How IUDs Prevent PregnancyResearch has shed new light on how IUDs prevent pregnancy. Studies suggest that IUDs prevent sperm from fertilizing ova (437, 501, 544). Current evidence does not support the common belief that the IUD usually works by preventing implantation (501). Researchers in Chile recovered ova from 56 women using various IUDs and 115 women not using contraception. The researchers were significantly less likely to recover ova from the fallopian tubes of the IUD users, especially those using copper IUDs, than from the other women. Fourteen of the IUD users and 20 of the nonusers had recently had sexual intercourse around the time of ovulation. None of the ova recovered from these IUD users showed clear signs of fertilization and normal embryonic development. In contrast, half of the ova recovered from the nonusers did (478). These results provide the clearest evidence to date that IUDs work chiefly by preventing fertilization. Studies using assays for human chorionic gonadotropin (hCG), a hormone secreted by cells surrounding the fertilized ovum, also suggest that IUDs generally prevent fertilization (317, 416, 427). These assays can detect fertilization within 7 to 10 days, well before implantation of a fertilized ovum is complete (106, 198, 437). Two studies of women using mainly copper IUDs have found hCG assays indicating fertilization in less than one percent of menstrual cycles (317, 427). Copper IUDs affect ova and sperm in various ways. They stimulate a pronounced inflammatory reaction, or foreign-body response, in the uterus. The concentration of various types of white blood cells, prostaglandins, and enzymes in uterine and tubal fluids increases markedly (174, 243, 264, 312, 322, 437), especially with copper IUDs (235). These changes may interfere with transport of sperm in the genital tract and may damage sperm and ova so that fertilization is impossible (260, 437). In most studies fewer sperm are found in the fallopian tubes, where fertilization is thought to take place, in IUD users than in nonusers (12, 193, 312, 386). Various types of white blood cells probably consume many sperm in the uterus (312). Other sperm maybe damaged so that they cannot move into the fallopian tubes (260). Thus, while the precise mechanism of action of copper IUDs is still not certain, most likely the primary action is altering the function or survival of sperm and ova before they can meet (501). In contrast, the LNG-20 IUD, although it also prevents sperm and ova from joining, has a primarily hormonal mode of action, probably working chiefly by thickening cervical mucus so that sperm cannot pass through it (610). |
Lifespan of Copper IUDsClinical trials show that all of the widely used copper IUDs are effective for at least five years and many are effective longer (21, 225, 226, 307, 380, 383, 405, 451, 453, 491, 547, 549, 566). The only IUD currently approved for more than five years, however, is the TCu-380A, which in 1993 was approved by the United States Food and Drug Administration for 10 years of use (620). Regulatory approvals are generally based on effectiveness demonstrated in clinical trials but must await the sponsor's application and often lag behind the latest research findings. Long-term randomized clinical trials of copper IUDs report low cumulative pregnancy rates for the second-generation copper IUD—after 10 years, 2.1 per 100 women with the TCu-380A and 5.7 with the TCu-220C, and after five years, 3.4 to 10.0 in three trials with the Nova T (226, 307, 566, 573, 625) (see Table 1).In WHO comparative trials the TCu-380A was significantly more effective than the TCu-220C (625), and the TCu-220C was significantly more effective than the Nova T (307). In a WHO 3-year comparative trial the pregnancy rate for the MLCu-375 was low, at 2.9 pregnancies per 100 women, but this IUD was significantly less effective than the TCu-380A, at a rate of 1.6 (648) (see Table 1). By comparison, nonrandomized trials of the TCu-200, a first-generation copper IUD with less copper, reported generally higher 5-year pregnancy rates—from 7 to 12 per 100 women (331, 451, 453). Annual pregnancy rates do not increase over time for long-term IUD users, and they may decrease. For example, in WHO clinical trials annual pregnancy rates for the TCu-220C fell from 1.3 during the first two years to 0.5 during the third through fifth years to 0.4 during the sixth through eighth years. Over the same period annual pregnancy rates for the TCu-380A fell from 0.3 to 0.1 (545). Over 10 years of use pregnancy rates averaged less than 0.5 per 100 women per year for the TCu-380A and less than 1.0 for the TCu-220C from the second year of use (625). This study has continued through 12 years of use, and data covering the last two years will be published in 1996. The fall in annual pregnancy rates after the first two years of IUD use does not appear to reflect a cumulative effect of the IUD. Rather, it occurs largely because the women using IUDs for long periods tend to be older and thus less fertile than short-term users (437). Also, women whose IUDs are improperly inserted, are expelled without their noticing, or perforate the uterus are most likely to become pregnant early in the study. Declining annual pregnancy rates over long periods are seen also in women using inert devices such as the Lippes Loop (385). As researchers study women using second-generation copper IUDs for increasing lengths of time, the approved lifespans of some copper IUDs may be further extended. Less frequent replacement reduces the risks of pelvic inflammatory disease, perforation, and other complications that mainly occur at or soon after insertion. Also, less frequent insertions cost less and are more convenient. |
