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Intrauterine Contraception: Pearls From the Cochrane Library

David A. Grimes, MD

For many years, few health care professionals or their patients would consider the use of intrauterine contraception. However, a new generation of intrauterine devices has quietly been accruing positive data and making major inroads around the world, including the United States.

Intrauterine contraception is enjoying a renaissance in the United States. Much of this new popularity has been driven by high-quality research. Indeed, the cloud of suspicion that once hovered over intrauterine devices (IUDs) has largely been lifted. Specifically, it now appears that some alleged risks (eg, pelvic inflammatory disease [PID], infertility) were attributable to bias, not biology.1

Randomized controlled trials (RCTs) provide the best evidence on which to base clinical decisions. The Cochrane Collaboration, an international consortium of volunteers, was established to gather data from all RCTs that relate to important clinical topics, including IUD use. The trials are then critiqued, summarized in a standard format, and published in the Cochrane Database of Systematic Reviews (also known as the Cochrane Library). Although abstracts of all Cochrane reviews are available gratis at PubMed (www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed), a subscription is required to read the full text. Because few practitioners outside the academic community have access to the full Cochrane Library, this article highlights some of the emerging data on IUDs (Table).2

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TABLE. Intrauterine Contraception: Pearls From the Cochrane Library

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COPPER VERSUS HORMONAL

Both the copper T380A and levonorgestrel-releasing intrauterine system (LNG-IUS) have similarly high efficacy. Of the copper-bearing IUDs that have been used around the world, the copper T380A (which is available in the United States) has been found to be the most effective. Its efficacy rivals that of interval tubal sterilization, and a recent report documented contraceptive protection with the copper T380A lasting 20 years.3,4 The implications are striking: a woman 25 years of age might have this IUD inserted and never need to think about contraception again. Spontaneous fertility is negligible by the mid-40s, and a woman could continue using the IUD until menopause.

The LNG-IUS is similarly effective, and has been judged to have efficacy comparable to that of IUDs containing more than 250 mm2 of copper. However, the LNG-IUS has been associated with a higher rate of amenorrhea and spontaneous expulsion than IUDs containing more than 250 mm2 copper.2 In contrast, discontinuations for pain and bleeding were more common with the copper IUDs than with the LNG-IUS.2 In short, both IUDs available in the United States have top-tier effectiveness, but differ with regard to their impact on uterine bleeding and duration of use.5

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POSTPREGNANCY INSERTION

Insertion of an IUD immediately after childbirth or abortion is safe and effective. In countries from China to Egypt to Honduras, clinicians commonly insert an IUD promptly after the placenta is delivered. An IUD can also be placed in the uterus immediately after cesarean delivery. Although spontaneous expulsions appear to be more likely than with insertion remote from pregnancy, no studies have directly compared immediate postpartum with later insertion. Offsetting the possibility of higher expulsion rates are high motivation, comfort, and convenience of insertion right after childbirth. A recent study of immediate ultrasonographically-guided postpartum LNG-IUS insertion found an expulsion rate of 11% at 10 weeks’ follow-up.6 Conversely, 89% of subjects were continuing with this top-tier method.

The rate of immediate postabortal insertions is increasing, as well. Only 1 trial has compared immediate postabortal insertion with scheduled return in 3 to 5 weeks for insertion. Although the risk of spontaneous expulsion was 6-fold higher with immediate insertion, 42% of the women randomized to return for later insertion failed to keep their appointments. It is possible that those lost to follow-up were using an alternative contraceptive method, but many of them likely chose to use no contraception at all—and thus were at risk for unintended pregnancy. In this setting, the advantages of high motivation, convenience, and comfort during insertion must be weighed against the higher risk of expulsion. Earlier concerns about increased risks of perforation and infection with immediate postabortal insertion have been refuted.2

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PROPHYLACTIC ANTIBIOTICS

Prophylactic antibiotics are clearly indicated for suction curettage abortion.7 Therefore, some postulated that by analogy, antibiotic coverage during IUD insertion might protect against infection as well. Several RCTs have examined this question, and prophylaxis is usually not warranted. Prophylaxis should be considered only in women with a high prevalence of sexually transmitted infections. In the largest US trial, which gave azithromycin or a placebo to about 1,000 women in each group, PID was rare with or without antibiotics.8

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MANAGEMENT OF BLEEDING AND PAIN

Bleeding and pain are the leading reasons for discontinuation of IUD use, so that managing these symptoms is an important clinical concern. Many trials have explored various treatments. The NSAIDs constitute the first line of treatment, as they not only decrease cramping but also reduce bleeding.2

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PROPHYLACTIC NSAIDs

Given the usefulness of NSAIDs in treating pain and bleeding after IUD insertion, investigators have studied their potential prophylactic benefit in terms of promoting continuation—especially just prior to the time of insertion and during the next 6 menses. A large trial from Chile with ibuprofen, 400 mg, found no benefit in continuation rates.9 Some have speculated that a larger dose, such as 800 mg, might have yielded better results.2

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EMERGENCY CONTRACEPTION

Insertion of a copper-bearing IUD after unprotected coitus confers powerful protection against pregnancy, whereas the LNG-IUS should not be used for this purpose. One RCT compared insertion of a copper T200 (200 women) with expectant management after unprotected sex (100 women).2 As expected, the risk of pregnancy after IUD insertion was 10% of that in the watchful-waiting group.

