Grand Rounds: Encouraging more patients to choose an IUD

June 1, 2007

Recent FDA label changes that put to rest safety concerns about IUDs make them an excellent first-line contraceptive option for most of your patients-even those not in a monogamous relationship.

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ACCREDITATION
This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of CME2, Inc.(?cme2?) and Contemporary OB/GYN. cme2 is accredited by the ACCME to provide continuing medical education for physicians.

cme2 designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit?. Physicians should only claim credit commensurate with the extent of theirparticipation in the activity.

TARGET AUDIENCE
Obstetrician/gynecologists and women?s health practitioners.

EDUCATIONAL OBJECTIVES
After completing the following CME activity, the reader should be able to:

  • Detail the contraindications for the use of the Copper T 380A IUD under new FDA labeling. 

  • Restate the unique advantages that the levonorgestrel IUS and Copper T 380A IUD offer as contraceptive methods. 

  • Describe the significance of a prior history for ectopic pregnancy when considering using an IUD for future contraception. 

  • Restate the clinical scenarios which are appropriate for using an IUD as a method of contraception. 

TO EARN CREDIT FOR THIS ACTIVITY
Participants should study the article and log onto http://www.contemporaryobgyn.net, where they must pass a post-test and complete an online evaluation of the CME activity. After passing the post-test and completing the online evaluation, a CME certificate will bee-mailed to them. The release date for this activity is June 1, 2007. The expiration date is June 1, 2008. 

DISCLOSURES 
Editors Elizabeth A. Nissen and Paul L. Cerrato disclose that they do not have any financial relationships with any manufacturer in this area of medicine.

The manuscript reviewer discloses that she has no financial relationships with any manufacturer in this area of medicine.

Dr. Ogburn discloses that he received product research support from Duramed Pharmaceuticals (a subsidiary of Barr Pharmaceuticals), maker of the Paragard IUD. Dr. Espey discloses that she has no financial relationships with any manufacturer in this area of medicine.

RESOLUTION OF CONFLICT OF INTEREST
cme2 has implemented a process to resolve conflicts of interest for each continuing medical education activity, to help ensure content objectivity, independence, fair balance, and that the content is aligned with the interest of the public. Conflicts, if any, are resolved through a peer review process. 

UNAPPROVED/OFF-LABEL USE DISCUSSION
Faculty may discuss information about pharmaceutical agents, devices, or diagnostic products that are outside of FDA-approved labeling. This information is intended solely for CME and is not intended to promoteoff-label use of these medications. If you have questions, contact the medical affairs department of the manufacturer for the most recent prescribing information. Faculty are required to disclose any off-label discussion.

A 16-year-old patient named Elena has just delivered her second baby. For the last 4 months she has been "dating" the baby's father, who uses condoms. She has used pills in the past but "forgets to take them a lot." Elena requests an IUD and wants a "sure" method so that she can finish high school. What would you do?

Getting more of your reproductive-aged patients to use intrauterine devices (IUDs) just might make a dent in the soaring unintended pregnancy rate in this country. But does the teenager above meet today's expanded criteria? We'll revisit that scenario-and four others-shortly.

The most common form of reversible contraception throughout the world, IUDs are safe and highly effective.1 So why is their use in the United States so dismally low-with fewer than 2% of women choosing an IUD as their contraceptive method?2 Low rates result partly from misperceptions about the IUD by clinicians and patients alike, as well as persistent negative impressions lingering from the Dalkon Shield controversy of the 1970s.

The two IUDs currently available in the US have a long history of safety and efficacy:

  • The levonorgestrel intrauterine system (LNG-IUS) releases a small amount of levonorgestrel each day and for many patients results in lighter-to-absent menstrual flow. It is approved for up to 5 years of use.
  • The Copper T 380A intrauterine device (Copper IUD) has the advantage of being a nonhormonal method of contraceptive and is approved for up to 10 years.

