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Bacterial flora of the cervix in women using an intrauterine device.

The cervical bacterial flora of 18 healthy, parous, sexually active women was analysed before, and 3-5 months after insertion of a copper-releasing intrauterine device (IUD) and after long-term use of an IUD for 3-5.5 years in another nine women. No significant differences were found in the number of aerobic bacteria isolated before or after IUD insertion or after long-term use of an IUD. In contrast to aerobic bacteria, significantly more anaerobes were isolated in the cervix of women having used an IUD for several years when compared to those using barrier contraception with a condom. None of the women had clinical signs of pelvic infection and a cervical bacterial flora rich in anaerobes can be regarded as a normal finding in healthy sexually active women using an IUD for contraception.

Adult

[Benign intracranial hypertension and thrombosis of the venous sinuses during contraceptive treatment: anatomo-clinical and neuroradiological observations (author's transl)].

The side-effects of oral contraceptives on the nervous system have been studied in 2 patients. The first case, a young woman who, after several years, of cyclic consumption of 4 mg of norethylsterone acetate and 0.05 mg of ethynilestradiol, died from a transtentorial temporal hernia due to severe intracranial hypertension. Angiography, and later autopsy, showed thrombosis of the dural venous sinuses and also of the majority of the emissary veins with C.S.F. blockage. The second case, a patient who took 1 mg of norethyndrone and 0.05 mg of mestranol for 20 months, developed a focal symptomatology (Grand Mal, global aphasia without lowering of the level of conscionsness) which cleared up rapidly. The CAT performed during the clinical illness showed mild signs of intracranial hypertension while cerebral angiography normal. It seems possible that the hormonal treatment may disturb the mechanisms of C.S.F. production-reabsorbtion and the filtration dynamics of the blood-brain barrier and perhaps, cause alteration of hypothalamic-hypophysial function. This would explain a transitory symptomatology, such as benign intracranial hypertension. However, the thrombosis of the venous sinuses (sometimes, as in our first case, massive) may be due to the venous stasis, that accompanies intracranial hypertension and to the altered blood coagulation.

Adult

Trends in ectopic pregnancies and use of intrauterine devices in Lombardy, Italy 1979-1983.

The frequency of ectopic pregnancies in Lombardy (a region in Northern Italy with a population of about 9 million inhabitants) over the period 1979-1983 was estimated using the Regional Hospital Discharge Registration System, where information is collected on all discharges from public and private hospitals. The ratio of ectopic pregnancies rose from 4.43/1000 pregnancies in 1979 to 4.93/1000 pregnancies in 1982 and flattened off in 1983 (4.78/1000 pregnancies). The frequency of ectopic pregnancies increased with maternal age from 2.30/1000 pregnancies in teenagers to 6.01/1000 pregnancies in women 30-39 years old, but remained constant thereafter (5.84/1000 pregnancies in women aged 40 or older). These trends were consistent with available information on intrauterine device (IUD) sales over the same calendar period. On the basis of a random subsample of the same dataset, we evaluated by means of a case-control approach, the relative risk of ectopic pregnancy in relation to IUD use. Current IUD users had an estimated age-adjusted relative risk of ectopic pregnancy of 3.6 (95% confidence interval = 1.4-8.0) in comparison with an hospital-based control group of non-pregnant women. In etio-pathological terms, the interpretation of this finding is not obvious since it is possible that IUD users are simply less protected than pill, barrier or other traditional method users against ectopic pregnancy. Nonetheless, on a public health scale, the impact of IUD on the incidence of ectopic pregnancy should be evaluated in relative terms of comparison with other methods and their utilisation in different populations.

Adult

Plasma reduced and total ascorbic acid in healthy women: effects of smoking and oral contraception.

