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Training and reference guide for a screening checklist to initiate use of the copper IUD. Second edition.
Research Triangle Park, North Carolina, Family Health International [FHI], 2009. 79 p. (USAID Cooperative Agreement No. GPO-A-00-05-00022-00)This training and reference guide was developed for family planning service providers interested in using the Checklist for Screening Clients Who Want to Initiate Use of the Copper IUD, commonly referred to as the "IUD Checklist." Designed to serve as both a training and reference tool, the guide is composed of two parts: a training module and a collection of essential, up-to-date reference materials on the copper intrauterine device (IUD). This guide is part of a series to train on other checklists. The IUD Checklist was developed to assist service providers in screening clients who have already been counseled about contraceptive options and who have made an informed decision to use the copper IUD. This simple job aid is based on the technical guidance provided by the World Health Organization (WHO) in its Medical Eligibility Criteria for Contraceptive Use (2004, updated 2008). The checklist supports the application of these guidelines -- known as the WHO MEC -- into service delivery practice. (Excerpts)
Geneva, World Health Organization, 1966. (Technical Report Series NO. 332).The value and possible hazards of IUDs are discussed. Grafenberg developed a metal ring IUD in 1928. There was initial enthusiasm about the device, but it became discredited and interest was not revived in the method until 1959. Today, various shapes, sizes, and materials are employed in making IUD'S. No single cause or mechanism of action of an IUD has so far come to light. In sub-human primates the IUD causes accelerated passage of ova through the tube and the rest of the reproductive tract appears to be the major, but not necessarily the only, mechanism, of action. In ruminants, the contraceptive action of the IUD is exerted, at least in part, at the ovarian level. In rats, mice, rabbits, and ferrets, the main effect of the IUD is suppression of the implantation. It is concluded that the action of the IUDs in the human species is exerted before the stage of implantation. The most effective devices are associated with an incidence of 1.8 to 2.9 pregnancies per 100 insertions during the first year of use. The frequency of spontaneous expulsion ranges from about 5% to over 20% depending on the type of device. About one half of all expulsions occur in the first 3 months and comparatively few after the first year. The incidence of removal for medical reasons ranges from approximately 10% to 25% of first insertions during the first year. The method can be used successfully by almost 3 out of every 4 women who adopt it. Side effect and complications include bleeding and pain and less frequently pelvic inflammatory disease and perforation. The only absolute contraindications to the use of IUDs are: (1) active pelvic inflammatory disease, and (2) pregnancy, proven or suspected. Research needs are noted.
PEOPLE AND THE PLANET. 1993; 2(4):5.After years of hesitancy, due to financial and manufacturing problems, the Chinese Government has finally moved to replace the steel ring IUD with the Copper T. The steel ring, used by some 60 million women, has been pronounced unreliable by the WHO and is blamed for some 30% of the country's 10 million annual abortions. It will no longer be manufactured. China has received financial and technical assistance from the UNFPA to establish 2 factories to produce the Copper T 220 and next year it will expand this capacity, as well as starting production of the Copper T 380-A. The introduction of the newer IUD is likely to prevent the following events during the next 10 years: 55,600 pregnancies, 18,400 live births, 35,600 induced abortions, 16.300 maternal deaths. 365,000 infant deaths, and 28,800 child deaths. The cheaper IUD was used by more than 40% of Chinese women using modern contraception, making it the country's most common contraceptive method. (full text)
PID risk for IUD users highest in first 20 days after insertion; risk then falls sharply and remains low.
Family Planning Perspectives. 1992 Sep-Oct; 24(5):235-6.Researchers analyzed data on 22,908 women obtained from randomized WHO studies from 23 countries to determine whether the IUD increases the risk of pelvic inflammatory disease (PID). 35% of the women used the TCu220C IUD, 39% other copper releasing IUDs, 16% a hormonal IUD, and 9% the Lippes Loop. The overall PID incidence rate was 0.4% of all IUD insertions or 1.6 cases/1000 woman years. The incidence was greatest during the 1st 20 days after insertion (9.7 cases/1000 women years) and then declined to 1.4/1000 woman years. In fact, the risk of PID was >6 times greater within 20 days after insertion than it was >20 days after insertion. This high risk immediately after insertion was evident in every region where PID existed, at all insertion times, and in all age groups. The higher risk within the 20 days after insertion was attributed to contamination of the uterus during insertion. Women who had an IUD inserted after 1980 experienced PID 50% less often than those who had had it inserted earlier, e.g., the rate ratio for 1977-80 was 1.5 but was 0.5 for 1981-83 and 0.34 for 1984 and after. This may have been due to physicians being more aware of contraindications for IUD use, particularly past infection with sexually transmitted diseases )STDs). The rate ratio was higher in Africa (2.6) than it was in Europe (1) but lower in Asia (0.46) and in the Americas (0.39). None of the subjects in China experienced PID. Older women were at lower risk of PID than 15-24 year olds (0.44 for 25-29 year olds, 0.38 for 30-34 year olds, and 0.35 for =or> 35 year olds). The researchers believed the higher risk life styles of the younger group accounted for this difference. Risk of PID decreased with family size (2.5 for 0 children, 0.56 for 2 children, and 0.39 for at least 4 children). The risk of PID did not differ with IUD type. The researchers concluded that the major determinant of PID is exposure to an STD rather than type of IUD.
