Randomised controlled trial assessing the acceptability of GyneFix versus Gyne-T380S for emergency contraception.

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.

Comparative trial of the force required for, and pain of, removing GyneFix versus Gyne-T380S following randomised insertion.

OBJECTIVE: To assess the force required for, and pain of, removal of the GyneFix as compared with T-framed intrauterine devices (IUDs). DESIGN: A comparative trial following patient-blinded randomisation in an outpatient clinic setting. METHOD: Women requesting an IUD for emergency contraception were fitted with either a GyneFix or a Gyne-T380S. For those requesting removal of the IUD, visual analogue scores were used to assess their perception of the associated pain, and a Newton dynamometer was used to measure the force required to remove the device. RESULTS: Removal required significantly more force for GyneFix as compared with Gyne-T380S (p = 0.004), but there was no significant difference in pain perceived by women during removal. Interestingly, anticipated pain was worse than actual pain experienced. CONCLUSION: Although more force is needed to remove the GyneFix as compared with the Gyne-T380S, this does not translate into more pain.

Observational series on women using the contraceptive Mirena concurrently with anti-epileptic and other enzyme-inducing drugs.

CONTEXT: Contraception for women on enzyme-inducing drugs. OBJECTIVE: To gather preliminary information on the contraceptive efficacy of the hormone-releasing intrauterine system (IUS) Mirena, when used concurrently with enzyme-inducers. DESIGN: Observational series. SETTING/PARTICIPANTS: Mirena users on enzyme-inducers were recruited from within the Margaret Pyke Centre and via doctors from throughout the UK. Data were collected systematically on structured questionnaires with particular reference to duration of Mirena use, exposure to pregnancy risk, type of concurrent medication, and reasons for drop-out. MAIN OUTCOME MEASURE: Accidental pregnancies. RESULTS: To date, 56 women have provided follow-up information. Most took enzyme-inducers for epilepsy. They have accumulated 1454 months of use, of which 1075 months represent exposure to pregnancy risk. Only one apparently true Mirena failure has been documented, representing a failure rate of 1.1 per 100 woman-years (95% CI 0.03-6.25). Including a second pregnancy, probably conceived after the Mirena had been removed,would raise the failure rate to 2.2 per 100 woman-years (95% CI 0.27-8.07). Although 9/30 Mirena removals were followed by re-insertion, only the first segment of use is analysed. CONCLUSION: As this is a pilot study, no firm conclusions can be drawn, but our preliminary results suggest that any increased pregnancy risk, if it exists, falls within acceptable bounds.