This is the first report of both reduced (RAA) and total (TAA) plasma ascorbic acid levels in women who smoke and are on oral contraception. 155 normal healthy subjects were investigated. A study questionnaire was completed including age, method of contraception, smoking status, and food intake at breakfast, prior to attending the clinic. Biochemical assays were promptly carried out without knowledge of subject's clinical or dietary status. One-way analysis of variance revealed that oral contraception per se, barrier or IUD methods have no effect on plasma ascorbic acid levels. The mean values (mg/dl +/- SD) for plasma RAA between smokers and nonsmokers were 0.512 +/- 0.241 and 0.601 +/- 0.263; and that for TAA were 0.565 +/- 0.232 and 0.682 +/- 0.231, respectively. Significant decreases in both plasma RAA (p less than 0.05) and TAA levels (p less than 0.001) were observed in smokers. Age was an interacting variable. No association of smoking or oral contraceptive use was seen with RAA or TAA levels among women less than 26 years, but decreases in both RAA and TAA levels were evident among smokers aged 26 years or older. The present study emphasizes the total exposure to smoking, e.g., pack years, is a significant confounding variable in the study of plasma ascorbic acid levels.

Adolescent

The effect of the intrauterine contraceptive device on endometrial secretory function: a possible mode of action.

The effect of the intrauterine contraceptive device (IUD) on the composition of endometrial secretion has been studied using the monoclonal antibody D9B1. The antibody binds to a polypeptide-associated oligosaccharide epitope that is secreted by endometrial epithelium in the secretory phase with a maximum around the time of implantation. In endometria affected by the IUD in situ, a significant reduction in epitope expression has been observed using immunohistochemistry. This defect can occur against a background of normal secretory differentiation and in the expectation of normal ovarian stimulus. The data provide new insight into the contraceptive mechanisms of action of the IUD.

Adult

The effects of a progestin-only oral contraceptive (levonorgestrel 0.03 mg) on breast-feeding.

This study was a non-randomized clinical trial which compared the breast-feeding experience of 250 Argentine women taking levonorgestrel 0.03 mg daily (begun one week after delivery) with that of 250 women using non-hormonal contraceptives. Weight gain of unsupplemented infants, the most important of the several criteria used to assess breast-feeding performance, was similar for the two contraceptive groups. Levonorgestrel users began supplementary feeding of their infants significantly later than did non-hormonal users; levonorgestrel users were also somewhat less likely to discontinue breast-feeding during the study period. The two contraceptive groups were similar with regard to several other measures of breast-feeding performance: growth of all infants (regardless of supplementation), patterns of contraceptive discontinuation, mothers' subjective impressions of breast-milk sufficiency, and comparison of supplementation initiation with previous experience.

Adult

Oral contraceptive use and cervical intraepithelial neoplasia.

To explore the somewhat controversial relationship between oral contraceptives and pre-invasive cervical cancer, 103 cases of biopsy-confirmed cervical intraepithelial neoplasia (CIN) II or CIN III were compared with 258 controls who had normal cervical cytology. Cases were slightly less likely than controls to have ever used oral contraceptives; the odds ratio, controlling for age, socioeconomic status, barrier method use, smoking history, age at first sexual intercourse, number of sex partners, current marital status, and number of Pap smears, was 0.7 (95% CI 0.3-1.6). Recency, latency, duration, and age at first oral contraceptive use were evaluated and in no instance was oral contraceptive use positively associated with CIN. This study adds to the body of knowledge that oral contraceptives are not associated with pre-invasive cervical cancer. Further, if oral contraceptive users continue to be regularly screened, their risk of developing the more invasive lesions should be very low.

Adolescent

Fertility after contraception or abortion.

