title: Randomised controlled trial assessing the acceptability of GyneFix versus Gyne-T380S for emergency contraception.
abstract: OBJECTIVE
  To assess insertion-linked pain and the short-term user-acceptability and safety of the GyneFix as compared with T-framed intrauterine devices (IUDs).
  
  
  METHODS
  A randomised controlled trial in an outpatient clinic setting.
  
  
  METHODS
  Women requesting an IUD for emergency contraception (EC) were allocated to either the short-term arm (GyneFix versus Nova-T200, or the long-term arm (GyneFix versus Gyne-T380S, 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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Margaret Pyke Centre, London, UK. D'Souza@camdenpct.nhs.uk
authors.forename: Rachel E
authors.initials: RE
authors.lastname: D'Souza
authors.forename: Tracey
authors.initials: T
authors.lastname: Masters
authors.forename: Walli
authors.initials: W
authors.lastname: Bounds
authors.forename: John
authors.initials: J
authors.lastname: Guillebaud
mesh_terms: D000293:Adolescent; D000328:Adult; D016503:Drug Delivery Systems; D004638:Emergency Treatment / Q000379:methods*; D005260:Female; D006801:Humans; D007435:Intrauterine Devices, Copper / Q000009:adverse effects / Q000145:classification; D008131:London; D010146:Pain / Q000453:epidemiology / Q000209:etiology; D010147:Pain Measurement; D010342:Patient Acceptance of Health Care; D011247:Pregnancy; D013222:State Medicine; D014592:Uterine Hemorrhage / Q000453:epidemiology / Q000209:etiology