Four years of a comparative study with Nova T and Copper T 200 IUDS.
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Biomedical subjects
Publications and source records attributed to K G Nygren.
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In a historical prospective study covering 1970-1978, the authors evaluated the outcome of delivery to 429 parous women subsequent to a legally induced first-trimester vacuum-aspiration abortion during 1970-1975 in Uppsala County, Sweden. This outcome was compared with the outcome of delivery to 391 randomly chosen matched parous women and that of all parous women in Sweden in 1975. Confounding variables were controlled for in multiple regression analysis using infant birth weight and gestational duration as dependent variables. In this analysis, no harmful effects of vacuum-aspiration abortion were found. Pre-term deliveries and low birth weight infants did not occur more frequently after such abortions. The study did not disclose any association between vacuum-aspiration abortion in parous women and an unfavorable outcome of subsequent delivery.
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A randomized comparative trial on the clinical performance of two copper-releasing IUDs (Nova-T and Copper-T-200) was performed simultaneously in Denmark, Finland and Sweden. After three years the cumulative pregnancy rate was 1.9 for Nova-T and 5.0 for Copper-T. This difference in efficacy was statistically significant (p less than 0.001). Copper-T had a lower expulsion rate (p less than 0.05) in the total series but not in postmenstrual insertions. Differences between the two devices in other termination rates were not statistically significant. Analysis according to age and parity demonstrated that the pregnancy rate of Nova-T was lower than that of Copper-T in every age and parity group. The pregnancy rate of Nova-T was not effected by age or parity whereas the pregnancy rate and the expulsion rate of Copper-T decreased with increasing age and parity. The removal rate because of infection decreased markedly after the first year of use for both devices. The cumulative rate of removals for infection during the three years of use was not significantly correlated to age and there was no correlation to parity. The continuation rates increased with age and parity. The continuation rates of nulli- and primiparous women were almost identical with both devices and lower than continuation rates of women with 2 or three or more children. Only 11% of the women were lost to follow-up during 36 months. Nova-T had superior effectiveness in preventing undesired pregnancies when compared with Copper-T. The performance of Nova-T is less affected by age and parity then the performance of Copper-T. The silver core in copper wire gives a prolongation of the life-span for Nova-T. For these reasons, Nova-T appears to meet the requirements for an ideal IUD.
A new prostaglandin E2 derivative (Sulprostone) was given extra-amniotically to 17 healthy women, who were 7-8 weeks pregnant, in order to assess the plasma profile of HCG, 17 beta-estradiol (E2), and progesterone and to evaluate the effectiveness and overall acceptability of the method in relation to different dose levels. On the lowest dose level (5 micrograms) only 3 of 7 patients aborted within a 3-to 6-day period. At higher dose levels (10 and 15 micrograms, respectively) 9 out of 10 women exhibited clinical evidence of an abortion. In the group who aborted, E2, progesterone, and HCG decreased continuously, whereas in the nonabortion group decreased levels were found 3 and 6 h after administration of the drug, but already after 24 h the values had again increased. Practically all treated women experienced lower abdominal discomfort, 7 (41%) reported the pains being severe. Vomiting and/or diarrhea occurred in 4 patients (24%). Similarly to other hitherto tested prostaglandins in humans, this new analogue exhibits its effect primarily through direct stimulatory effect on the uterine smooth muscle, resulting in subsequent decline in the concentrations of HCG, E2, and progesterone. In the group of successful inductions the decrease of the HCG concentration was close the half-time of HCG, indicating a permanent damage to the placenta. Despite the high success rate at a dose of 10 micrograms or more, the side effects, mainly abdominal cramps. were too severe to make this method feasible for the induction of early abortion when comparing to the available routine procedure of rapid vacuum curettage used on an outpatients basis.
In an attempt to reduce the incidence of infectious complications after first trimester legal abortion 199 healthy, early pregnant women were treated with chloroquinaldol (SterosanR vaginal jelly) during six days before their vacuum aspiration. A group of 291 women served as control. In the treatment group 18 women (9%) had a postoperative gynecological infection while this condition was found in 37 women (12.8%) in the control group. This difference is not statistically significant. The authors conclude that preoperative prophylactic treatment with Sterosan vaginal jelly does not seem to reduce postoperative infectious complications after first trimester legal abortions.
A random assignment comparative study between Nova T and Copper T 200 after two years of use revealed that the Nova T resulted in a significantly lower pregnancy rate than the Copper T. The study was performed simultaneously in Denmark, Sweden and Finland. The pregnancy rate in Nova T users was lower than in Copper T users in every country and in every age and parity group. There was no clinic effect in the pregnancy rate of Nova T users. The other termination rates of these two devices were not significantly different. The first segment continuation rates at two years of postmenstrual insertions were 64.7 for Nova T and 65.5 for Copper T 200. It seems that Nova T is an improved copper-releasing IUD.