Fortunately, American women are beginning to get the message, with IUD use in the US having risen from 0.5% in 1995 to 1.3% in 2002, the most recent year for which data are available.2. One way to increase IUD use is to expand the "ideal" or "reasonable" patient profile. Traditionally in the US, IUDs have been considered a method of last resort. Recommendations had been to place an IUD only in an ideal candidate described as multiparous, monogamous, and having completed childbearing.3 These recommendations, which were not based on good evidence, have limited the use of an excellent form of contraception for many women.

In 2005 the Food and Drug Administration approved more liberal package labeling for the Copper T IUD. Our purpose here is to review these changes and discuss other clinical situations where you can consider IUDs.

New labeling for Copper IUDs expands the patient profile

The FDA label changes expand the profile of women considered appropriate candidates for the IUD. The changes also clarify some relative contraindications included in the previous label (Table 1). Although the label change was requested and made for the Copper T 380A, the changes (with the exception of Wilson's disease and copper allergy) apply equally to the LNG-IUS.

REMOVED FROM THE NEW LABEL as contraindications were:

  • "history of PID" (pelvic inflammatory disease) and "patient or partner with multiple partners." The new wording emphasizes current behavior that increases the risk of PID.
  • "unresolved Pap smears." Removal of those words allows clinicians to place IUDs in women who are being followed expectantly for lower grade dysplasia.
  • "increased susceptibility to infection" as a contraindication emphasizes the lack of data that immunocompromised patients are more likely to develop PID when they use an IUD.
  • "genital actinomycosis." The removal of this contra-indication resolved the confusion between true genital actinomycosis, an extremely rare pelvic infection involving actinomyces, and asymptomatic actinomyces on a Pap smear, a very common finding in women who have used an IUD long-term. The label change clarifies that the latter finding is not a contraindication for IUDs.

Clinical scenarios

The following cases illustrate situations in which an IUD traditionally may not have been considered a good contraceptive option or where data were not available to prove the safety of insertion.

Case A: Ectopic pregnancy

Amanda, a 28-year-old gravida 1, para 0, successfully treated with methotrexate for an ectopic pregnancy 1 year ago, desires contraception for the next 3 to 5 years.

Prior ectopic pregnancy has traditionally been considered a contraindication for an IUD. In fact, the LNG-IUS package insert specifies that women with a "history of ectopic pregnancy or condition that would predispose to ectopic pregnancy" are not good candidates for the IUD. This caution is based on the concern that IUDs may increase the risk of ectopic pregnancy.

But case–control and prospective studies that have examined the risk of ectopic pregnancy in women who use IUDs suggest otherwise.4,5 IUDs protect against intrauterine pregnancy better than ectopic, but still effectively decrease the rate of ectopics relative to nonusers (nonusers ~1 in 70 vs. 2/1,000 for IUD users). IUDs protect very well against ectopic pregnancy, reducing the risk by 70% to 0.2/1,000 In other words, the risk of ectopic pregnancy is one tenth that of a woman who doesn't use a contraceptive. In fact, the IUD reduces the risk of ectopic pregnancy sufficiently for the World Health Organization (WHO) to allow "routine recommendation" of IUDs in women with a history of ectopic pregnancy.6

BOTTOM LINE: A Copper T IUD or LNG-IUS would be very appropriate for Amanda, although it would be an off-label use for the LNG-IUS, since the labeling has not been changed.

Case B: Immediate postpartum insertion

Brenda, a 33-year-old gravida 6, para 5, says she would like an IUD for postpartum contraception. She was noncompliant with prenatal care, attending only two of her prenatal care visits.

Immediate postpartum insertion of a copper IUD is safe and effective.7 Postpartum is an ideal time for insertion as patients are highly motivated to initiate contraception and are known not to be pregnant.

