Contraception
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Randomized Controlled Trial Comparative Study Clinical Trial
A comparison of techniques to assess cervicovaginal irritation and evaluation of the variability between two observers.
Colposcopy is used to evaluate effects of new vaginal products on cervicovaginal epithelium as part of the US Food and Drug Administration-mandated product approval process, yet few aspects of its use have been investigated. ⋯ The colposcopic examination is not burdensome nor does it induce findings. If naked eye observation were used alone in practice, these data suggest that half the colposcopically detected findings would be missed. Using the naked eye observation for screening would minimally reduce the number of magnified observations carried out. For detecting epithelial changes, the colposcope seems to be the most sensitive technique, followed by the AviScope.
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Randomized Controlled Trial Clinical Trial
The effect of lorazepam on pain and anxiety in abortion.
In this double-blind study, 104 women were randomized to receive 1 mg lorazepam or placebo prior to a first-trimester abortion. In addition, 262 women were allowed to choose whether or not to take the lorazepam. ⋯ In the observational group, the women who took lorazepam had their mean anxiety score drop from 5.5 to 4.7 while in those who did not take it, the score rose from 3.8 to 4.9. This study indicates that giving oral benzodiazepines preoperatively is neither helping nor hurting our patients but the placebo effect can be helpful to make our patients more comfortable.
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Randomized Controlled Trial Comparative Study Clinical Trial
Randomized crossover trial comparing the eZ.on plastic condom and a latex condom.
This randomized crossover trial compared the breakage and slippage rates, safety, and acceptability of the recently developed polyurethane bi-directional eZ.on condom with a marketed latex condom. Three hundred sixty couples were asked to use 4 eZ.on condoms and 4 latex condoms. Like several other non-latex condoms tested to date, the eZ.on condom had a higher clinical breakage rate than its latex comparator, while the slippage rates were similar. ⋯ The eZ.on was also found to be easier to don and remove than the latex condom. Although no overall preference existed for either condom, nearly 30%women and men strongly preferred the eZ.on condom to the latex condom. The eZ.on condom may be an acceptable alternative for couples unable or unwilling to use latex condoms.
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Randomized Controlled Trial Comparative Study Clinical Trial
Two randomized controlled trials comparing the Hulka and Filshie Clips for tubal sterilization.
To compare the effectiveness and safety of the Filshie Clip System and Hulka Clip System when applied via minilaparotomy and laparoscopy, we conducted 2 multicenter randomized controlled trials of 2126 women (878 in the minilaparotomy study and 1248 in the laparoscopy study) who received either the Filshie or Hulka Clip. A physician other than the operator evaluated patients postoperatively and again at 1, 6, and 12 months after surgery. We compared the cumulative incidence of pregnancy and the frequency of safety related events for the device groups. ⋯ The difference in the risk of pregnancy through 12 months between device groups neared statistical significance (p = 0.06). Among the extended follow-up subset, the 12- and 24-month cumulative pregnancy probabilities were 3.9 and 9.7 per 1000 women for the Filshie Clip group and 11.7 and 28.1 per 1000 women for the Hulka Clip group (p = 0.16 for comparison through 24 months). Both the Filshie and Hulka Clips are effective and safe for use in tubal occlusion.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A comparative study of two contraceptive vaginal rings releasing norethindrone acetate and differing doses of ethinyl estradiol.
Two combined contraceptive vaginal rings (CVR) each releasing approximately 1 mg norethindrone acetate (NET-Ac) and either 20 micrograms or 15 micrograms ethinyl estradiol over 24 h were tested at three clinic sites in Los Angeles, San Francisco, and Sydney. A total of 61 women were enrolled to use the ring on a schedule of 3 weeks in/1 week out for four treatment cycles. Serum estradiol, progesterone, norethindrone (NET), and ethinyl estradiol (EE) levels were assayed twice weekly in all four treatment cycles. ⋯ Side effects were infrequent and similar to those reported with other steroidal contraceptive methods. Three women complained of vaginal discharge, one with accompanying itch and one with a vaginal Candida infection in cycle 1. Overall, both of these EE/NET-Ac rings performed well, with only minor and mainly nonsignificant differences in effect on serum EE, NET, E2, and progesterone levels and lipids, and on vaginal bleeding patterns.