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CONTRACEPTION. 1993 Apr; 47(4):359-66.To determine whether the known adverse effects of IUD use were kept to a minimum, 432 doctors were asked to complete questionnaires about their training and practice in IUD insertion, providing information about the insertion and the patient during a 3-month period. 349 doctors returned the first questionnaire. 93% of doctors had received some formal training in IUD insertion, although 54% had performed fewer than 5 supervised insertions before carrying out an unsupervised insertion. Only 8% had performed 10 or more supervised insertions. 58% had performed only 1 or no insertions in the month before the study period. 91% of respondents carried out more than 1 pelvic examination per week. Only 12% of doctors reported always prescribing prophylactic antibiotics. More doctors routinely took vaginal and cervical swabs for culture and cervical smears. 66% of doctors routinely arranged follow-up appointments. 98% of doctors routinely gave some information to women after IUD insertion. 90% of doctors provided a description of symptoms of infection. Information about women using an IUD was obtained from 129 doctors in 460 completed questionnaires about IUD insertions. Relative contraindications to IUD use included nulliparity, a history of suspected or proven pelvic inflammatory disease (PID), a significant risk of sexually transmitted disease (STD), and uncompleted family. Excluding uncompleted family, there were 126 insertions (27%) with at least 1 relative contraindication. Gynecologists performed 30% of the insertions in cases with relative contraindications compared with 48% for other doctors. 35 women who had IUDs inserted were nulliparous, and 4 of these were aged under 20, 11 women (2%) had an IUD inserted despite a history of suspected or proved PID. 12% of the women with IUDs were not in a stable sexual relationship; 9% had a history of STD, and 28% intended to have children in the future. 5% had both a risk factor for PID and an uncompleted family.
SINGAPORE MEDICAL JOURNAL. 1989 Aug; 30(4):390-2.In the 1980s, a study showed an association between IUD use and pelvic inflammatory disease (PID) and subsequent infertility. About the same time, 2 major manufacturers of IUDs stopped making IUDs. These 2 events caused a decline in IUD use worldwide. In Singapore, however, the decline began in the 1960s when the Family Planning Board withdrew the IUD from its 5 year plan. After that, researchers in Singapore 1st conducted randomized prospective trials of most new IUDs. For example in the late 1980s, they began a prospective trial of the MLCu380 with a complicated insertion system. Multicenter trails have demonstrated that at least 5 of the newest copper IUDs have a failure rate of <2/100 woman years and <1/100 for 3 other new copper IUDs. Some manufacturers have increased the area of exposed copper from 200-250mm to 375-380mm to increase efficacy, but a prospective trial in Singapore did not show an increase. A large multicenter trial has shown that the levonorgestrel releasing IUD (LNg20) has a very low failure rate (.12/100) and reduces menstrual loss, unlike the copper IUDs. Due to legal concerns over the medical grade plastic, however, the manufacturer stopped distributing it in the late 1980s. WHO hoped to identify a manufacturer for the plastic so further trials could begin around 1991. In the late 1980s, WHO studied the silver cored copper wire IUD used to prevent fragmentation. Since IUDs change the endometrium which suppresses intrauterine pregnancies but not extrauterine pregnancies, the risk of an ectopic pregnancy is 10 times that of a nonuser. The risk is lower in copper IUDs suggesting that copper ions reduce the chance of fertilization in the Fallopian tubes. The risk of PID in IUD users ranges from 1.5-2.6. The majority of IUD associated PID occurs within 4 months following insertion and in nulliparous patients with several sexual partners.
A randomized comparative study of interval insertion of three intrauterine devices: the copper T 220c, the Nova T and the WHO levonorgestrel 2 ug IUD.
