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In: WHO updates medical eligibility criteria for contraceptives, by Ward Rinehart. Baltimore, Maryland, Johns Hopkins Bloomberg School of Public Health, Center for Communication Programs, Information and Knowledge for Optimal Health Project [INFO], 2004 Aug. 2-4. (INFO Reports No. 1; USAID Grant No. GPH-A-00-02-00003-00)The 2003 Expert Working Group made several changes to the MEC to indicate that women often can safely use IUDs in conditions related to HIV and other sexually transmitted infections (STIs). Taken together, these changes should help reduce some providers’ concerns about offering IUDs in areas where HIV infection and other STIs are common. At the meeting the WHO Expert Working Group concluded that a woman generally can start using an IUD, if she wishes, even if she has AIDS—provided she is receiving ARV therapy and is clinically well—or if she has HIV infection or she is at high risk of HIV infection. The Expert Working Group changed these conditions from category 3 to category 2 for starting IUD use. According to the bulk of research considered at the WHO meeting, IUD use does not increase a woman’s chances of acquiring HIV infection. Women generally can keep their IUDs if they become infected with HIV or develop AIDS while using IUDs (category 2), although IUD users with AIDS should be carefully monitored for pelvic infection. Limited evidence shows that complications of IUD use are no more common among IUD users infected with HIV than among IUD users who are not infected with HIV. Also, IUD use does not increase HIV transmission to sexual partners. (excerpt)
Contraception. 1973 Jul; 8(1):67-73.The World Health Organization (WHO) Program of Research in Human Reproduction that began in 1972 deals with the development of a variety of safe, acceptable, and effective methods for the regulation of human fertility. Research has concentrated on areas where international collaboration would be most likely to accelerate the development of new methods. The program is clinically oriented and emphasizes meeting the objectives in the shortest possible time. Collaborative task force research was started in the following fields: 1) methods to interfere with the transport and/or survival of the ovum; 2) methods to prevent the implantation of the fertilized ovum in the uterus; 3) contraceptive methods for men that affect the fertilizing capacity of sperm by interfering with their maturation and survival without affecting sexual competence; and 4) methods to regulate sperm migration and survival in the human female.
Directory of hormonal contraceptives 1996. 3rd ed. Repertoire des contraceptifs hormonaux 1996. 3e edition. Guia de anticonceptivos hormonales 1996. 3a edicion.
London, England, International Planned Parenthood Federation [IPPF], 1996. 102 p. (IPPF Medical Publications)The "Directory of Hormonal Contraceptives" lists the composition and manufacturer of all such methods available in the major world countries. By coding all products with the same composition or formula, despite different brand names, the directory enables family planning providers to advise clients as to whether an identical formulation is available in other countries to which they might be relocating. The first and second editions of this directory were very useful to family planning associations, individual physicians, and international organizations. Since publication of the second edition in 1992, many new hormonal products have become available and others have been discontinued. This third edition expands the categories of hormonal contraceptives from the original five to eight: combined pills, phasic pills, progestogen-only pills, progestogen injectables, combined injectables, implants, hormonal IUDs, and emergency contraception. A further change is inclusion of some countries with populations under 100,000 that are members or associate members of IPPF. Finally, products containing more than 50 mcg of estrogen are no longer included since this dose is seldom used.
FAMILY PLANNING WORLD. 1992 Jan-Feb; 2(1):31.Currently there are only 2 IUDs available in the US: the TCu380A, known to practitioners as the Copper T380A and commercially as Paragard, holds the largest share of the market. This IUD is a Copper bearing variety that has a recently doubled life span of 8 years. Its annual cost is less than $40, masking it the least expensive form of contraception available. The other IUD is called the Progestasert, or the Progesterone T to practitioners, is a T shaped IUD that holds a years supply of Progesterone. It must be removed annually to be refilled. Practitioners have used this to its advantage by scheduling annual gynecological exams to be performed along with the refill. Both cost about $300 with the Progestasert having the additional annual cost of refill. GynoPharma has developed a new IUD that is currently part of the largest IUD safety study ever conducted. The WHO is conducting a study that involves a sample of 6000 women. The device is called Flexigard 330 and the company plans to apply for approval with the FDA before then end of 1992.
Lancet. 1992 Mar 28; 339(8796):783-4.It is difficult to determine if the IUD increases the risk of pelvic inflammatory disease (PID) because simple clinical features are not consistently predictive and can have low specificity and sensitivity. The C-reactive protein and the erythrocyte sedimentation rate tests help with PID diagnosis, but only a laparoscopy can determine tubal involvement. In 1970, WHO's Cooperative Statistical Programme found 2-year combined PID rates to range from 3.8 to 5.2/100 women with an IUD. Then WHO and various US organizations agreed IUD use did not necessarily cause PID. During the 1970s, however, a large rise in sexually transmitted diseases (STDs), especially chlamydia and gonorrhea, occurred and were associated with PID incidence. Many believed the growing rate of PID was attributable to the increasing use of IUDs. Many studies were biased because of overdiagnosis of PID. A 1990 review of 28 articles revealed that the overall PID rate was 1.49/100 woman years (lower than what many believed earlier). Some researchers used multicountry data on 22, 908 IUD insertions from WHO's data base for IUD studies to determine PID risk in IUD users. This risk was somewhat high during the 1st 20 days postinsertion which may be related to insertion, but PID rates in IUD users corresponded with those from the general population. PID rates did increase with age, however, and they did vary with geographical area. In addition, rates were 62% lower in women whose IUD was inserted after 1980. The PID rate was associated with background risk of STDs. These results and those of other studies suggest that health staff must adequately assess all patients before fitting the IUD and insert it only under strict aseptic conditions. IUDs that release copper and levonorgestrel pose a lower risk of PID than nonmedicated IUDs.
