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Sponge versus diaphragm for contraception: a Cochrane review.

The contraceptive vaginal sponge was developed as an alternative to the contraceptive diaphragm. Unlike the diaphragm, the sponge can be used for more than one coital act within 24 h without the insertion of additional spermicide, and it does not require fitting or a prescription from a physician. We conducted a systematic review of randomized controlled trials that compared the vaginal contraceptive sponge with the diaphragm used with a spermicide in order to evaluate the efficacy and continuation rates of the two devices. The sponge was statistically significantly less effective in preventing overall pregnancy than was the diaphragm in the two trials that met our inclusion criteria. The 12-month cumulative life table termination rates per 100 women for overall pregnancy were 17.4 for the sponge versus 12.8 for the diaphragm in the larger US trial, and 24.5 for the sponge and 10.9 for the diaphragm in the UK trial. Similarly, discontinuation rates at 12 months were higher with the sponge than with the diaphragm [odds ratio 1.3; 95% confidence interval (CI) 1.1-1.6]. Allergic-type reactions were more common with the sponge in both trials, although the frequency of discontinuation for discomfort differed in the two trials. Other randomized controlled trials will be needed to resolve the role of spermicides in preventing sexually transmitted infections or in causing adverse effects.

Contraceptive Devices, Female↗

Intravaginal controlled administration of flurogestone acetate I: Development of a stability-indicating liquid chromatographic method and stability kinetics of flurogestone acetate.

Flurogestone acetate is a synthetic progestin useful for estrus synchronization in sheep. The estrus synchronization is achieved by inserting the drug-impregnated vaginal sponge in the sheep for up to 15 d, during which time flurogestone acetate is administered continuously by intravaginal absorption to suppress estrus and ovulation. The sponge is then withdrawn to regain estrus within 2-4 d. A review of the literature suggests that the analytical methods currently available are not specific, sensitive, and rapid enough. A stability-indicating high-performance liquid chromatographic method was developed, which is capable of characterizing the stability kinetics of flurogestone acetate under various environmental conditions and quantifying the release and absorption profiles of the drug from the vaginal sponges.

Animals↗

Physiological limits to further improvement in the efficiency of oestrous synchronization in goats.

The variability between animals in the timing of oestrus after administration of a synchronization treatment seems to explain the low rate of fertility in goats inseminated at a predetermined time after progesterone withdrawal. Two experiments were performed during the breeding season to test whether the variation was due to the exogenous hormone regime or to the endogenous physiology of the animals. Twenty-one goats were given a synchronization treatment consisting of a vaginal sponge impregnated with 45 mg of fluorogestone acetate (FGA) for 11 days associated with intramuscular injection of 400 I.U. of equine chorionic gonadotrophin (eCG) and 50 microg of cloprostenol 48 h before sponge removal. Progesterone concentrations were measured during the subsequent cycle and the patterns were modelled to allow precise determination of the onset of luteolysis. Oestrus and the luteinizing hormone (LH) surge began 33.0+/-6.8 h and 76.0+/-33.0 h after sponge withdrawal, v. 43.4+/-5.7 h and 90.0+/-36.0 h after natural luteolysis. For both observations, the between-goat variability was larger during the natural than during the synchronized oestrus (P < 0.05). The duration of the oestrous cycle was independent of the number of corpora lutea (CL), whereas the duration of luteal phase was shorter in goats with 2-3 CL (16.4+/-0.9 day than in those with 1 CL: 17.7+/-1.3 day; P < 0.05). In the second experiment, 20 goats were ovariectomized and given a vaginal sponge as described above. Sixteen h after sponge removal, they were injected with 50 microg of oestradiol benzoate (ODB). This treatment was repeated with the second sponge being inserted 1-2 days after observation of oestrus. Oestrus and LH surge were observed: 32.8+/-6 8 h v. 27.8+/-7.8 h after the first ODB injection, and 36.6+/-7.3 h v. 34.3+/-4.8 h after the second ODB injection. No relationship was observed between data of the two experiments. In both cases, the variability in the occurrence of oestrus and LH surge was of the same order as observed in the first experiment. This study shows that the timing of oestrus and LH surge is less variable after progestagen treatment than during a natural oestrous cycle. Moreover, a significant proportion of variability is inherent in the delays following the oestradiol peak, suggesting that further improvement in the synchronizing capacity of treatment based on progestagen administration is unlikely.

