc.identifier.urihttps://hdl.handle.net/10986/5108
dc.language.isoEN
dc.relation.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/igo
dc.rights.holderWorld Bank
dc.subjectAdolescent
dc.subjectAdult
dc.subjectEquipment Design
dc.subjectFemale
dc.subjectFollow-Up Studies
dc.subjectHumans
dc.subjectCopper Intrauterine Devices
dc.subjectMetrorrhagia
dc.subjectPelvic Inflammatory Disease
dc.subjectPregnancy
dc.subjectEctopic Pregnancy
dc.subjectUnwanted Pregnancy
dc.subjectYoung Adult
dc.titleThe Frameless Copper IUD (GyneFix) and the TCu380A IUD : Results of an 8-year Multicenter Randomized Comparative Trialen
dc.title.alternativeContraceptionen
dc.typeJournal Articleen
dc.typeArticle de journalfr
dc.typeArtículo de revistaes
dspace.entity.typePublication
okr.doctypeJournal Article
okr.externalcontentExternal Content
okr.identifier.doi10.1016/j.contraception.2009.02.006
okr.identifier.externaldocumentum1810
okr.identifier.internaldocumentum19631788
okr.journal.nbpages133-41
okr.language.supporteden
okr.peerreviewAcademic Peer Review
okr.relation.associatedurlhttp://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=19631788
okr.volume80
Files