Contraception
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Unintended pregnancies account for about half of all pregnancies in the United States and, in 1995, numbered nearly 3 million pregnancies. They pose appreciable medical, emotional, social and financial costs on women, their families and society. The US is not attaining national goals to decrease unintended pregnancies, and little is known about effective means for reducing unintended pregnancy rates in adults or adolescents. ⋯ Existing studies suffer from appreciable threats to internal validity and loss to follow-up and are extremely heterogeneous in terms of populations studied and outcomes measured. The quality of the existing research does not provide strong guidance for recommendations about clinical practice but does suggest directions for future investigations. Numerous issues warrant rigorous investigation.
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Clinical Trial
A short-term evaluation of semen and accessory sex gland function in phase III trial subjects receiving intravasal contraceptive RISUG.
Following the intravasal injection of a new male contraceptive RISUG (reversible inhibition of sperm under guidance) in volunteers, routine semen analysis, semen biochemistry and germ cell morphology were evaluated in comparison with the corresponding preinjection samples for a maximum period of 6 months. Sperm counts in all 25 subjects before injection varied from 45 to 120 x 10(6)/ml. Out of 25 subjects, 6 became azoospermic after 1 month, 15 after 2 months, 3 after 3 months and 1 after 4 months of contraceptive injection. ⋯ Neutral alpha-glucosidase, the biochemical marker for epididymis, was estimated to be significantly lower in the seminal plasma of all the postinjected subjects. On the other hand, acid phosphatase activity and fructose levels in the seminal plasma were found to be in the normal range. Based on the above findings, it is concluded that at least for the present study period, RISUG, a new male contraceptive, is effective as a partially occluding agent in the vas deferens.
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The study was conducted to assess the prevalence of sensitization to latex in a group of women with a high risk for atopy and to determine whether the use of condoms is a relevant risk factor. In a prospective study, 100 atopic women (defined as having specific IgE to common aero- or nutritional allergens) were screened for specific IgE antibodies to latex after delivery: Ten of the 100 women (10%) showed specific IgE to latex. ⋯ Our results indicate that prior use of condoms does not appear to be a specific risk factor for sensitization to latex in post-partum women at high-risk for atopy. Latex-free condoms should only be recommended to women already known to be sensitized to latex.
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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.