An Expert Group Answers Questions:Procedures for Providing IUDsTo develop a consensus in light of current scientific understanding, a group of experts recently answered important questions concerning procedures for providing various family planning methods including IUDs. The group was convened by the USAID Collaborating Agencies, private and nonprofit organizations working with support from the US Agency for International Development (USAID). The group, named the Technical Guidance Working Group, intends its answers as guidance for programs developing or revising their own procedural and service guidelines. In issuing its report, the group sought to address two problems—(1) inconsistencies or conflicts in existing procedural guidelines can cause confusion; and (2) guidelines that are out of date in light of scientific evidence often restrict access to contraceptive methods unnecessarily (634). Assessing the value of specific clinic procedures, the Working Group concluded that counseling, including discussion of increased bleeding, reasons to return, STD risk behavior, and condom use for STD protection; pelvic examination; and verbal STD screening are essential procedures. In contrast, a blood pressure test, breast examination, lab tests for STDs in women without symptoms, and cervical cancer screening may be appropriate for good preventive health care when indicated but are not required or not related to safe use of IUDs. Routine, mandatory lab tests such as cholesterol, glucose, and liver-function tests are irrelevant (634). Questions and answers from the Working Group include the following:
A: An IUD can be inserted immediately after delivery of the placenta or at the time of cesarian section and any time up to 48 hours after delivery. IUD insertion is not advisable between 48 hours and four weeks postpartum. As early as four weeks postpartum copper IUDs can be inserted because their withdrawal insertion technique minimizes risk of uterine perforation; other types of IUDs can be inserted as early as six weeks postpartum (233, 498, 535). Breastfeeding women can safely use IUDs (508).
Other Questions and Answers
|
Infection Prevention for IUD Insertion and RemovalCareful infection-prevention practices are essential during IUD insertion and removal. IUDs should not be inserted or removed if infection-prevention procedures cannot be followed (634). For insertion, infection-prevention practices involve four steps: (1) Washing hands and then putting on gloves. Washing hands may be the single most important infection-prevention measure (614). Either new disposable gloves or gloves that have been high-level disinfected (HLD) by boiling or steaming for 20 minutes (655, 656) should be used for each new client. Gloves need not be sterile. (2) Cleaning the cervix and vagina. After the speculum is inserted, an effective antiseptic solution should be liberally applied first to the cervix (especially the os) two or three times and then to the vagina. A water-based antiseptic should be used, such as an iodophor or chlorhexidine gluconate. Alcohol should not be used because it burns and it dries out and irritates mucous membranes, making them more susceptible to infection. When using an iodophor, such as povidone iodine (e.g., Betadine®), the provider should wait one or two minutes for these antiseptics to become effective before proceeding (614). (3) Using the no touch insertion technique. For the TCu-380A and other IUDs that come with inserters in sterile packaging, the IUD is loaded into the inserter while both are still in the package (591). During sounding and insertion, the provider avoids touching the vaginal wall or speculum blades, which would contaminate the HDL (or sterile) uterine sound or loaded IUD. The provider passes the HDL sound and the sterile IUD, loaded in the inserter tube, each only once through the cervical canal (614). This no touch technique is easy to learn and use. (4) After the insertion procedure, washing hands again and then processing instruments for the next use (283, 635). Similar steps—handwashing before and after, applying disinfectant to the cervix, and proper processing of instruments—also apply to IUD removal. Processing Instruments for ReuseProcessing instruments for reuse (step 4) consists of three steps in itself—(a) decontamination, (b) cleaning, and (c) either high-level disinfection or sterilization.