Animals↗

Contraception in the adolescent: an update.

Contraception remains an important part of national efforts to reduce adolescent pregnancy in the United States. A number of safe and effective contraceptive methods are available for our youth, including abstinence, barrier methods, oral contraceptives, Depo-Provera, and Norplant. Research over the past few decades has resulted in a variety of oral contraceptives with reduced amounts of hormones and reduced side-effects. A number of methods have received approval by the Food and Drug Administration since the last review in 1980, including emergency contraceptives, depomedroxyprogesterone acetate, and the cervical cap. The use of condoms and vaginal spermicides continues to be recommended for all sexually active adolescents to reduce (not eliminate) the risk for acquiring sexually transmitted diseases. A polyurethane condom is now available, in addition to the latex condom and other barrier contraceptives, including the following: diaphragm, cervical cap, vaginal sponge, female condom and vaginal spermicides. Because of continuing concerns about pelvic inflammatory disease related to intrauterine devices, currently available intrauterine devices are not recommended for most adolescents. Abortion is not considered as a contraceptive method.

Adolescent↗

Abdominal sacral colpopexy resulting in a retained sponge. A case report.

BACKGROUND: During abdominal sacral colpopexy, a procedure used to correct vaginal vault prolapse, the vaginal cuff must be elevated intraabdominally to facilitate suturing. The use of a vaginal sponge stick to elevate the cuff can result in foreign body complications. CASE: A 70-year-old woman developed chronic pelvic pain and a vaginal discharge after undergoing abdominal sacral colpopexy. Radiographic films showed what appeared to be a retained surgical needle in the vaginal cuff. During an exploratory laparotomy to remove the foreign body, a fragment of the sponge used to elevate the vaginal cuff during abdominal sacral colpopexy was found to have been inadvertently incorporated into the apex of the vagina. CONCLUSION: An end-to-end anastomotic sizer should be used to elevate the vaginal cuff during abdominal sacral colpopexy to reduce the risk of foreign body complications.

Aged↗

Vaginal mechanical contraceptive devices.

The alleged adverse effects of oral contraceptives and intrauterine devices have led to increased consumer and physician demand for vaginal contraceptive devices. The efficacy and the advantages and disadvantages of vaginal sponges, cervical caps and diaphragms are discussed and compared in this article.

Contraceptive Agents, Female↗

Contraceptives of the future in the light of HIV infection.

The AIDS and sexually transmissible disease pandemics have helped to focus the world's attention on the need for good protection against transmission of infections during sexual intercourse. Most of the highly effective modern contraceptives provide only limited protection against STD transmission, although recent progress with the development of loose-fitting plastic male condoms and new spermicides gives some hope. Urgent attention must continue to be given to contraceptives with STD protective qualities which are under the woman's control. Refinements of the female condom and vaginal sponges with new spermicides and microbicides may be a step in this direction.

Acquired Immunodeficiency Syndrome↗

The progestagen releasing vaginal ring.

