Randomised controlled trial assessing the acceptability of GyneFix versus Gyne-T380S for emergency contraception.
(2003)
Journal - The journal of family planning and reproductive health care / Faculty of Family Planning & Reproductive Health Care, Royal College of Obstetricians & Gynaecologists (England )
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.
| ISSN : | 1471-1893 |
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| Mesh Heading : | Adolescent Adult Drug Delivery Systems Emergency Treatment Female Humans London Pain Pain Measurement Pregnancy State Medicine Uterine Hemorrhage adverse effects classification epidemiology etiology epidemiology etiology |
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| Mesh Heading Relevant : | Intrauterine Devices, Copper Patient Acceptance of Health Care methods |
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Comparative trial of the force required for, and pain of, removing GyneFix versus Gyne-T380S following randomised insertion.
(2003)
Journal - The journal of family planning and reproductive health care / Faculty of Family Planning & Reproductive Health Care, Royal College of Obstetricians & Gynaecologists (England )
Abstract :
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.
| ISSN : | 1471-1893 |
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| Mesh Heading : | Adolescent Adult Device Removal Emergency Treatment Female Humans London Pain Patient Acceptance of Health Care Pregnancy State Medicine Torque methods adverse effects classification classification |
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| Mesh Heading Relevant : | Intrauterine Devices, Copper Pain Measurement adverse effects etiology |
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