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Randomised controlled trial assessing the acceptability of GyneFix® versus Gyne-T380S® for emergency contraception
  1. Rachel E D'Souza, MRCOG, Specialist Registrar in Sexual and Reproductive Health1,
  2. Tracey Masters, MRCOG, MFFP, Clinical Manager Avon Brook2,
  3. Walli Bounds, SCM, Principal Research Fellow3 and
  4. John Guillebaud, FRCSEd, FRCOG, Medical Director and Professor of Family Planning and Reproductive Health4
  1. Margaret Pyke Centre, London, UK
  2. Bristol, UK
  3. Department of Obstetrics and Gynaecology, University College London and Research Co-ordinator, Margaret Pyke Centre*, London, UK
  4. Margaret Pyke Centre*, London, UK
  1. Correspondence Dr R E D'Souza, Margaret Pyke Centre, 73 Charlotte Street, London W1T 4PL, UK. Tel: +44 (0)20 7530 3631. E-mail: Rachel.D'Souza{at}camdenpct.nhs.uk

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).

Design A randomised controlled trial in an outpatient clinic setting.

Method 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.

  • Accepted January 22, 2003.

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  • Accepted January 22, 2003.

Footnotes

  • * Now retired.

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