The results of the Manchester study and its reinforcement from data from the multicenter study indicate that the ring is a well-tolerated delivery system for low-dose progestagens. The expulsion rate is low and vaginal tolerance satisfactory. The pregnancy rate and bleeding pattern is of the same order as oral low-dose progestagens. Indeed, there is an indication that the pregnancy rate and abnormal bleeding rate may be even lower. Data from other more extensive phase 3 studies will be required to confirm this impression. The subjective assessment is that the majority of patients are enthusiastic about this method of contraception, bearing in mind that many of them had become disenchanted with existing marketed contraceptive methods. Because of its high level of acceptability, the gap between theoretical and use-effectiveness in narrowed and once inserted, a high degree of motivation is not required since the existing ring only needs to be reinserted after 90 days of use. The acceptability of vaginal methods of contraception as evidenced by the rapid uptake of the vaginal sponge suggests that there is considerable potential for increased use of vaginal methods. In the present state of knowledge, it would appear that the woman for whom the progestagen only conception is particularly appropriate is the one who is lactating or for the older woman whose fertility is on the wane. For the woman who wishes to space her family, the progestagen only contraceptive is also appropriate. With increased refinements and experience of this method, there is a likelihood that the ring may extend the use and application of progestagen only contraception to a wider range of potential patients.

Biology↗

Spermicidal activity of a new contraceptive sponge.

An open, crossover study evaluated the spermicidal efficacy and irritative potential of the Protectaid sponge. Postcoital tests were conducted in nine healthy couples under control conditions (no sponge) and with the sponge. Microscopic examination of postcoital mucus from the female partners showed that sperm entered the cervix in all nine controls, whereas entry was completely prevented by the sponge in four of nine women. None of the participants showed colposcopic evidence of mucosal irritation while using the sponge. Colposcopic abnormalities were evident in two of nine women during control testing. The urgent need for female-controlled contraceptive methods with the potential to protect against sexually transmitted diseases makes this low-dose spermicidal vaginal sponge an effective and safe alternative.

Adolescent↗

Barrier methods of contraception: a reappraisal.

In the last two years, there has been a gradual reawakening of interest in barrier methods and an increase in their usage by both men and women. This is in large part due to concern about the sometimes serious side effects reported for other contraceptive methods. The return to these techniques is particularly important, given the current epidemics of teenage pregnancy and veneral disease. One of the major problems in relation to barrier methods today is the accurate determination of their efficacy. There are very limited data with statistical validity available to judge the exact rate of effectiveness one might obtain using one of these techniques. The National Survey of Family Growth, conducted by the National Center for Health Statistics, showed a failure rate per 100 women of 16.7 for foam, cream or jelly and 15.9 for diaphragms (22). There is a great need for new and improved barrier methods of contraception. Numerous clinical studies are being set up to test spermicidal agents and vaginal sponges for the female, as well as such things as disposable condoms for males.

Adolescent↗

Reproductive management of mares without detection of oestrus.

The use of photoperiod, progestagen, prostaglandin and hCG treatments was investigated to obtain mating of mares at predetermined times. The objectives were: (1) synchronization of oestrus at an early time of the year, (2) simplification of treatment schedules by use of vaginal sponges, and (3) use of several controlled cycles by successive synchronization. The following conclusions were reached. First, after a 16 h photoperiod was applied beginning on 25 November, hormonal synchronization of oestrus and ovulation followed by cyclicity were obtained on 1 February; i.e. 2 months of light are essential as hormonal synchronization of ovulation was not obtained by 10 January. Second onset of oestrus was well synchronized after vaginal application of progestagens (3.75 days +/- 0.98 s.d. after withdrawal) and in spite of vaginal irritation, fertility was high (71%, N = 24) after mating every 48 h of the induced oestrus. Third, for synchronization of return to oestrus in mated non-conceiving mares, oral progestagens were given from Days 7 to 21 after mating. Predetermined mating (Days 27 and 29) and hCG injection (day 28) for non-pregnant animals were decided after a progesterone assay of Day 21 blood plasma. After 3 controlled mating periods, the cumulative fertility was 88% (N = 24) in non-lactating mares and 58% (N = 19) in lactating mares. Programmed reproductive management is possible in the horse.

Animals↗

Exogenous GnRH induces ovulation in seasonally anoestrous lactating goats (Capra hircus).