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OFF-LABEL INDICATIONS

The FDA endorses off-label use of drugs, provided scientific evidence supports that use. Because of several important, well-established noncontraceptive benefits of the LNG-IUS, considerable off-label use is occurring in the United States.

The ability to deliver high doses of progestin to the endometrium has opened new vistas in gynecologic therapy. Menorrhagia is a common problem. The RCTs have found the LNG-IUS superior to oral progestins in reducing excessive uterine bleeding.2 Endometrial ablation techniques reduce bleeding better than the LNG-IUS, but patient satisfaction with both therapies was similar.2 Moreover, two trials have found insertion of an LNG-IUS to be acceptable as both a short- and long-term alternative to hysterectomy in women with uterine bleeding that is not reduced by medical treatment. Endometriosis is another widespread and often disabling problem. Two recent RCTs have examined the use of the LNG-IUS for treating pain associated with endometriosis. One found that insertion of the LNG-IUS was more effective than expectant management after the endometriosis had been treated via laparoscopy.2 Another trial compared the LNG-IUS with leuprolide acetate after laparoscopic treatment of endometriosis. Both were equally effective in relieving pain, but the leuprolide was associated with less uterine bleeding.2 On the other hand, 1 month of leuprolide acetate therapy cost approximately the same as the LNG-IUS, which is approved for 5 years of use.

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CONCLUSION

Intrauterine devices can be used in more women and in more settings than were ever envisioned in decades past. Package labeling is beginning to reflect this liberalization of IUD use. Both the copper T380A and LNG-IUS provide contraception similar to that of surgical sterilization, but are less expensive, more convenient, and immediately reversible. The IUDs are associated with alterations in bleeding patterns, however, so women should be advised about what to expect.

Insertion can be performed right after delivery of the placenta, or after abortion in the first and second trimesters. The disadvantage of an increased risk of expulsion should be weighed against the greater convenience of insertion in this setting. Prophylactic use of antibiotics or NSAIDs is not advised for insertion, but the latter are effective for treating postinsertion pain and bleeding. Emergency contraception with the copper-bearing IUD is effective and provides long-lasting protection, unlike emergency hormonal contraception. The LNG-IUS can be used to treat heavy uterine bleeding and the pain associated with endometriosis. Other potential uses, including treatment of endometrial hyperplasia, are being explored, as well.

In the 1970s and 1980s, the IUD almost disappeared from the United States—the victim of bad epidemiology, bad press, and bad tort law.10 High-quality scientific investigation, including the RCTs summarized in the Cochrane Library, has ushered in a new era of intrauterine contraception. Internationally, the IUD is the most commonly used method of reversible contraception.11 Thanks to better science, the United States is now beginning to catch up with the rest of the world.

The author reports that he is a consultant to Bayer HealthCare Pharmaceuticals and Barr Pharmaceuticals, Inc.

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David A. Grimes, MD, is Clinical Professor, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill.

References

1. Grimes DA. Intrauterine device and upper-genital-tract infection. Lancet. 2000;356(9234):1013–1019.
2. Grimes DA, Lopez LM, Manion C, Schulz KF. Cochrane systematic reviews of IUD trials: lessons learned. Contraception. 2007;75(6 Suppl.):S55–S59.
3. Grimes DA, Mishell DR Jr. Intrauterine contraception as an alternative to interval tubal sterilization. Contraception. 2008;77(1):6–9.
4. Sivin I. Utility and drawbacks of continuous use of a copper T IUD for 20 years. Contraception. 2007;75 (6 Suppl.):S70–S75.
5. Steiner MJ, Dalebout S, Condon S, Dominik R, Trussell J. Understanding risk: a randomized controlled trial of communicating contraceptive effectiveness. Obstet Gynecol. 2003;102(4):709–717.
6. Hayes JL, Cwiak C, Goedken P, Zieman M. A pilot clinical trial of ultrasound-guided postplacental insertion of a levonorgestrel intrauterine device. Contraception. 2007;76(4): 292–296.
7. Sawaya GF, Grady D, Kerlikowske K, Grimes DA. Antibiotics at the time of induced abortion: the case for universal prophylaxis based on a meta-analysis. Obstet Gynecol. 1996;87(5 Pt 2):884–890.
8. Walsh T, Grimes D, Frezieres R, et al. Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices. IUD Study Group. Lancet. 1998; 351(9108):1005–1008.
9. Hubacher D, Reyes V, Lillo S, et al. Preventing copper intrauterine device removals due to side effects among first-time users: randomized trial to study the effect of prophylactic ibuprofen. Hum Reprod. 2006;21(6):1467–1472.
10. Boonstra H, Duran V, Northington Gamble V, Blumenthal P, Dominguez L, Pies C. The “boom and bust phenomenon”: the hopes, dreams, and broken promises of the contraceptive revolution. Contraception. 2000;61(1):9–25.
11. d’Arcangues C. Worldwide use of intrauterine devices for contraception. Contraception. 2007;75(6 Suppl.):S2–S7.

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