In this large, observational study of women with SLE, we found that a minority of women with SLE at risk for unplanned pregnancy reported receipt of contraceptive counseling or use of effective contraception. Although many women reported always using contraception (78%), most reported use of barrier methods, which have 1-year failure rates with typical use that range from 15–32% (19
). Barrier methods were the most common form of contraception even in the subset of women without a history of thrombosis or aPL. In addition, we found that an important predictor of both contraceptive counseling and use was involvement of an obstetrician/gynecologist in clinical care.
Although ours is the first study to investigate the receipt of contraceptive counseling among women with SLE, our findings regarding contraceptive use are consistent with two recent studies. In a U.S. study performed in an SLE referral clinic, barrier methods were also the most commonly used form of contraception (47%), followed by estrogen-containing contraception (24%). Use of intrauterine devices was low (4%) (20
). In a Finnish study that compared women with SLE under the age of 46 from a hospital registry to population controls, those with SLE were more likely to use IUDs than population controls (13 versus 5%), but less likely to use oral contraceptives (18 versus 28%) (21
). Similar to our findings, these studies suggest that use of effective contraception by women with SLE is relatively low.
Unintended pregnancies, whether they are mistimed or unwanted, are especially problematic for women with SLE. While the Institute of Medicine has documented many negative social and economic consequences of unintended pregnancy (22
), women with SLE and their fetuses may face unique negative health consequences. Women with active disease in the first trimester have an increased risk of pregnancy loss, particularly stillbirth (3
). One study found that proteinuria or thrombocytopenia in the first trimester increased the risk for pregnancy loss to nearly 40% (23
). Several studies have shown that patients with active lupus nephritis have a significantly increased risk for pregnancy loss, preterm birth and pre-eclampsia (1
). In addition, another important finding that has emerged from the literature is that inactive disease in the six months prior to conception portends a good prognosis; women with inactive disease are dramatically less likely to flare during pregnancy than those with moderate/severe disease (8% versus 58%) (3
). Therefore, patients with SLE should be encouraged to carefully time pregnancy to coincide with periods of prolonged disease quiescence.
Another factor complicating unintended pregnancies in SLE is the risk to the fetus of exposure to potentially teratogenic medications. Among the 86 women at risk for unintended pregnancy in our study, over half were taking potentially teratogenic medications. Even among this subgroup, only a minority of patients reported receipt of contraceptive counseling in the last year and few were using effective contraceptives. Contraceptive counseling during clinical care is the main approach to reducing the risk of unintended pregnancy, and has previously been advocated by the U.S. Preventive Services Task Force for the general population (26
). Although studies comparing the effectiveness of contraceptive counseling techniques for women with SLE are needed (27
), at least one large study demonstrates that counseling increases the use of effective contraception in the general population (29
). In SLE, we have recently developed a quality measure specifying that contraceptive counseling should be documented in the medical record of all women at risk for pregnancy who are initiating potentially teratogenic medications (30
). Our findings suggest that patients with SLE have significant unmet needs for contraceptive counseling and should be targeted for quality improvement.
In response to the growing literature regarding pregnancy risks in SLE, the Centers for Disease Control (CDC) recently adapted the World Health Organization’s (WHO) medical eligibility criteria (MEC) for contraceptive use and highlighted SLE as a condition in which unintended pregnancy may pose an unacceptable health risk (31
). The report states that women with SLE “should be advised that sole use of barrier methods for contraception and behavior-based methods of contraception may not be the most appropriate choice because of their relatively higher typical-use rates of failure.” Current literature suggests that all available barrier methods have high one-year failure rates with typical use (male condom: 15%, female condom: 21%, diaphragm with spermicide: 16%, cervical cap and sponge: 16% in nulliparous women and 32% in parous women). This contrasts with much lower failure rates with typical use seen with hormonal contraceptives (8% for the patch, ring, and progestin-only or combination estrogen-progestin pills, and 3% for Depo-Provera). The lowest failure rates are achieved with IUDs (<0.8% for copper T, and 0.2% for levonorgestrel-IUD) and Implanon (0.05%) (19
A history of thrombosis or aPL can narrow contraceptive options in women with SLE. Previous thrombosis is a contraindication for the use of estrogen-containing contraceptives (31
). Two women in our sample, both with a history of documented thrombosis (stroke and myocardial infarction), reported inappropriate use of estrogen-containing contraceptives. In women without a history of thrombosis, but with aPL, the CDC MEC also advises consideration of alternatives to estrogen-containing contraceptives (31
). Two women in our sample with a history of documented aPL but no previous thrombosis reported use of estrogen-containing contraceptives. Future studies are needed to further evaluate the prevalence of such inappropriate medication use in SLE. Given growing national attention to the larger human and economic consequences of medication-related problems in the United States (33
), creating tools to minimize these problems is a priority, and may provide an opportunity to decrease adverse events in patients with SLE.