A specific sheep LH radioimmunoassay was validated for the measurement of goat LH, and used to monitor luteal-phase LH episodes and the preavulatory LH surge in progestagen sponge-synchronized cycling goats. No luteal-phase LH episodes were detected during 12 h of frequent (15-min) blood sampling in 2 goats. A preovulatory LH surge was recorded in 5/5 goats, with a mean amplitude of 45.4 +/- 7.2 ng/ml and a mean time of onset of 38.4 +/- 1.2 h after removal of a progestagen-impregnated sponge. In anoestrous goats, single i.v. injections of 1000 and 2000 ng GnRH induced LH episodes with a mean amplitude of 2.04 +/- 0.11 and 3.67 +/- 0.06 ng/ml respectively, but injections of 250 or 500 ng did not consistently elevate LH concentrations. Progestagen-primed, seasonally anoestrous lactating goats were treated with repeated injections of 1500 ng GnRH (every 2 h for 52 or 78 h) in May 1985 or 1986. All 10 had kidded in March of the same year, and were consequently at peak lactation at the time of GnRH treatment. A preovulatory LH surge was detected in 9 goats with a mean time of onset of 59.5 +/- 2.9 h (1985) or 39.6 +/- 3.3 h (1986) after vaginal sponge removal. All animals displayed oestrus and ovulated, and 9 of the goats were mated: in 5 of these animals pregnancies were successfully carried to term. The results show episodic LH release in response to GnRH and indicate that ovulation can be induced in seasonally anoestrous goats, even at peak lactation, and normal pregnancies may result.

Anestrus↗

Maternal deaths associated with Clostridium sordellii infection.

Clostridium sordellii is a common soil and enteric bacterium that is infrequently recovered from the vagina. We describe three women in which C. sordellii caused puerperal infection and a distinctive and lethal toxic shock-like syndrome. Patients were less than 1 week post partum and each had a single, limited focus of infection including infection associated with a retained vaginal sponge, a cesarean section operative site, and endometritis. Each patient had a distinctive course characterized by sudden onset of clinical shock marked by severe and unrelenting hypotension associated with marked, generalized tissue edema and "third spacing" with increased hematocrit, presence of marked leukemoid reaction with total neutrophil counts of 84,000/mm3, 66,000/mm3, and 93,600/mm3, absence of rash or fever, limited or no myonecrosis, and a rapid and uniformly lethal course. Hypoalbuminemia was also noted. Similar findings were noted in prior isolated reports of C. sordellii-mediated postpartum or surgical infection. Treatment of animals with C. sordellii or closely related C. difficile toxins produces similar findings. We suggest that localized infection with toxin-producing strains of C. sordellii can produce a rapidly lethal toxic shock-like syndrome. Further study and earlier recognition of this syndrome may be life-saving in other patients.

Adult↗

Genital stimulation facilitates maternal behavior in estrous ewes.

Only a small proportion of ewes at estrus have been found to respond maternally to newborn lambs, and this low maternal responsiveness may be partially attributable to the absence of the genital stimulation which occurs at parturition. Therefore, the effect of artificial genital stimulation on maternal behavior of estrous ewes was investigated. Estrus was synchronized in 33 ewes by placement and withdrawal of progestin-saturated vaginal sponges. Estrous ewes were divided into two groups, a control group and a group receiving 5 min of artificial genital stimulation, and observed following presentation of newborn lambs. Significantly more stimulated ewes licked the lamb and emitted low-pitched bleats in a 30-min test. When genital stimulation was subsequently administered to control ewes, more of them also became maternal so that the two groups were no longer significantly different. These results indicate that absence of genital stimulation is one of the factors contributing to the low maternal responsiveness of estrous ewes. They also demonstrate for the first time that artificial genital stimulation is effective in eliciting maternal behavior in nonpregnant ewes even at physiological concentrations of estradiol.

Animals↗