[Unpublished] 1985 May. 5 p. (Project: 82901)The objective is to compare the effectiveness and acceptability of 3 IUDs inserted in 300 health women, aged 24-38. All have had at least 1 full-term delivery. Subjects were randomly allocated to 1 of the 3 IUDS: the Copper T 220C (Tcu 220c), the Nova T, and the World Health Organization levonorgestrel 2 ug IUD. Insertion was done from the 3rd to the 5th day of menstruation between Feb. and Sept. 1984 and followed up at 48 hours, 3, 6, 12, and 24 months after IUD insertion. 12 month data was collected for cumulative rates, based on life table procedures and analyzed with log-rank test. There was no loss to follow up and no insertion failure. All levonorgestrel IUDs have been removed because the levonorgestrel-releasing IUD has a relatively high risk of ectopic pregnancy. The use-related discontinuation rates of Tcu 220c, Nova T, and levonorgestrel IUD during 12 months of use, were 11.1, 2.4, and 12.7, respectively. The difference between Tcu 220c and Nova T were statistically significant (p.<0.01). The continuation rates of Tcu 220c, Nova T, and levonorgestrel during 6 months of use were 94.0, 99.0, and 96.0, respectively. During 12 months of use, they were 88.9, 97.6, and 87.3 respectively. 1 ectopic pregnancy occurred with the levonorgestrel IUD after 7 months of use. No pregnancy occurred in Nova T users. The pregnancy rates of Tcu 220c and levonorgestrel IUD during 12 months of use were 1.0 and 1.3, respectively. Removal rates for bleeding with Tcu 220c and levonorgestrel IUD during 12 months of use were 3.1 and 1.0, respectively. The removal rate for pain with Tcu 220c during 12 months of use was 2.0. The duration of bleeding and spotting with 3 IUDs, 3, 6, 9, and 12 months of use are illustrated. Preliminary results show that the Nova T is superior to Tcu 220c and levonorgestrel IUDs. Expulsion is the main event in both Nova T and Tcu 220c. More attention should be paid to the insertion technique. The duration of bleeding and spotting of levonorgestrel IUD were longer in the last 3 months after insertion, but was shortest at 1 year of use when compared with Tcu 220c and Nova T.
Effective interception with the levonorgestrel-20-IUD contrarily to WHO advocated Lng-2-microdose IUD. Reply to letter to the editor [letter]
CONTRACEPTION. 1988 Jun; 37(6):644-6.This letter is a response to Professor Haspels' letter criticizing the World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction's clinical study of a 20 mcg microdose levonorgestrel IUD for Contraception (Contraception 1987;35: 363-79). The Population Council's International Committee for Contraceptive Research was provided with the results of the study prior to publication. The feasibility of an IUD that released a dose of progestational steroid that was pharmacologically active only on the endometrium was confirmed in a study conducted between 1980-1982 in 7 centers, only 3 of which were in developing countries. There was no evidence of effects on ovulation and no ectopic pregnancies in this study. The study itself resulted in only 8 ectopic pregnancies (6 with the levonorgestrel device and 2 with copper devices) out of 17,064 woman-years of experience. Nevertheless, the study was terminated and the results published. The polymeric delivery system used in the 2 mcg levonorgestrel IUD had undergone extensive animal toxicological studies in the US and the UK before human use. Moreover, the ethical acceptability of the study was approved by the World Health Organization as well as by local institutional ethic committees and appropriate national authorities.
Effective interception with the levonorgestrel-20-IUD contrarily to WHO advocated Lng-2-microdose IUD [letter]
CONTRACEPTION. 1988 Jun; 37(6):643.The World Health Organization's Special Program of Research, Development, and Research Training in Human Reproduction has investigated microdose administration of levonorgestrel to the uterine cavity and concluded that this approach is not safe or effective. In contrast to the excellent results obtained with 20 mcg of levonorgestrel release per 24 hours, the results of application of only 2 mcg release per 24 hours have been disappointing. There was a 6.7 increased relative risk of ectopic pregnancy with the levonorgestrel 2 IUD compared with the copper IUD, making this an unacceptable form of fertility control. On the other hand, the 12-month pregnancy rate for the levonorgestrel 20 IUD is 0.1/100 woman and the 12-month continuation rate is 80%. Removal rates for menstrual problems with this IUD are only 7.5%, and blood hemoglobin concentrations actually increase among users of the levonorgestrel 20 model.
IN POINT OF FACT 1986; (39):1-2.In 1986, the IUD was the contraceptive method chosen by over 60 million women throughout the world. In response to years of controversy related to the IUD, a World Health Organization Scientific Group met in Geneva in 1986 and determined that this contraceptive device is safe, sound, and reliable. The complications causing public concern have involved older IUDs. The new generation of copper-bearing IUDs--Multiload devices, the Copper T 220C and 380, and Nova T--are effective in preventing pregnancy for at least 5 years, and possibly for more than 10 years. Menstruation is the usual time for IUD insertion; however, the device can be safely inserted after a normal pregnancy and delivery, or after an uncomplicated miscarriage. There is no empirical evidence suggesting an association between IUD use and subsequent ectopic pregnancy. Women who use the modern copper IUDs have the lowest rates of ectopic pregnancy among IUD acceptors.