Although estrogen-containing contraceptives are contraindicated for women with a history of thrombosis or aPL, other contraceptive methods can be recommended for this group of women (34
). First, progestin-only methods (pills, injections, implants, or IUDs) do not increase the risk of thrombosis in the general population. However, a small increased risk in women with SLE can not be definitively ruled out, given that sufficiently powered, controlled studies in women with SLE or a history of aPL or thrombosis are lacking (8
). One randomized trial that did not exclude women with a history of aPL reported four thrombotic events, two in women taking combined hormonal contraceptives, and two in women taking progestin-only contraceptives (with no events in the copper-IUD group); all women with a thrombotic event had low titer aPL (between 26 and 33% of women were aPL positive at baseline) (6
). However, these findings are difficult to interpret given that the trial was not powered to detect adverse events. An international, multicenter, case-control study sponsored by the WHO in the general population found that the lower doses of hormones used in currently available progestin-only contraceptives do not significantly influence hemostasis (36
). Two additional studies, including a recent national cohort study that examined a variety of progestin-only methods, including the levonorgestrel-containing IUD, also found no additional risk of thrombosis (37
Although this data provides some reassurance, because women with a history of thrombosis were not specifically studied (or were excluded) from these studies, direct extrapolation to women with SLE and aPL or thrombosis is not possible. Still, when the adverse health effects and increased thrombotic risks related to pregnancy itself are considered, it is likely that the benefits of progestin-only contraceptives outweigh the theoretical risk for most women with SLE. Of the progestin-only methods, the levonorgestrel-containing IUD results in the lowest blood levels of hormone, and like all hormonal methods, has the additional benefit of decreasing menstrual blood flow. Lastly, the copper-IUD is considered a safe method for all women with SLE. Previous concerns about an increased risk of infection in immunocompromised patients appear unfounded (8
A strength of this study is that we applied a detailed survey algorithm to precisely define the population of women with SLE at risk for unplanned pregnancy. We included only women 44 years of age and younger who were pre-menopausal, while excluding all women who were not sexually active with men at the time of the interview and those reporting medical or surgical infertility in either themselves or their male partners. Although recall bias is possible in our study, patient self-report may be a preferrable method for obtaining information about receipt of contraceptive counseling, since counseling is often not included in the medical record (and if included, does not mean that the patient understood or internalized the information provided) (39
). Underreporting of unintended pregnancies and induced abortions has been found in other surveys (42
); it is therefore likely that only half of the unintended pregnancies and induced abortions that occurred for women in the LOS were captured. Only two-thirds of our sample had aPLs available, so we cannot rule out underascertainment of inappropriate estrogen use. Limitations of our study include the cross-sectional design, which precludes the demonstration of causal relationships between contraceptive counseling and use, and limited sample size, which did not allow us to build more comprehensive multivariate models in our analysis of contraceptive use and counseling. In addition, our findings may not be generalizable to other patient populations with SLE. In particular, although our study consisted of a diverse patient population, non-English speaking individuals were excluded. Also, participants in the LOS have a relatively high level of educational attainment; women with lower educational levels may be even less likely to use effective contraception (44
In summary, we found that most women with SLE at risk for unplanned pregnancy reported no contraceptive counseling in the past year, despite common use of potentially teratogenic medications. Many women relied on contraceptive methods with relatively high failure rates and few used IUDs, a method offering effective, reversible contraception without increasing vascular risk. More generous prescription drug coverage policies that reduce out-of-pocket payments for contraceptives, particularly IUDs, have significant potential to increase their use, and should be considered for women with SLE (45
). Four women with a history of thrombosis or aPL were inappropriately taking estrogen-containing contraceptives, suggesting a potential opportunity for quality improvement in this group. Seeing an obstetrician/gynecologist significantly increased the odds of receiving contraceptive counseling. Facilitating women’s access to a family planning specialist may therefore be an important mechanism to increase contraceptive counseling and use. However, inter-specialty differences also suggest a need for rheumatologists, generalists, or other specialists caring for individuals for SLE to include contraceptive counseling in routine clinical care.