High-level disinfection, if properly carried out, destroys most microorganisms including hepatitis B, herpes simplex type 2, human papilloma virus, and HIV, which causes AIDS (96, 435). Low-level disinfectants such as benzalkonium chloride (for example, Zephiran®) and antiseptic solutions (such as Savlon®, which is a mixture of cetrimide and chlorhexidene), as well as alcohols and iodine solutions, do not quickly kill viruses and some other microorganisms and should not be used (96, 283, 635). Sterilization—that is, destroying all microorganisms, including bacterial endospores—is desirable but not necessary with instruments used for IUD insertion and removal since the instruments touch only mucous membranes and do not come in contact with the blood stream (96, 191, 436). HLD or sterile instruments and loaded IUD inserters should be carefully handled so that they are not contaminated. Providers should touch them only with HLD or sterile gloves or instruments, and there is no need to touch the loaded IUD at all. HLD or sterile instruments can be stored dry for about a week in a HLD container with a tight-fitting lid (635). For more information and guidance about infection-prevention practices for IUD insertion and removal, see McIntosh, N., Kinzie, B., and Blouse, A., eds. IUD guidelines for family planning service providers: A problem-solving reference manual. Baltimore, Johns Hopkins Program for International Education in Reproductive Health (JHPIEGO), 1993 (614); Tietjen, L., Cronin, W., and McIntosh, N. Infection prevention for family planning service programs. Baltimore, JHPIEGO, 1992 (635). |
Clinical Signs of Genital InfectionsAn IUD should not be inserted in a woman with certain lower genital tract—infections particularly acute mucopurulent cervicitis (inflammation of the cervix with pus and mucus discharge), gonorrhea, and chlamydial infection (419, 458, 565). Also, an IUD should not be inserted in a woman likely to have pelvic inflammatory disease (126, 398, 419, 437, 565). All potential IUD users should be screened for the clinical signs and symptoms of these infections. Since gonorrhea and chlamydial infection are often asymptomatic in women, family planning providers also should ask a woman if her sexual partner has symptoms, although men also may show no symptoms. The common clinical signs and symptoms of genital infections include:
Signs and Symptoms in WomenLower genital tract infections:
Signs and Symptoms in MenGonorrhea, chlamydial or other infection:
|
Important Information About the TCu-380A IUDThis information can be copied and given to IUD users. Very effective, convenient, long-lasting, reversible.The TCu-380A IUD is one of the safest and most effective family planning methods. It can be used right after giving birth, during breastfeeding, and any other time. It can be taken out if you want to become pregnant.
Little to do once the IUD is in place.Your IUD works by itself. You do not need to do anything to keep it working.You may have cramps for the first few days, vaginal discharge or spotting for a few weeks, and somewhat heavier menstrual periods. You can check the IUD strings to be sure the IUD is still in place. Always wash your hands first. Then, with your finger, you should be able to feel the IUD string in the vagina. Check once a week for the first month. Then check after each menstrual period. If the string feels longer, shorter, or missing, or if you feel something hard, come to the clinic. The IUD may be out of place.
The IUD is safe for most women, but some should not use the IUD.Pregnant women should not have an IUD put in.Women who have a sexually transmitted disease (STD) or who think they might get an STD should not use IUDs. People can get STDs if they have more than one sexual partner or their sexual partner has other partners. If you already have an IUD and now might get a sexually transmitted disease, you should use condoms along with your IUD. Also, think about switching to a different family planning method. The IUD does not prevent sexually transmitted diseases including AIDS.
Please come back......For a routine checkup after your next menstrual period, 3 to 6 weeks after the IUD is put in. The IUD is most likely to come out in the first month of use....If you have very heavy bleeding or bad pain in the belly, especially with fever, or if you might get or have an STD, if you might be pregnant, or if the IUD might be out of place. ...Any time you have any questions, problems, or concerns. Your family planning provider is always happy to help. ...Any time you want the IUD taken out, for any reason.