An increased risk of expulsion is the chief concern that has prevented immediate insertion in the US. That risk appears to be elevated from a baseline of 2% to 3% with interval insertion to 10% to 15% with immediate postpartum insertion.7 However, pregnancy rates do not appear to be increased, most likely because patients recognize the expulsion and return for replacement of the IUD or alternative contraception. For some populations, however, returning for the postpartum check-up is a significant obstacle. In one study, only 60% of patients who requested an IUD for postpartum contraception actually obtained it during the postpartum period.8

Immediate postpartum insertion should be performed within 10 minutes of delivery of the placenta with minimal patient discomfort. Why that timeframe? Although the literature is sparse, there is concern that the risk of perforation or expulsion is increased with a longer interval to insertion. The IUD may be inserted manually, using a ring forceps, or simply with the insertion device used for interval insertion. The strings can be left long and cut at a visit in 2 to 4 weeks. At the follow-up visit, check for expulsion and trim the strings to an appropriate length after uterine involution.

BOTTOM LINE: Immediate postpartum insertion would be a reasonable consideration for a patient like Brenda, who wasn't very compliant with her prenatal schedule.

Case C: Nulliparous diabetic

Celine, a 21-year-old nullipara with type 1 diabetes, is in a monogamous relationship and desires long-term contraception. She was referred to the family planning clinic for an IUD. She may be interested in childbearing in 5 to 6 years.

Many clinicians are unwilling to insert IUDs in nulliparous patients and women with diabetes because they are concerned about infection and infertility. This patient has both conditions. Diabetes and other diseases that can compromise the immune system could theoretically increase the risk of pelvic infection.

However, two prospective comparison trials of type I diabetics and one prospective cohort trial of type II diabetics (including a total of 338 patients) found no increased risk of PID, no decrease in efficacy, and high continuation rates with IUD use.9,10 Despite this, nulliparity has long been considered a relative contraindication to IUD insertion. The very name "Paragard" implies its ideal use for "parous" women. But although early case–control studies from the 1980s showed increased infertility in nulliparas with a history of IUD use, when these studies were corrected for number of sexual partners, no differences remained.

In 2001, a case–control study of 1,895 women with tubal infertility showed no association with previous IUD use.11 Instead, infertility was associated with the presence of antibody to chlamydia. Prospective noncomparative studies of acceptability in nulliparous women have been generally favorable.

Furthermore, a Spanish study followed 525 nulligravid women with IUDs and compared them with 2,770 parous women with IUDs. Continuation at 4 years was 60%. For the 74 who had the IUD removed for a planned pregnancy, 89.6% became pregnant within 3 months. No cases of PID in this cohort were reported. The study concluded that the IUD was just as reliable and effective for nulliparous women as for multiparous women.12

BOTTOM LINE: Although a perception exists that insertion is more difficult in nulliparas and that they have higher discontinuation rates due to pain, the evidence from this study argues against this. An IUD would provide excellent contraception for patients like Celine.

Case D: Copper IUD for emergency contraception

Dana, a 35-year-old gravida 2, para 2, who uses condoms, presents for emergency contraception because the condom broke during intercourse last night. She is interested in long-term contraception.

Copper-containing IUDs are highly effective at preventing pregnancy when used up to 7 days after unprotected intercourse. Pregnancy is prevented 99% of the time with a copper IUD compared to an 88% reduction with a high-dose progestin such as Plan B (0.75-mg levonorgestrel emergency contraception tablets).13 No studies have evaluated the LNG-IUS, although it is likely to be effective as well. This patient would be an excellent candidate for an IUD. It would provide both highly effective emergency and ongoing contraception.

BOTTOM LINE: Educate patients about the availability of emergency contraception and consider offering an IUD to women like Dana who need emergency contraception and long-term contraception. Setting up a practice in which contraception is considered an "emergency" can improve access for patients in this situation.

Case E: Teen multiparous patient not in a long-term monogamous relationship

We return now to Elena, the 16-year-old gravida 2, para 2 who in our opening example had just delivered her second baby. For the last 4 months she has been "dating" the baby's father, who uses condoms. She has used pills in the past but "forgets to take them a lot." She requests an IUD, which she heard about from a friend, and wants a "sure" method so that she can finish high school.

