Obstetrics & Gynecology:
Copper Intrauterine Device for Emergency Contraception: Clinical Practice Among Contraceptive Providers
Harper, Cynthia C. PhD; Speidel, J. Joseph MD, MPH; Drey, Eleanor A. MD, EdM; Trussell, James PhD, BPhil; Blum, Maya MPH; Darney, Philip D. MD, MSc
From the Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California; the Office of Population Research, Princeton University, Princeton, New Jersey; and the Hull York Medical School, Hull, England.
Supported by the William and Flora Hewlett Foundation and was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development grant for Infrastructure for Population Research at Princeton University, grant R24HD047879. All analyses, interpretations, or conclusions are those of the authors.
The authors thank Peter Belden for his motivation for this work and German Rodriguez for his statistical expertise.
Corresponding author: Cynthia C. Harper, PhD, Associate Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, Box 0744 UCSF, 3333 California St, Suite 335, San Francisco, CA 94118; e-mail: firstname.lastname@example.org.
Financial Disclosure Dr. Harper received grant support through the University of California, San Francisco, from Teva Pharmaceutical Industries for research work on Plan B and Plan B One-Step emergency contraception in the past. Dr. Speidel is a consultant for Woman Care Global and Medicines360, both of which are nonprofit organizations. The other authors did not report any potential conflicts of interest.
OBJECTIVE: The copper intrauterine device (IUD) is the most effective emergency contraceptive available but is largely ignored in clinical practice. We examined clinicians' recommendations of the copper IUD for emergency contraception in a setting with few cost obstacles.
METHODS: We conducted a survey among clinicians (n=1,246; response rate 65%) in a California State family planning program, where U.S. Food and Drug Administration-approved contraceptives are available at no cost to low-income women. We used multivariable logistic regression to measure the association of intrauterine contraceptive training and evidence-based knowledge with having recommended the copper IUD for emergency contraception.
RESULTS: The large majority of clinicians (85%) never recommended the copper IUD for emergency contraception, and most (93%) required two or more visits for an IUD insertion. Multivariable analyses showed insertion skills were associated with having recommended the copper IUD for emergency contraception, but the most significant factor was evidence-based knowledge of patient selection for IUD use. Clinicians who viewed a wide range of patients as IUD candidates were twice as likely to have recommended the copper IUD for emergency contraception. Although more than 93% of obstetrician–gynecologists were skilled in inserting the copper IUD, they were no more likely to have recommended it for emergency contraception than other physicians or advance practice clinicians.
CONCLUSION: Recommendation of the copper IUD for emergency contraception is rare, despite its high efficacy and long-lasting contraceptive benefits. Recommendation would require clinic flow and scheduling adjustments to allow same-day IUD insertions. Patient-centered and high-quality care for emergency contraception should include a discussion of the most effective method.
LEVEL OF EVIDENCE: III
The copper-releasing intrauterine device (IUD) can be used safely for emergency contraception up to 5 days after unprotected intercourse, reducing the risk of pregnancy by more than 99%.1 Few contraceptive providers, however, inform women about the copper IUD when they present for emergency contraception, although its efficacy is significantly higher than that of levonorgestrel or ulipristal-acetate emergency contraceptive pills.2–5 Pills have several advantages, including convenience and availability during extended pharmacy hours outside of a clinic setting (levonorgestrel without a prescription to those aged 17 and older). Copper IUDs also have associated risks and side effects, including heavy bleeding and expulsion, although some of the risks are smaller among skilled providers; results from a major trial of the copper IUD for emergency contraception showed no perforations or infections.4 Whereas scientific and public health efforts helped to increase the availability of emergency contraceptive pills, the pill formulations do not provide ongoing protection, and increased access to emergency contraceptive pills has not yet led to lower pregnancy rates.6–8 The copper IUD not only confers greater protection from the one act of unprotected intercourse, but also offers protection for at least 10 years.9 Scientific evidence on the effectiveness and safety of the copper IUD is well-established, but the method has been largely left out of emergency contraception initiatives and is rarely promoted for use after unprotected intercourse.