You can keep your IUD for at least 10 years.Your TCu-380A IUD may become less effective after 10 years. It needs to be taken out in __________ __________ [month, year]. A trained family planning provider can take out your IUD. You can get a new IUD at the same time if you want.Source: Hatcher et al. 1996 (597) |
The GATHER Approach to Counseling About IUDsThere are six steps to family planning counseling (see Population Reports, Counseling Guide, J-36, December 1987). The provider can remember the steps using the English word "GATHER." G—Greet clients. The provider greets clients politely and gives them full attention. A—Ask clients about themselves. The provider asks clients about their family planning needs and obtains information that will help the provider advise and inform each client individually. T—Tell clients about family planning methods. The provider lists the available family planning methods and clearly describes those that interest the client—how they work, advantages and disadvantages, and possible side effects. Even clients who immediately express a preference for the IUD or some other method should know of other available methods for future reference and so they can inform friends and family members. H—Help clients choose a method. Some women may have already decided that they want an IUD. Others may want advice and guidance from the provider. In either case the provider helps the woman decide on a safe method that suits her needs and plans. If the method is not appropriate, the provider explains why and helps the client select another method. If there are reasons that another method would be preferable, the provider and client compare the risks and benefits of the IUD and of other contraceptive methods and consider the risks of an unintended pregnancy. The final decision to use an IUD—or any other method—must be an informed choice made by the client. If possible, involving the husband in counseling is a good idea. In an African study husbands' wishes accounted for many IUD removals after postpartum insertion (592). E—Explain how to use the IUD. Once a woman decides to use an IUD, the provider explains:
It is helpful to give clients printed material to take home, particularly a card with the name and picture of the IUD, noting the date of insertion and time for removal (398). (Printed ~materials can help providers, too. During counseling and screening, flip charts, wall charts, cue cards, and checklists help providers maintain accuracy and remember what to cover, and they help clients understand.) The client should be told if and how she will be notified when it is time for the IUD to be replaced. The family planning program should keep records for each IUD user showing the type of IUD and when it was inserted. These records should be used to answer questions from women who have forgotten when to have their IUDs replaced and to follow up users when the time for replacement approaches. R—Return for follow-up. When a woman has an IUD inserted, she and the provider should plan for a follow-up visit three to six weeks later, after her next menses. While no further scheduled follow-up visits are required for the safe use of the IUD, the woman should be strongly encouraged to return whenever she has questions or problems or if she wants the IUD removed (319, 398). Also, she should return as soon as possible if she notices any warning signs (see sidebar, Important Information About the TCu-380A IUD). The provider should be sure that the woman knows both when and where to seek medical care (164). At the follow-up visit three to six weeks after IUD insertion, the provider should ask about any menstrual problems, pain, or expulsion. A pelvic examination can be performed not only to check for the IUD strings but also to look for signs of pelvic infection, which is most likely to occur within the first weeks after insertion (see Chapter 5, Infection) (7, 82, 436). The provider also should reassure the client about any common side effects, remind her of the warning signs of IUD complications, and address any other concerns or questions she might have. Research has demonstrated that there is no reason to require IUD users to return to the clinic repeatedly at regular intervals when they are having no problems. In a study of more than 11,700 routine follow-up clinic visits by IUD users, only 72 visits detected a need for IUD removal that the clients themselves would not have recognized (601). Avoiding unnecessary routine visits saves resources to provide important services to other clients. IUD users are likely to benefit more if they are made to feel welcome to return at any time that they have problems, questions, or concerns. To handle serious complications, programs should make arrangements with a referral medical center. The center should be staffed with surgeons and gynecologists and have facilities for diagnostic and surgical procedures (436). Health care providers should remove copper-bearing and hormonal IUDs when the IUD reaches the end of its approved lifespan if it has not been removed sooner at the woman's request or for medical reasons. A new IUD can be inserted immediately afterwards, without any waiting period, if a woman wants to continue using an IUD. If a woman is having no problems, the Lippes Loop and other nonmedicated IUDs do not need to be removed until menopause (7, 162). After menopause removal may be difficult because the uterus shrinks and narrows (179). Of course, removal should be available promptly whenever a woman requests it and whatever her reason. When a new IUD is being introduced, women using a different IUD may want to replace it with the new one. Because most IUD complications and pregnancies are most common just after insertion, changing IUDs unnecessarily should be discouraged. A woman should be encouraged to wait until her current IUD reaches the end of its approved lifespan or until it must be removed for other reasons. |
WHO Scientific Group Updates Eligibility Guidelines for Copper IUDsA World Health Organization (WHO) scientific working group recently developed up-to-date recommended eligibility criteria for all major contraceptive methods including IUDs (565). The group based its recommendations on an assessment of research findings. To date, lists of eligibility criteria, or contraindications, in IUD training protocols have differed widely (574). The consensus reached by the WHO group of scientists from around the world should help resolve these conflicts. The WHO scientific group classified medical conditions into four categories. In situations where doctors and nurses are not available to assess specific cases, these four categories can be simplified into two categories—conditions in which the method is safe and effective, and conditions in which the method should not be used. These criteria refer to a client's characteristics or known preexisting medical conditions. For the most part, these characteristics or conditions can be detected by asking the client questions or, in the case of IUDs, making observations during the pelvic examination. Other physical examination or laboratory tests generally are not necessary. Eligibility criteria for starting use of a copper-bearing IUD, as categorized by the WHO scientific working group, are as follows:
Safe and Effective to Use Copper-Bearing IUDThese conditions do not restrict use of copper-bearing IUDs:
WHO Category 2: Advantages generally outweigh theoretical or proven disadvantages, and copper-bearing IUDs generally can be provided without restriction in these conditions:
Should Not Use Copper-Bearing IUD
WHO Category 4: Conditions that rule out use of copper-bearing IUDs:
|