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.
NEW ZEALAND MEDICAL JOURNAL. 1987 Aug 12; 100(829):503.In 1987, the Minister of Health of New Zealand called for a committee to examine standards for IUDs, set guidelines for packaging information, consider reports of adverse reactions, and request information on IUD usage from users, physicians, and manufacturers. The media presented the committee's purpose and concerns in such a way, however, that coverage caused anxiety and uncertainty among women using IUDs. The family planning and medical communities needed to reassure those women with an IUD and who have had no problems of the IUD's safety. A 1987 WHO report could assist these communities because it attested to its effectiveness and safety for some women. For example, it referred to a Women's Health Study in the United States and WHO studies that showed that current IUD users are not at any higher risk of ectopic pregnancy than are those women who do not use any contraception. The report also stated that uterine perforation occurs <1/2000 insertions. In addition, it referred to evidence that fertility returns immediately after removing the IUD. The report concluded that the IUD is an important method of fertility regulation with high continuation rates and significant advantage in convenience of use. On the other hand, it also concluded that some women should never have an IUD, such as those who have invasive cancer of the cervix or uterus, a suspected pregnancy, or active pelvic infection. It further pointed out contraindications which included nulliparity, past ectopic pregnancy, anemia, heavy menstrual bleeding, previous pelvic inflammatory disease, an abnormally shaped uterus, etc. Women must always have the right to select from a range of contraceptives, including the IUD, and make an informed decision as to which method is best for her needs.
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.
[Unpublished] 1979. Presented at the International Symposium Medicated IUDs and Polymeric Delivery Systems, Amsterdam, Holland, 1979 June 27-30. 23 p.After almost 20 years of worldwide availability and use of IUDs, assessment of their future role for family planning remains difficult. There are differences concerning the success of IUDs in different programs, and there is also wide variation among individual women in the acceptability and utility of the IUD. Successful IUD use seems to depend upon a complex interplay of factors which include the technology of the IUD itself, biological variation among women, individual and cultural differences in tolerance of IUD caused side effects, and the nature and quality of the available medical care and follow-up services. The principal difficulties encountered in IUD use are discomfort and increased bleeding, spontaneous expulsions, increased frequency of uterine and pelvic infection, and pregnancy failures. In the early years of mass programs for family planning in developing countries the IUD was often emphasized. Inadequate data exists to obtain an accurate world picture of IUD usage and demographic impact at this time. IUDs are available in most countries through a number of channels, and figures on distribution and usage through sales and service programs are incomplete. The best measurement of prevalence of use of IUDs comes from special surveys selected in order to provide a representative sample of the nation's or an area's population. The usage of IUDs in China and India is reviewed. When fertility effects on acceptors are examined, the experience with the IUD seems to be favorable compared with other means of fertility control, but the programmatic impact of IUD use has not been so favorable. Many countries have either added additional means of fertility control or switched emphasis to other methods.
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.
Report on The First Meeting of The Inter-Governmental Coordinating Committee of Southeast Asia Regional Cooperation in Family and Population Planning, Djakarta, Indonesia, April 28-29, 1971.
Kuala Lumpur, Malaysia, IGCC, 1971. 49 p.This report is divided into 5 broad sections: 1) Opening Ceremony; 2) Working Sessions; 3) Text of Addresses, Statements, Documents and Press Release; and 4) Members of the Coordinating Committee, Observers, Interim Secretariat and Conference Staff. The Working Sessions include procedural arrangements, consideration of projects and programs agreed to at the first ministerial conference, presentation and consideration of new proposals for cooperation, date and venue of next meeting, adoption of meeting report and press release. Working papers are as follows: 1) Study Tours and Exchange of Family Planning Personnel in Southeast Asia; 2) Exchange of Experience in Training Courses in Southeast Asia; 3) Development and Maintenance of Inventories of Individuals and Institutions possessing Experience and Expertise in areas relevant to Population and Family Planning within Southeast Asia; 4) Circularization of Information, Education and Research Materials on Family Planning; 5) Standardization of Terminology; and 6) Research Projects on Thromboembolic Diseases.