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Hormonal implants: contraception for a new century.

Subdermal implants are contraceptive systems that release low, stable amounts of synthetic progestins from Silastic or other materials for periods of months to several years. Unlike other hormonal delivery systems, they do not cause unnecessary peaks in progestin levels and do not use estrogens, and thus their health risks are minimal. Norplant has been studied more extensively than any other subdermal contraceptive implant. More than 60,000 women have participated in clinical trials, which demonstrated that this approach is one of the most effective reversible contraceptive methods available (1% pregnancy rate in 5-year users). The implant also reduces the incidence of ectopic pregnancy to a level much below noncontraceptive users and about equivalent to TCu380A intrauterine device users. Exposure to the sustained, low dose of levonorgestrel delivered by Norplant has shown only minor metabolic changes. Side effects are minor but often bothersome, causing some discontinuation of the method. First-year continuation rates range from 76% to 90%. Fertility return after discontinuation is prompt. Difficulty in removal of the implant capsules by the less experienced practitioner has motivated researchers to develop systems that are easier to use, less obvious under the skin, and biodegradable. The Norplant 2 system is faster, easier, and less painful to insert and remove. Implants under investigation release desogestrel and other progestins; Capronor and subdermal norethindrone pellets are biodegradable systems.

Contraceptive Agents, Female↗

[Electronmicroscopical aspects of endometrial distrophy induced by oral contraceptives (author's transl)].

An electron-optical study on the endometrium of 5 controls and 25 patients subjected during 3-12 months to 0.25 mg norgestrel + 0.05 mg etinil-estradiol association treatment is performed. The most prominent electronmicroscopical features of endometrial changes are described, such as the asynchronical maturation of the epithelium and the stroma, the shorthening of the proliferative and secretory phases and the epithelial involution towards the last days of the cycle. Special emphasis is placed on the zonal distribution of these changes. An increase of the nostocitosis phenomena is reported and its significance as a complementary contraceptive mechanism is discussed.

Endometrium↗

Complete and robust ovulation inhibition with NuvaRing.

NuvaRing, a novel contraceptive vaginal ring, releases 15 microgram of ethinylestradiol (EE) and 120 microgram etonogestrel (ENG) per day. A randomized pharmacokinetic study compared NuvaRing with a combined oral contraceptive (COC) containing 30 microgram EE and 150 microgram desogestrel. Maximum levels of EE and ENG with NuvaRing were 30% and 40%, respectively, of those seen with the COC. Because ENG bioavailability was higher following vaginal administration, the systemic progestogen exposures were comparable with the two contraceptives. However, the EE bioavailabilities were similar with both routes and so EE exposure with NuvaRing was half that with the COC. Pharmacodynamic studies have examined ovarian function during recommended and altered NuvaRing use. The use of NuvaRing for the recommended 3-week period completely inhibited ovulation. During an additional 2 weeks of use, ovulation continued to be inhibited. Early NuvaRing removal after just 3 days had no effect on the time to ovulation compared with recommended use, thus indicating that 3 days of use seem to be sufficient to suppress ovarian activity. Finally, delayed ring insertion (when the follicles had developed to 13 mm) resulted in inhibition of ovulation in all women. In conclusion, NuvaRing effectively inhibits ovulation during recommended and altered use, showing that it is a robust contraceptive method.

Biological Availability↗

Contraception and therapy with Tri Regol tablet.

Tri Regol has been used as a contraceptive during 541 cycles of 108 women and in further 73 cases for normalizing cycle anomalies or improving tablet tolerance. Pregnancy did not occur. The side-effects were insignificant. The triphasic therapy proved to be effective in all three fields. The author has mentioned the critical attitude towards oral contraceptives and calls the attention to the importance of an objective evaluation of the usefulness of these tablets. He emphasizes that the use of the multiphasic, low-dose pills is at present most up-to-date contraceptive method.

Adolescent↗

Pregnancy with an intrauterine device in situ and preterm delivery.

We determined the prevalence of preterm delivery in a population of women who conceived with an IUD in situ and compared the results with those in a group of women without any contraceptive method. The study group consisted of 16 women who conceived with a copper IUD in situ. The control group comprised 48 women matched for age, gravidity and parity. The prevalence of preterm delivery was significantly higher in the study group than in the control group (18.7% (3/16) vs 2% (1/48)), respectively. (P = 0.045, Fisher's exact test.)

Adult↗

Trisomy 7 mosaicism and manifestations of Goldenhar syndrome with unilateral radial hypoplasia.

We describe a girl born to a mother who took birth control pills and antihistamines during the first trimester of pregnancy. Congenital abnormalities included plagiocephaly, abnormalities of left ear, facial asymmetry, abnormalities of head hair pattern, cleft lip and palate, bifid tongue, left torticollis, hemivertebrae, left radial hypoplasia and absent thumb, left inguinal hernia, patient ductus arteriosus, narrowing of the thoracic aorta, and hypoplastic right pulmonary artery. The karyotype obtained from peripheral lymphocytes and from fibroblasts from the left side of the body was 46XX whereas fibroblasts from the right side revealed 46XX/47XX+7 mosaicism.

Child↗

[Prospective study of the efficacity of a recent symptomatic-thermal method of natural family planning].

