Associate Professor, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants Hospital, Providence, RI
Dr. Allen reports she is a Nexplanon trainer for Merck.
SYNOPSIS: In this secondary analysis of the Contraceptive CHOICE Project, there was no difference in copper intrauterine device continuation rates at one year between 165 women who reported heavy menstrual bleeding at baseline and 753 women who did not.
SOURCE: Hobby JH, Zhao Q, Peipert JF. Effect of baseline menstrual bleeding pattern on copper intrauterine device continuation. Am J Obstet Gynecol 2018;219:465.e1-5.
This was a secondary analysis of the Contraceptive CHOICE Project, a prospective cohort study from 2007 to 2013 that included 9,256 girls and women in the St. Louis area. Researchers offered the participants two to three years of free contraception of their choice. Eligible participants were between the ages of 14 and 45 years, sexually active with a male partner, and interested in initiating or changing their contraceptive method. Participants were asked to rate their baseline menstrual bleeding as light (using ≤ 10 pads/tampons per period), moderate (11-20 pads/tampons), moderately heavy (21-30 pads/tampons), heavy (> 30 pads/tampons), or too irregular/variable to say. Method continuation was assessed by phone calls three and six months after initiation and then every six months for the duration of the study. The primary outcome was copper intrauterine device (IUD) discontinuation at 12 months. Only two copper IUD users reported that their menses were too irregular to describe, and they were excluded from the analysis. For analysis, women reporting heavy and moderately heavy bleeding were grouped together as “heavy,” and women reporting light and moderate bleeding were grouped together as “not heavy.”
A total of 1,102 women chose the copper IUD, and continuation data were available for 918 women at 12 months. Of these 918 women, 165 reported bleeding as heavy (n = 24) or moderately heavy (n = 141), and 753 reported bleeding as light (n = 192) or moderate (n = 561). Participants in the heavy/moderately heavy category were more likely to be obese and have a history of sexually transmitted infection than women in the light/moderate category. Otherwise, there was no difference between the two groups in terms of age, race, ethnicity, education, income, gravidity, and parity. At 12 months, continuation rates were similar, with 80.2% in the “heavy” group and 85% in the “not heavy” group (P = 0.24). The hazard ratio for early discontinuation in the “heavy group” was 1.21 (95% confidence interval, 0.88-1.66). No other predictors of discontinuation were found.
COMMENTARY
Most gynecologic providers are familiar with the copper IUD, which has been available in the United States since 1988. The device is approved by the U.S. Food and Drug Administration for 10 years of use, although one study has indicated efficacy up to 12 years.1 The device is highly effective, with failure rates of less than 1%. Counseling for the copper IUD typically has included the warning that the device may increase menstrual bleeding and cramping. Where did this advice come from? One small study of 18 women measured menstrual blood loss before and after insertion of the copper IUD, as measured by the alkaline hematin method.2 At three months, menstrual blood loss increased by 55%, from 59 mL to 91 mL on average, and remained stable over the next nine months. Nevertheless, there was no significant change in hemoglobin levels among participants over the course of the study. This has been confirmed in other trials that generally have shown no clinically significant changes in hemoglobin levels among women using the copper IUD, even among women with baseline anemia, despite a 50% increase in menstrual blood loss.3 This has led the Centers for Disease Control and Prevention (CDC) to recommend not screening for anemia prior to copper IUD insertion4 and labeling use of the copper IUD as category 2 (benefits outweigh risks) among women with baseline anemia.5
Rather than assessing the amount of bleeding while using the copper IUD, the goal of this study was to assess whether women with heavy menstrual bleeding at baseline were more likely to discontinue their copper IUD by 12 months. Interestingly, the study did not show that women with heavy or moderately heavy menstrual bleeding were more likely to request the copper IUD be removed. Some might argue that this is a more clinically relevant outcome. This finding also brings into play the subjective nature of our patients’ menstrual bleeding assessments. This may be interpreted as a weakness or strength of the study. As a weakness, the investigators did not quantify the baseline menstrual bleeding pattern objectively. However, as a strength, the study is practical, as providers do not perform objective measurements of menstrual blood loss in the office. Clinicians rely on patients’ subjective reports of whether they are bothered by the amount of bleeding they are having. In the Hobby et al study, women reporting heavy or moderately heavy menstrual bleeding were just as happy to continue the copper IUD as women reporting light or moderate menstrual bleeding. The authors speculated that these women may be more tolerant of heavy menstrual bleeding in general. Study limitations include the retrospective measure of menstrual blood loss (recalling pad/tampon use) and the fact that there were only 24 women in the original heavy menstrual bleeding group. This may reflect that women with heavy menstrual bleeding self-selected out of the copper IUD group in the first place.
Despite these limitations, this study reminds us that, as providers, we must try to prevent our biases from entering the exam room and counsel all women honestly about the copper IUD. We should not assume automatically that women with heavy menstrual bleeding would not be interested in the copper IUD or that all women would prefer the levonorgestrel IUD. Experts speculate that the increase in menstrual blood loss seen with the copper IUD is caused by higher levels of prostaglandins in the endometrium.6 In general, women can be counseled that unscheduled spotting or heavy menstrual bleeding, especially during the first three to six months of use, may occur with the copper IUD. Nevertheless, for most women, these side effects will decrease over time and are manageable. Although prophylactic ibuprofen has not been shown to decrease copper IUD removals, the use of nonsteroidal anti-inflammatory drugs (NSAIDs) can be helpful for a current bleeding episode with the copper IUD.6 The CDC Selected Practice Recommendations for Contraceptive Use recommends five to seven days of NSAIDs for women complaining of heavy bleeding while using the copper IUD.4 In sum, the copper IUD is safe, reversible, hormone-free, and highly effective, making it an attractive contraceptive option for women.
REFERENCES
- Long-term reversible contraception: Twelve years of experience with the TCu380A and TCu220C. Contraception 1997;56:341-352.
- Milsom I, Andersson K, Jonasson K, et al. The influence of the Gyne-T 380S IUD on menstrual blood loss and iron status. Contraception 1995;52:175-179.
- Tepper NK, Steenland MW, Marchbanks PA, Curtis KM. Hemoglobin measurement prior to initiating copper intrauterine devices: A systematic review. Contraception 2013;87:639-644.
- Curtis KM, Jatlaoui TC, Tepper NK, et al. US Selected Practice Recommendations for Contraceptive Use, 2016. MMWR Recomm Rep 2016;65:1-66.
- Curtis KM, Tepper NK, Jatlaoui TC, et al. US Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep 2016; 65:1-103.
- Godfrey EM, Folger SG, Jeng G, et al. Treatment of bleeding irregularities in women with copper-containing IUDs: A systematic review. Contraception 2013;87:549-566.
In this secondary analysis of the Contraceptive CHOICE Project, there was no difference in copper intrauterine device continuation rates at one year between 165 women who reported heavy menstrual bleeding at baseline and 753 women who did not.
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