Advances in Contraception. 1986 Mar; 2(1):55-63.Based on data from case control and cohort studies, the relationships between current and past IUD use, duration of IUD use, and the type of IUD were evaluated to determine the risk of ectopic pregnancy among users. 3 studies are evaluated in this article: 1) the Women's Health Study (WHS), 2) the Oxford Family Planning Association study in the UK, and 3) a multiclinic, international study by the World Health Organization (WHO). Data from the WHS shows that women who were using IUDs at the time of their last menstrual period, and who had used their IUDs for less then 2 years, had a significantly lower risk of ectopic pregnancy compared to women who had never used IUDs; this relative risk increased to 1.7 for women who used their IUDs for 4 or more years. In 1965, there were 4 reported ectopic pregnancies among 23 women who became pregnant with a Lippes Loop in situ. Regardless of the duration of IUD use, overall IUD users were not found to be at any increased risk of ectopic pregnancy. The WHO study also indicates that IUD use does not increase the risk of ectopic pregnancy. Data from the Oxford Family Planning Association study found that while the rate of ectopic pregnancy was fairly constant over time, the proportion of all pregnancies that were ectopic increased over time. Considered collectively, the studies reviewed do not indicate that past IUD use, regardless of the type of IUD used, increases a woman's risk of ectopic pregnancy. Based on the various studies and data evaluated the following may be concluded: 1) neither current nor past use of an IUD is associated with any increased risk of ectopic pregnancy, 2) the incidence of ectopic pregnancy is similar for current users of all types of IUD, except for the Progestasert, and 3) the duration of IUD use does not increase the risk of ectopic pregnancy.
In: Long-acting contraceptive delivery systems edited by Gerald I. Zatuchni, Alfredo Goldsmith, James D. Shelton, John J. Sciarra. Philadelphia, Harper and Row, 1984. 246-7.2 principles govern the major methods of vaginal-ring release of steroids: to suppress ovulation and, the route followed by the World Health Organization (WHO), not to suppress ovulation. When ovulation is not suppressed, as with the minipill, high rates of ectopic pregnancy have been associated with the progestin-only method. Also, high rates of ectopic pregnancy have been found for an IUD that does not suppress ovulation and works as a progestin-only device. In the phase 3 ongoing study of the WHO ring in a number of centers, no ectopic pregnancies have been reported thus far. It is unclear whether the RS 37367 enters the circulation and is then secreted in the cervical mucus or whether it is taken up by osmotic, capillary, or other action into the cervical mucus. If an effect on the cervical mucus occurs after the ring has been removed from the vagina, the RS 37367 may be stored in cervical mucus and then released slowly. It appears unlikely that the compound is absorbed systemically and resecreted into mucus because the compound is rapidly metabolized by the liver, and, although radiolabeling indicates that large amounts of radioactivity are circulated in the blood by HPLC, there is no intact compound. In regard to use, there may be more expulsion of vaginal rings in cultures with squatting toilet habits. Also, there may be poor cultural acceptance of a method that requires genital manipulation. In areas where prevailing hygiene conditions are poor, a ring that has to be removed monthly or every 3 months may increase the danger of introducing infection.
In: Intrauterine contraception: advances and future prospects, edited by Gerald I. Zatuchni, Alfredo Goldsmith, and John J. Sciarra. Philadelphia, Pennsylvania, Harper and Row, 1985. 354-64. (PARFR Series on Fertility Regulation)Little data is available from developing countries on the incidence of ectopic pregnancy and the associated risk factors: pelvic inflammatory disease (PID), sexually transmitted diseases (STDs), intrauterine devices (IUDs), and abortion. To address this problem, the World Health Organization conducted a multinational case-control study between 1978 and 1980 of factors associated with ectopic pregnancy in 12 centers, 8 in developing countries and 4 in developed countries. Results suggest that risk factors are similar in women from developing and developed countries. The only exceptions were increased risks of ectopic pregnancy associated with spontaneous abortion or smoking in developing but not developed country centers. This may reflect misreporting of illegal induced abortion or postabortion complications, and behavioral differences between smoking and nonsmoking women in developing countries. All methods of contraception prevent pregnancy and so provide protection against ectopic pregnancy. This protective effect is least with the IUD, however, and accidental conceptions during IUD use or after sterilization carry an increased risk of ectopic pregnancy. With the IUD, this probably reflects both differential protection against intrauterine and extrauterine pregnancy and an increased risk of IUD-related PID resulting in tubal damage. The risk of ectopic pregnancy is also increased in women with a previous history of PID or a prior pregnancy. However, cesarean section was found to reduce the risk of ectopic gestations in all comparison groups.