During a period of 4 years, 1974-77, in Uppsala county; Sweden, 203 women underwent surgery for ectopic pregnancy with histological proof of the diagnosis. For the female population of fertile age this corresponds to 0.11 ectopics per 100 women 15-44 years of age, or 1.08 per 100 notified pregnancies, or 1.53 per 100 births. Fifty-five of the women with ectopic pregnancy were using an intrauterine device (IUD) (48 a copper-bearing IUD and 7 some other type of device), and 6 women used a low dose progestogen contraceptive. For users of copper-bearing IUDs the risk of an ectopic pregnancy was estimated to be 0.15 per 100 women years. When comparing this latter risk rate with the overall incidence rate of 0.11, it must be observed that the populations forming the denominator in these two rates differ with respect to some crucial characteristics. Nulliparity and predisposing factors were found statistically significantly more often in non-IUD-users with an ectopic pregnancy than in IUD-users. Such predisposing factors may be less prevalent in IUD-users, as in other populations. This may explain why ectopic pregnancy has been found to occur less frequently than theoretically expected among IUD-users. The "ectopic preventing" capacity of the IUD may therefore be considerably lower than has been previously claimed.
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A randomized study was conducted simultaneously in three countries to compare the clinical performance of two new IUDs, the Nova-T and Copper-T-200. Forty-four persons, midwives, general practitioners, residents and specialists in obstetrics and gynecology inserted 907 Nova-Ts and 936 Copper-Ts. The pregnancy rate of Nova-T (0.7 at one year) was significantly lower than that of Copper-T (2.2 at one year). No significant differences were observed in other termination rates. The continuation rates were 72.6 for Nova-T and 71.3 for Copper-T-200. The total experience was based on 18,035 woman months of use, with a lost to follow-up of less than 7 per cent for both IUDs.
A randomized comparative study between Nova-T and Copper-T-200 was performed simultaneously in Denmark, Finland and Sweden. The results of 741 postmenstrual insertions with Nova-T and 780 with Copper-T are reported. The pregnancy rate of Nova-T was lower in every age and parity group. The pregnancy rate of Copper-T-200 varied in participating countries, whereas the pregnancy rate of Nova-T was equally low in every country. The termination rate because of expulsion with Nova-T was less affected by age and parity than that of Copper-T. Significant differences in the continuation rates with the same device were found between countries. Removals because of infection showed that women below 25 years of age had a high risk for infection regardless of parity.
Retinol-binding protein, prealbumin, and sex steroid plasma levels have been estimated daily in four women during the course of a normal menstrual cycle and in three women during treatment with combined oral contraceptives. The retinol-binding protein level showed a bicyclic variation during the menstrual cycle, whereas for prealbumin no consistent pattern of variation was observed. Oral contraceptive therapy induced a significant increase of retinol-binding protein which was correlated with the increase of vitamin A. The increase was about 35% for the formulation containing synthetic estrogen as compared with 15% for the one with natural estrogen. In relation to retinol-binding protein, the plasma level of prealbumin showed a less rapid increase but the final increment after oral contraceptive therapy appeared to be of the same magnitude for both proteins.
The authors suggest expressing the amount of use of contraceptives in a female population in the same terms as used to denote the occurrence of births, with one year of contraceptive use regarded as an event in the same sense as a birth. If the prevalence of contraceptives in a population can be expressed in the same terms as other events associated with reproduction, such as births and abortions, it may help to clarify the relationships between these events. Applying the method used to calculate the total fertility and abortion rates on the use of oral contraceptives and intrauterine devices in Sweden in 1975, they noted 1.8 deliveries, 0.6 legal abortions and seven years' use of oral contraceptives and six years' use of intrauterine device per women.
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Two copper-releasing IUDs were compared in a randomized study performed simultaneously in Denmark, Finland and Sweden. Pelvic infections were carefully observed and the IUDs removed when these were diagnosed. The overall removal rate because of infection was low during the year. The rates were the same with each device overall and in different age and parity groups. The rate was higher in women under 25, in nulliparae and primiparae but lower in the 25-29 age group, in those over 35, and in women having two or more children. The insertion was performed always during menstruation or few days after. It seems that the removal rate because of infection reflected the sexual behaviour of women more than the parity or the use of an IUD.
A radioimmunoassay for the measurement of estradiol in human milk is evaluated. The detection limit was found to be 25 pg. of estradiol per milliliter of milk. In milk samples collected from four lactating women during three to four months and from one pregnant and lactating woman, the concentration of estradiol was found to be below the detection limit of the assay. When six lactating women were given vaginal suppositories containing 50 or 100 mg. of estradiol, it was possible to estimate the estradiol concentration in milk. A ratio of transfer of estradiol from plasma to milk during physiologic conditions is calculated to be less than 100:10.