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.
In: Zatuchni GI, Goldsmith A, Shelton JD, Sciarra JJ, ed. Long-acting contraceptive delivery systems. Philadelphia, Pa., Harper and Row, 1984. 621-7. (PARFR Series on Fertility Regulation)Progestasert (Alza Corporation, Palo Alto, California) achieves relatively high rates of contraceptive effectiveness through the release of a sex hormone--progesterone. Currently, it is recommended that Progestaserts be replaces every 12 months and most copper-bearing IUDs, every 3 years. To improve on Progestasert's 1-year replacement interval, Alza Corporation modified the Progestasert by increasing the amount of pregesterone contained in the IUD (from 38 to 52 mg) without changing the average daily release of 65mg. This long-acting progestasert, called the Intrauterine Progesterone Contraceptive System (IPCS), was designed to have a useful life of 3 years before replacement was required. The IPCS is identical in appearance to the Progestasert, and its contraceptive action in the same as that of the Progestasert. The effectiveness of either is through the effects of an intrauterine foreign body and through the effects of the progesterone on the encometrium. The IPCS system was designed to provide maximum contraceptive protection over a 3-year period and to reduce IUD-related bleeding, pain, and expulsion problems. Results from Alza monitored trials of the IPCS in the US and Mexico indicate that the cumulative life-table pregnancy rate increased from 3.6/100 women after 25 to 30 months of use to 10.6/100 women after 30 to 36 months of use. Laboratory evaluations of removed IPCS devices indicates that after 30 months of IPCS use the release rate of progesterone may not be adequate to prevent pregnancy effectively. The World Health Organization (WHO) evaluated the IPCS in 2 multiclinic studies. Postinsertion complications and complaints for the IPCS and T Cu-200 are shown. The include cervical perforation, ectopic pregnancy, pelvic inflammatory disease, dysmenorrhea, bleeding, spotting, and pelvic pain. The IPCS seemingly offers no particular advantages for use in developing countries.
CONTRACEPTION. 1980 Jul; 22(1):97-102.A letter to the editor of the journal, Contraception, concerns an article previously published in that journal entitled "WHO study of the Progesterone IUD," and indicts that article as having ignored standards for scientific reporting of prospective trials of contraceptives. The authors of the complaining letter have attempted to reach the authors of the progsterone IUD paper, but have received no response to their questions; in this article, only a corrigendum from WHO disavowing any knowledge or authorization of the disputed paper constitutes the reply. Objections to the IUD study, which had been published in volume 19, number 6, June 1979, p. 575-589, include discrepancies with study dates, incompleteness of data, improper statistical conclusions of significance, errors in menstruation data, problems with computation of medians, and improper conclusions from existing data. The complainants conclude, "it appears that the contradictions and inaccuracies in the report, as well as the substantial incompleteness of the data being reported, prevent this report from being a scientific document of the material under study."
In: Mishell, D.R., Jr., and Martinez-Manautou, J., eds. Clinical experience with the progesterone uterine therapeutic system. (Proceedings of the Acapulco Workshop, Acapulco, Mexico, October 15-16, 1976.) Princeton, New Jersey, Excerpta Medica, 1978. p. 13-17There were 7323 first insertions, and 4177 subsequent insertions of the Progestasert intrauterine progesterone contraceptive (IPCS) in women all over the world. To obtain a diversity of testing situations private and public clinics were employed to evaluate the contraceptive efficiency and acceptability of the IPCS. 75% of patients were parous, and average exposure was 10 months. Portions of the study were monitored by WHO and by international and indigenous pharmaceutical companies. Results from the study suggest that consistency in pregnancy rate and in expulsion rates have been established. Removals are more likely to be cultural than physiological in nature. Up to now there are no indications that unforeseen complications due to the IPCS might be occurring.
In: Mishell, D.R., Jr., and Martinez-Manautou, J., eds. Clinical experience with the progesterone uterine therapeutic system. (Proceedings of the Acapulco Workshop, Acapulco, Mexico, October 15-16, 1976) Princeton, New Jersey, Excerpta Medica, 1978. p. 99-103In order to compare the efficacy and acceptability of the Progestasert progesterone-releasing IUD and the Gravigard Copper-7 device, 295 parous women randomly received the progesterone device (146) or the copper device (149). Follow-up examinations took place at 1, 3, 6, and 12 months postinsertion. It was found that event rates did not differ significantly between the progesterone (1569 women-months) and the copper (1558 woman-months) devices. Greater pain on insertion (23.3% versus 15.4%), less metrorrhagia (7.5% versus 13.4%), and higher continuation rates after 1 year of use (87.2% versus 84.6%) were associated with the progesterone device. A flow decrease of 27.2% and increase of more than 22.3% was associated with the Copper-7. Duration of menstruation was not significantly different between the 2 groups, but the progesterone IUD users had more days of "spotting." In both groups, duration of menstruation increased by the end of the study year for a large number of women. This was significant only in Copper-7 users.