[ON THE PROBLEM OF CONTRACEPTION. II. HORMONAL CONTRACEPTION].
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OBJECTIVES: To measure and compare the incidence of adverse events during use of two medicated intrauterine devices (IUDs). DESIGN: A multicenter prospective 7-year randomized study. SETTING: Family planning clinics, primarily in developing countries. SUBJECTS: Women age 18 to 38 years at admission, desiring contraception and without contraindications to IUDs. MAIN OUTCOME MEASURES: Incidence of complaints, conditions, and rates of specific termination for each IUD. METHODS: Subjects recorded menstrual events, and clinical staff registered all complaints and conditions found on examination at four first-year clinic visits and at semiannual visits thereafter. Difference in rates were analyzed by chi 2 statistics. RESULTS: Annual pregnancy rates for each IUD averaged 0.2/100 women whereas upper genital tract infection occurred at rates of 0.6 to 0.7 per 100 years of use. The levonorgestrel-releasing IUD significantly decreased bleeding and spotting days in comparison with historical data for noncontraceptors and with the copper-medicated IUD. Dysmenorrhea, vaginitis, and myoma in women with the levonorgestrel IUD were markedly decreased in comparison with the experience of copper IUD users. Significantly higher rates of amenorrhea, delayed ovarian follicular atresia, skin and hair conditions, and headache were observed with the steroid IUD than with the copper-releasing IUD. Rates of reported adverse effects for either IUD were highest in the first 2 years of use and among women under age 25. CONCLUSIONS: Long-term use of copper or levonorgestrel IUDs is characterized by very low rates of pregnancy and by a low and declining annual incidence of side effects, including pelvic infection and borderline anemia. The levonorgestrel-releasing IUD reduced the incidence of bleeding and, in the long term, of myoma and myoma-related surgery in comparison with the copper T IUD. Both IUDs proved highly acceptable and had few unanticipated side effects.
Gräfenberg introduced his silver ring in 1928 and by his classic paper, published in 1931, provided intrauterine contraception with a scientific basis. For largely non-medical reasons, the Gräfenberg ring vanished from the scene a few years later, and it took almost 30 years before the method was rehabilitated as a result of a change in mental attitude toward birth control, the awareness of world population explosion, and the introduction of improved intrauterine devices (IUDs). The United States became the epicenter of IUD research in the 1960s but, due to adverse publicity and the threat of litigation, the pendulum swung and European investigators took over the job of improving the IUD. Proceeding from Dr Gräfenberg's classic paper, the major steps in the evolution of the intrauterine devices are retraced with focus on the scientists who were innovative in the field.
In this comparative study, the five-year continuity rate of 53.7% in the Norplant implants group was comparable to that of 52.7% in the copper IUD group. The difference was not statistically significant. Only one accidental pregnancy occurred during the five years of copper IUD use. Desire for future pregnancy was the main reason for removal in the Norplant implants group (35.9%) while expulsion of the IUD (13.2%) was the main reason for removal of the copper IUD. Menstrual disturbance was not a major side-effect in either group. The post-removal conception rates of 78.6% in the Norplant implants group and 75.0% in the copper IUD were good and comparable. Both the Norplant implants and copper IUD are acceptable and effective contraceptive methods in Singapore.
Further to the investigation of the possible mode of action of the intra-uterine contraceptive device (IUCD), an assay for the beta-specific subunit of human chorionic gonadotrophin (HCG) has detected endogenous chorionic activity 21 days after menstruation. In 22 proven ovulatory cycles, 7 patients wearing an IUCD had demonstrable serum HCG levels in 45% of these cycles. Abnormal menstruation was associated with the majority of cycles in which there was HCG in the serum. Subsequent luteolysis occurred in all cases. The results of this study may support the hypothesis that IUCD exerts its effect on the fertilized, implanted blastocyst, thus causing possible 'micro-abortion'. Caution should be exercised in the interpretation of HCG values in the follow-up of patients with hydatidiform mole or choriocarcinoma who are bearing IUCDs, since positive HCG levels may be due to an early, fertilized and implanted blastocyst and not to invasive tissue.
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