{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T07:01:12Z","timestamp":1772089272336,"version":"3.50.1"},"reference-count":22,"publisher":"BMJ","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Fam Plann Reprod Health Care"],"accepted":{"date-parts":[[2003,1,22]]},"published-print":{"date-parts":[[2003,4]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To assess insertion-linked pain and the short-term user-acceptability and safety of the GyneFix\u00ae as compared with T-framed intrauterine devices (IUDs).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Design<\/jats:title>\n                  <jats:p>A randomised controlled trial in an outpatient clinic setting.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Method<\/jats:title>\n                  <jats:p>Women requesting an IUD for emergency contraception (EC) were allocated to either the short-term arm (GyneFix\u00ae versus Nova-T200\u00ae, or the long-term arm (GyneFix versus Gyne-T380S\u00ae, and then randomised within each group. Visual analogue scores were used to assess the women's perception of the pain associated with insertion, which was patient-blinded. Follow-up was double-blinded, at 6 weeks, with bleeding and pain recorded over this time.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 175 women received an IUD in the long-term arm. The short-term arm was discontinued due to low recruitment (17 women at 20 months) and therefore the results relate to the long-term arm only. Outcome was known in 98% of subjects. The actual insertion procedure was scored as more painful for the GyneFix, both by the women (p = 0.013) and the doctors making their assessment of the women's pain (p = 0.04). The women with GyneFix described less pain in the subsequent 30 days after insertion (p = 0.005). Only 13% of women with GyneFix requested removal as compared with 20% with Gyne-T380S, with the difference being attributed to removal due to pain. The bleeding pattern was similar for those using GyneFix and Gyne-T380S.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Our study suggests that although the actual fitting may be more painful, pain is less during the 6 weeks after insertion of GyneFix and fewer women discontinue its use because of pain, as compared with Gyne-T380S. The high overall continuation rate of all emergency IUDs at 6 weeks and low morbidity seen in this study favours more frequent IUD insertion where unprotected intercourse has occurred, given also its higher efficacy over oral hormonal EC.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1783\/147118903101197485","type":"journal-article","created":{"date-parts":[[2005,3,5]],"date-time":"2005-03-05T01:30:57Z","timestamp":1109986257000},"page":"23-29","source":"Crossref","is-referenced-by-count":20,"title":["Randomised controlled trial assessing the acceptability of GyneFix\u00ae versus Gyne-T380S\u00ae for emergency contraception"],"prefix":"10.1136","volume":"29","author":[{"given":"Rachel E","family":"D'Souza","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tracey","family":"Masters","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Walli","family":"Bounds","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Guillebaud","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2003,4,1]]},"reference":[{"key":"ref_1","first-page":"24","article-title":"The postcoital copper-T. 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J Fam Plann Reprod Health Care 2001; 27: 139\u2013144.","journal-title":"J Fam Plann Reprod Health Care"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"135","DOI":"10.1080\/13625180008500386","article-title":"Randomised comparative trial in parous women of the frameless GyneFix\u00ae and the TCu380A intrauterine devices: long-term experience in a Chinese family planning clinic","volume":"5","author":"Cao, X.; Zhang, W.; Gao, G.","year":"2000","unstructured":"Cao X, Zhang W, Gao G, et al. Randomised comparative trial in parous women of the frameless GyneFix\u00ae and the TCu380A intrauterine devices: long-term experience in a Chinese family planning clinic. Eur J Contracept Reprod Health Care 2000; 5: 135\u2013140.","journal-title":"Eur J Contracept Reprod Health Care"},{"key":"ref_12","article-title":"Contraception today: a pocket book for general practitioners","author":"Guillebaud, J.","year":"2000","unstructured":"Guillebaud J. Contraception today: a pocket book for general practitioners (4th edn). London: Martin Dunitz, 2000.","edition":"4th edn"},{"key":"ref_13","article-title":"IUDs - an update. Population Reports (B6)","author":"Treiman, K.; Liskin, L.; Kols, A.","year":"1995","unstructured":"Treiman K, Liskin L, Kols A, et al. IUDs - an update. Population Reports (B6). Baltimore, MD: Johns Hopkins School of Public Health, Population Information Program, 1995."},{"key":"ref_14","first-page":"69","article-title":"Control of pain associated with intra-uterine device insertion using mefenamic acid","volume":"5","author":"Guillebaud, J.; Bounds, W.","year":"1983","unstructured":"Guillebaud J, Bounds W. Control of pain associated with intra-uterine device insertion using mefenamic acid. 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Performance of the frameless GyneFix\u00ae and the TCu380A IUDs in a 3-year multicentre, randomised, comparative trial in parous women. Contraception 2000; 61: 91\u201398.","journal-title":"Contraception"},{"key":"ref_19","article-title":"Efficacy of a mini version of the frameless GyneFix\u00ae intrauterine system (IUS) with effective copper surface area","author":"Wildemeersch, D.; Cao, X.; Zhang, W.","year":"2003","unstructured":"Wildemeersch D, Cao X, Zhang W, et al. Efficacy of a mini version of the frameless GyneFix\u00ae intrauterine system (IUS) with effective copper surface area of 200 mm2. Contraception 2003 (in press)."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"15","DOI":"10.3109\/13625189909043475","article-title":"GyneFix\u00ae-LNG: preliminary clinical experience with a copper and levonorgestrel releasing intrauterine system","volume":"4","author":"Wildemeersch, D.; Dhont, M.; Temmerman, M.","year":"1999","unstructured":"Wildemeersch D, Dhont M, Temmerman M, et al. GyneFix\u00ae-LNG: preliminary clinical experience with a copper and levonorgestrel releasing intrauterine system. Eur J Contracept Reprod Health Care 1999; 4:15\u201319.","journal-title":"Eur J Contracept Reprod Health Care"},{"issue":"2","key":"ref_21","first-page":"29","article-title":"Family Planning and","volume":"29","author":"of, Journal","year":"2003","unstructured":"Journal of Family Planning and Reproductive Health Care 2003; 29(2): 29\u201331","journal-title":"Reproductive Health Care"},{"key":"ref_22","article-title":"Introduction The GyneFix\u00ae is a flexible, frameless intrauterine device (IUD), developed in the mid-1980s, in an attempt to reduce the pain and bleeding associated with framed IUDs.1 It has been marketed in the UK since early 1998, and is currently licensed for 5-year use","unstructured":"Introduction The GyneFix\u00ae is a flexible, frameless intrauterine device (IUD), developed in the mid-1980s, in an attempt to reduce the pain and bleeding associated with framed IUDs.1 It has been marketed in the UK since early 1998, and is currently licensed for 5-year use."}],"container-title":["Journal of Family Planning and Reproductive Health Care"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1783\/147118903101197485","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,5]],"date-time":"2025-09-05T20:09:23Z","timestamp":1757102963000},"score":1,"resource":{"primary":{"URL":"https:\/\/jfprhc.bmj.com\/lookup\/doi\/10.1783\/147118903101197485"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2003,4]]},"references-count":22,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2003,4,1]]},"published-print":{"date-parts":[[2003,4]]}},"alternative-id":["10.1783\/147118903101197485"],"URL":"https:\/\/doi.org\/10.1783\/147118903101197485","relation":{},"ISSN":["1471-1893","2045-2098"],"issn-type":[{"value":"1471-1893","type":"print"},{"value":"2045-2098","type":"electronic"}],"subject":[],"published":{"date-parts":[[2003,4]]}}}