Populi. 1983; 10(1):78-81.The World Health Organization's (WHO) aim is to achieve a level of health that will allow all the world's citizens to lead a socially and economically productive life by the year 2000. Peter D. O'Neill's book, "Health Crisis 2000," is based on WHO's European regional strategy for attaining "health for all" by the year 2000. Its goal is to enable a large audience to participate in a dialogue on the real issues. An analysis of trends in health and disease, made over the past 3 years by representatives of the medical profession, has produced ominous signs that current health policies have set a dangerous course. If "health for all" is to be realized by the year 2000, it will be necessary to implement a new strategy with 3 inseparable themes, i.e., health as a way of life, the prevention of ill health, and community care for all. While the book analyzes the 1st stage of work which the WHO European Region has drawn up for itself, it interprets the official strategy document and offers ample detail to draw ministers, parliamentarians, industrialists, and the media into the debate. Fakhruddin Iqbal reports that a recent study suggests that the Bangladesh family planning program neglected to consider age old social and cultural values. The study identifies 2 distinct cultural values that present obstacles to the program: the traditional preferences for age old treatment as opposed to modern medical practices and the persistent tradition of relegating women to the lowest rung of mass education; and the traditional family size perceptions of the people. Andrew Hamilton writes that the Jamaica Family Planning Association has employed 7 people to spread knowledge of family life education and family planning among youth. These 18-23 year old youth associates are part of a major national drive to keep Jamaica's population below 3 million by the year 2000. About traditional midwives Jan Steele writes that they deliver between 60-80% of babies in the developing world each year and provide support and care in environments commonly shunned by the medical profession. The IPS reports that according to the 1980 census the population of Brazil is 120 million. If the current demographic trends continue, the population will double by 2014. With the present unemployment level, there will be 41.5 million people underemployed and 15 million unemployed in 2014. Meena Panday writes that Nepal cannot seem to get its population program going. The Population Council reports that no evidence exists as yet that use of the copper bearing or nonmedicated IUD increases the risk of ectopic pregnancy.
IPPF Medical Bulletin. 1981 Dec; 15(6):1-3.These policy statements and guidelines from the International Planned Parenthood Federation's (IPPF) International Medical Advisory Panel (IMAP) concern IUDs. The following contraindications to IUD use are recognized: 1) pelvic inflaminatory disease, 2) known or suspected pregnancy, 3) history of previous ectopic pregnancy, 4) gynecological bleeding disorders, 5) suspected malignancy of the genital tract, 6) congenital uterine abnormalities or fibroids distorting the cavity, and 7) anemia, blood coagulation, severe cervical stenosis, copper allergy, Wilson's disease, and others. Generalities regarding appropriate IUDs are: 1) non-medicated devices (e.g. Lippes Loop) are studied for women who may not return for regular check-ups, 2) smaller medicated devices usually cause less menstrual blood loss than the non-medicated devices, 3) smaller devices are better for a smaller uterus and larger devices for the larger uterus, and 4) when a smaller device is expelled it is advisable to try a larger one and vice versa. Dalkon Shields should not be used by the IPPF system and all women using them should have the device removed. Correct insertion of IUDs is important and should be done by properly trained personnel. The timing of insertion is best during the menstrual period. Withdrawal of the applicator while leaving the device in place is the recommended insertion technique. Sterilization of IUDs should follow instructions on bulk-packaged IUDs. Complications include perforation, bleeding and pain, infection, and ectopic pregnancy. IUD removal should be done during menstruation. Good clinical management and follow-up care are recommended.
British Medical Journal. 1978 Mar 25; 1(6115):785-6.The steering committee of the Task Force on Intrauterine Devices for Fertility Regulation of the World Health Organization's Special Program of Research, Development, and Research Training in Human Reproduction has cited the following reservations regarding the hypothesized link between IUD use and ectopic pregnancy: 1) while available data suggest a real increase in the risk of ectopic pregnancy for IUD users, the magnitude of this risk cannot be quantitated in the absence of adequate comparative studies with nonusers; 2) the presentation of ectopic pregnancy rates as a percentage of total pregnancies may be affected by the conception-dependent reduction in intrauterine pregnancy rates; thus, ectopic pregnancy rates should be expressed as a life table rate/100 woman-years; 3) the risk factors predisposing to ectopic pregnancy vary between population and users of different methods, introducing bias unless this variability is considered in the study design; 4) failure to state the criteria for the diagnosis of ectopic pregnancy may have led to an overestimation of its incidence. Decidual reaction and/or blood in the Fallopian tubes are not sufficient diagnostic indicators; fetal parts (identified grossly or microscopically) and/or trophoblast must be identified; and 5) the limited data available and lack of comparability between studies do not permit the conclusion that Progestasert IUD users are at a higher risk of ectopic pregnancy, as has been suggested in recent reviews.