There is a very small correlation, if any, between the prior use of OCs and congenital malformations, including Down's syndrome. There are few, if any, recent reports on masculinization of a female fetus born to a mother who took an OC containing 1 mg of a progestogen during early pregnancy. However, patients suspected of being pregnant and who are desirous of continuing that pregnancy should not continue to take OCs, nor should progestogen withdrawal pregnancy tests be used. Concern still exists regarding the occurrence of congenital abnormalities in babies born to such women. The incidence of postoperative infection after first trimester therapeutic abortion in this country is low. However, increasing numbers of women are undergoing repeated pregnancy terminations, and their risk for subsequent pelvic infections may be multiplied with each succeeding abortion. The incidence of prematurity due to cervical incompetence or surgical infertility after first trimester pregnancy terminations is not increased significantly. Asherman's syndrome may occur after septic therapeutic abortion. The pregnancy rate after treatment of this syndrome is low. The return of menses and the achievement of a pregnancy may be slightly delayed after OCs are discontinued, but the fertility rate is within the normal range by 1 year. The incidence of postpill amenorrhea of greater than 6 months' duration is probably less than 1%. The occurrence of the syndrome does not seem to be related to length of use or type of pill. Patients with prior normal menses as well as those with menstrual abnormalities before use of OCs may develop this syndrome. Patients with normal estrogen and gonadotropin levels usually respond with return of menses and ovulation when treated with clomiphene. The rate for achievement of pregnancy is much lower than that for patients with spontaneous return of menses. The criteria for defining PID or for categorizing its severity are diverse. The incidence of PID is higher among IUD users than among patients taking OCs or using a barrier method. The excess risk of PID among IUD users, with the exception of the first few months after insertion, is related to sexually transmitted diseases and not the IUD. Women with no risk factors for sexually transmitted diseases have little increased risk of PID or infertility associated with IUD use. There appears to be no increased risk of congenital anomalies, altered sex ratio, or early pregnancy loss among spermicide users. All present methods of contraception entail some risk to the patient. The risk of imparied future fertility with the use of any method appears to be low.(ABSTRACT TRUNCATED AT 400 WORDS)

Abortion, Induced

Clinical evaluation of drugs used in fertility regulation.

The clinical evaluation of drugs used in fertility regulation is initially assessed in Phase I, II and III trials. The design of each phase and the investigative staff must be adequate. In Phase I, normal, healthy human volunteers meeting specific guidelines are usually studied. Numbers vary between 20 and 80 and the purpose is to determine the acute toxicity of the compound. In Phase II, efficacy and safety are examined in a clinical target population, and emphasis may be placed on pharmacological and mechanistic studies. Usually between 50 and 200 patients are involved. In Phase III, large-scale clinical studies for local registration and the introduction of drugs to various countries are included. This paper describes the evaluation of various drugs used in contraception, including NORPLANT implants, and considers the efficiency, safety and acceptability of such drugs. Phase IV studies are usually needed to reveal chronic toxicities or rare events.

Clinical Trials as Topic

Characteristics and attitudes of early contraceptive implant acceptors in Texas.

In 1991, shortly after Norplant became available in the United States, 678 women who had received the implant from 17 providers in Texas were surveyed. Forty-five percent of these women were under 21 years old. The majority (56%) had tried the implant because they were dissatisfied with their previous contraceptive method. Forty-four percent of the sample indicated that the implant was one of the first contraceptive methods they had used and that they had only recently decided to prevent unplanned pregnancy. The average number of children per woman was 1.2, and one-third of the sample had had at least one abortion. While 37% of the women said they wanted no more children, 63% said they were using the implant as a spacing method. The reasons for choosing the implant and concerns about it varied according to the user's age, educational level and race or ethnic group.

Adolescent

[Chlamydia trachomatis infection in women and the use of oral contraceptives].

We determined the prevalence of genital Chlamydia trachomatis infection in women who visited a clinic for sexually transmitted diseases (STD) and the influence of the number of partners and the use of oral contraceptives (OC), with special attention to the recognition of pelvic inflammatory disease (PID) and to the results of therapy. Of 217 women, with a mean age of 26 years (range 14-56), who visited the STD clinic of the University Hospital of Groningen from July 1985 until November 1987, anamnestic data were collected as well as the results of swabs from cervix and urethra taken for culture and direct immunofluorescence test of C. trachomatis and for gonococcal culture. The influence of the number of partners (1 versus greater than 1) and OC on the prevalence of C. trachomatis infection was evaluated by logistic regression analysis. PID was excluded in coöperation with the department of gynaecology. C. trachomatis-infected women were treated by doxycycline orally (day 1 2 x 100 mg, day 2-7 1 x 100 mg) according to the dosage scheme advised by the Dutch Health Council in 1986. A control culture was taken 2-3 weeks after treatment. C. trachomatis was detected in 72/217 (33%) women by culture and (or) direct IF test and in 22/41 (54%) women with gonorrhoea. In connection with the number of partners in the year preceding the examination, the following prevalences were found: 18/74 (24%) (1 partner), 43/108 (40%) (2-5 partners) and 10/27 (greater than 5 partners).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent

Contraception.

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Clinical Trials as Topic