Perhaps the most controversial case, Elena meets two traditional criteria for discouraging an IUD:
1. she is a teenager, and
2. she is not in a long-term monogamous relationship.

Her risk of rapid repeat pregnancy is high-as is the probability that she will live in poverty. Her situation is quite compelling for a long-term coitus-independent method of contraception. The data are reassuring that the IUD doesn't cause PID, except for the first 20 days after insertion. During that time, the risk of PID is increased by a factor of 6, but the absolute risk is still very low. After the first 20 days, rates of PID drop down to the background rate for the next 8 years. In 22,908 IUD insertions, investigators found a risk of PID after 20 days of 1.4 cases per 1,000 woman-years of use with stable rates at up to 8 years of follow-up.14 As noted, the new FDA guidelines no longer specify a monogamous relationship for IUD use.

BOTTOM LINE: It is certainly important to counsel a patient like Elena that IUDs do not protect against STDs and that a dual method, both the IUD and condoms, would be the most appropriate for excellent pregnancy and STD prevention.

Intrauterine devices are a safe, highly effective form of reversible contraception that are underutilized in the US. Recent evidence-based FDA labeling changes should reduce provider concerns about offering IUDs to a broader range of women. Increased use of intrauterine devices could provide a partial solution to the epidemic of unintended pregnancy in this country. Instead of reserving IUDs for the traditional "ideal candidate," consider the IUD as an excellent first-line contraceptive option for the majority of women across the reproductive life spectrum.

REFERENCES

1. Population Reference Bureau, Washington DC. Family Planning Worldwide 2002 Data Sheet. 2002.

2. Mosher WD, Martinez GM, Chandra A, et al. Use of contraception in the United States: 1982-2002. Adv Data. 2004;(350):1-36.

3. Espey E, Ogburn T. Perpetuating negative attitudes about the intrauterine device: textbooks lag behind the evidence. Contraception. 2002;65:389-395.

4. Xiong X, Buekens P, Wollast E. IUD use and the risk of ectopic pregnancy: a meta-analysis of case-control studies. Contraception. 1995;52:23-34.

5. Sivin I. Dose- and age-dependent ectopic pregnancy risks with intrauterine contraception. Obstet Gynecol. 1991;78:291-298.

6. World Health Organization. Improving access to quality care in family planning. Medical eligibility criteria for contraceptive use. 2nd ed. WHO; 2000.

7. Grimes D, Schulz K, Van Vliet H, et al. Immediate post-partum insertion of intrauterine devices. Cochrane Database Syst Rev. 2003;(1):CD003036. Review.

8. Ogburn JA, Espey E, Stonehocker J. Barriers to intrauterine device insertion in postpartum women. Contraception. 2005;72:426-429.

9. Skouby SO, Molsted-Pedersen L, Kosonen A. Consequences of intrauterine contraception in diabetic women. Fertil Steril. 1984;42:568-572.

10. Kimmerle R, Weiss R, Berger M, et al. Effectiveness, safety, and acceptability of a copper intrauterine device (CU Safe 300) in type I diabetic women. Diabetes Care. 1993;16:1227-1230.

11. Hubacher D, Lara-Ricalde R, Taylor DJ, et al. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. N Engl J Med. 2001;345:561-567.

12. Duenas JL, Albert A, Carrasco F. Intrauterine contraception in nulligravid versus parous women. Contraception. 1996;53:23-24.

13. Cheng L, Gulmezoglu AM, Oel CJ, et al. Interventions for emergency contraception (Cochrane Review). In: The Cochrane Library, Issue 3, 2004. Chichester, UK: John Wiley & Sons. Ltd.

14. Farley TM, Rosenberg MF, Rowe PJ, et al. Intrauterine devices and pelvic inflammatory disease: an international perspective. Lancet. 1992;339:785-788.