UNLABELLED: A Belgian pilot-study conducted in the framework of the prospective European multi-center study (University of Düsseldorf) tried to establish the use-effectiveness (a sine qua non condition for its acceptance in Europe) of natural family planning. MATERIAL AND METHODS: 84 participants provided data (sympto-thermal chart and related information) on 1,750 cycles where family planning intention was to avoid a pregnancy. The average age of the women was 32 years. A contraceptive method (mainly oral contraceptives) was employed previously by 61% of them. The sympto-thermal method used by the test group highlights the beginning and the end of the menstrual cycle's fertile period by a double check. As to the start of the fertile period, the criteria are: a calculation on the length of the previous twelve cycles and the first sign of mucus at either the vulva or the cervix. Indicators of the end of this phase are: the third day of high temperature and the fourth evening after either the peak mucus day or the peak cervix day. 75% of the women involved generally use the cervical auto-palpation. RESULTS: No method failure at all has been detected. Two unplanned pregnancies occurred due to user failure. The total Pearl index for the study was 1.4. When examining only those cycles (85% of the reported cycles) where no protected sexual intercourse occurred during the fertile phase, practical efficacy of the method analysed was 1.8 according to Pearl index. Furthermore, taking into account protected and unprotected sexual intercourse occurred during the fertile phase, we observed that sexual abstinence was practised during the "risk" period of 75% of the cycles. CONCLUSIONS: The results of this test study demonstrate the practical efficiency of a modern natural family planning method. The high level of cycles during which periodic abstinence was employed testify to the acceptability of the method used.

Adult↗

Effective, despite misconceptions. The IUD with progesterone must be replaced once a year, while the IUD with copper may be left in for up to 10 years.

Many women have misconceptions about the intrauterine device, or IUD. The IUD is a safe and effective contraceptive method for many women. It is more effective than the condom, diaphragm, or spermicides, and also is more convenient than these methods, since it doesn't interfere with different sexual activities. The IUD is a small, T-shaped plastic device containing either copper or progesterone, and is inserted by a doctor into a woman's uterus. A thin plastic thread (1-2 inches long) protrudes through the cervix so that the user can cross-check to make sure the device is in place. Depending on the IUD type, small amounts of copper or progesterone are slowly released to prevent fertilization of the egg, or to prevent a fertilized egg from attaching to the uterine wall. The IUD with progesterone must be replaced once a year, while the IUD with copper may be left in for up to 10 years. The IUD is a good choice for women who can't take oral contraceptives and for women who have completed their families but want surgical sterilization. Because the IUD carries a slightly higher risk of ectopic pregnancy (a fertilized egg that implants outside the uterus), it is not usually recommended for women who already are at increased risk of the condition, such as those who have had a pelvic infection, a previous ectopic pregnancy or multiple sex partners. Common side effects of the IUD include some discomfort while the IUD is being inserted and some cramping and spotting during the first few weeks after insertion. Menstrual periods usually become slightly longer and heavier in women using the copper IUD, but become lighter in women using the progesterone IUD. Occasionally, the IUD will slip partially out of the uterus or be expelled entirely in the first few months.

Contraception↗

Complications of use of intrauterine devices among HIV-1-infected women.

BACKGROUND: A WHO expert group and the International Planned Parenthood Federation recommend against use of intrauterine devices (IUDs) in HIV-1-infected women based on theoretical concerns about pelvic infection and increased blood loss. We investigated whether the risk of complications after IUD insertion is higher in HIV-1-infected women than in non-infected women. METHODS: 649 (156 HIV-1 infected 493 non-infected) women in Nairobi, Kenya, who requested and met local eligibility criteria for insertion of an IUD were enrolled. We gathered information on IUD-related complications, including pelvic inflammatory disease, removals due to infection, pain, or bleeding, expulsions, and pregnancies at 1 and 4 months after insertion. Patients' HIV-1 status was masked from physicians. FINDINGS: Complications were identified in 48 of 615 women (11 [7.6%] HIV-1-infected women, 37 [7.9%] non-infected). Incident pelvic inflammatory disease (two [1.4%] HIV-1 infected, one [0.2%] non-infected) and infection-related complications (any tenderness, removal of IUD for infection or pain; ten [6.9%] HIV-1 infected, 27 [5.7%] non-infected) were also rare and similar in the two groups. Complication rates were similar by CD4 (immune) status. Multivariate analyses suggested no association between HIV-1 infection and increased risks for overall complications (odds ratio 0.8 [95% CI 0.4-1.7]) or infection-related complications (1.0 [0.5-2.3]), adjusted for marital status, study site, previous IUD use, ethnic origin, and frequency of sexual intercourse, but a slight increase cannot be ruled out. INTERPRETATION: Our data suggest that IUDs may be a safe contraceptive method for appropriately selected HIV-1-infected women with continuing access to medical services.

Adult↗

Which teen mothers choose Norplant?

PURPOSE: The objective of this study was to determine if there are sociodemographic differences between adolescent mothers who choose to use Norplant after delivery and those who do not. We hypothesized that those adolescent mothers who are at highest risk for repeat adolescent pregnancy are least likely to select Norplant as a postpartum contraceptive. METHODS: We prospectively compared the prevalence of epidemiologic risk factors for repeat adolescent pregnancy in a group of 187 consecutively delivered 13-18-year-olds who were enrolled in a comprehensive, multidisciplinary, adolescent-oriented maternity program. The study subjects were interviewed at delivery; 100 subsequently had a Norplant inserted (Norplant users). Student's t-tests and chi-square analyses were used to compare Norplant users and refusers. RESULTS: We found no statistically significant differences between Norplant users and refusers with regard to: age, race, Medicaid, or marital or school status. Compared to Norplant refusers, Norplant users were less likely to be primiparous (79% compared to 90%; p = .04) and more likely to have poor school grades (20% compared to 7%; p = .001). Norplant users were more likely to state that they had had trouble remembering to use contraceptives in the past (32% compared to 14%; p = .005). CONCLUSIONS: These data do not support the study hypothesis and are encouraging because they suggest that Norplant may reduce repeat pregnancy among adolescent parents.

Adolescent↗