Women in the United States, especially young women at elevated risk for unintended pregnancy, are unlikely to know about intrauterine contraception, even as ongoing contraception;10 those who hear about it from their providers are almost three-times as likely to be interested in the method.11 Surveys of women seeking emergency contraception or pregnancy testing have shown that more than 10% would accept a copper IUD.12,13 Most women seeking emergency contraception are in need of regular contraception, and evidence now supports use of the copper IUD among women in the United States at highest risk for unintended pregnancy, including adolescents, unmarried women, and nulliparous women.14
An evidence-based approach would offer women information and access for the most effective methods, as well as educate them about a range of contraceptive options. Although offering the copper IUD for emergency contraception is still an innovative approach in the United States, there are some contraceptive providers who do make it available to their patients. This study assessed clinicians' professional training, skills, knowledge, and practices to identify factors that were associated with having recommended the copper IUD for emergency contraception.
MATERIALS AND METHODS
We conducted an analysis of a 2006 survey of contraceptive providers participating in the California State program, Family PACT (Planning, Access, Care, and Treatment), which offers complete coverage for contraceptives to women up to 200% of poverty level. The survey included in the sample all clinicians serving 100 or more female contraceptive patients per year; a self-administered written survey was sent to 1,246 clinicians, identified by unique study identification numbers. The survey sample size was designed to provide sufficient power to calculate differences between physicians and nonphysicians in the general provision of intrauterine contraception (Harper et al15 gives detailed methodology). For the purposes of this analysis using logistic regression to assess the recommendation of the copper IUD for emergency contraception, with the assumptions of a one-tailed test and significance of 0.05, we had a power of 90% to detect a difference in the outcome by the predictor IUD insertion skills (18% very comfortable with insertion of copper IUD), adjusting for the other covariates in the model. The survey was pretested and included items from published clinician surveys on intrauterine contraception.16,17 An information letter was sent, and then 2 weeks later the survey was mailed with a cover letter. A reminder postcard was sent later that week, and another survey was sent to nonrespondents after 4 weeks. Providers were telephoned up to four times with reminders to complete the survey. On survey completion, they were mailed a box of See's chocolates. The study was approved by the institutional review board at the University of California, San Francisco, the Committee of Human Research (H11760-28435-03).
Clinicians were asked how many times they had recommended the copper IUD for emergency contraception, and the outcome measure was categorized dichotomously (yes or no) for having recommended it. The survey also collected data on intrauterine contraception training, competency, knowledge, and counseling and provision practices. The number of IUDs inserted in core training or residency is measured; current comfort level in inserting copper IUDs (very comfortable, somewhat comfortable, a little comfortable, not at all comfortable); intrauterine contraception available at practice (yes or no); frequency of intrauterine contraception counseling for contraceptive patients (always, most of the time, some of the time, rarely, never); sufficient experience to counsel patients on copper IUD use (strongly agree, agree, disagree, strongly disagree); time to counsel patients on contraceptive options (strongly agree, agree, disagree, strongly disagree); and patients receptive to learning about intrauterine contraception (strongly agree, agree, disagree, strongly disagree).
We used a nine-item scale variable to measure the clinicians' views on patient selection for intrauterine contraception use, which was highly associated in previous analyses with clinician provision of intrauterine contraception to patients.15 We asked clinicians whether the following women were suitable candidates: nulliparous, immediate postpartum, immediate postabortion, adolescents, history of ectopic pregnancy, sexually transmitted disease in past 2 years, pelvic inflammatory disease in past 5 years, current bacterial vaginosis, and human immunodeficiency virus positivity. Items correspond to eligible candidates according to the Centers for Disease Control medical eligibility criteria for contraception; if a provider responded that they were suitable candidates, then their knowledge of eligible candidates was more evidence-based.14 The internal consistency or reliability of the scale, 0.77, was measured through Cronbach alpha.18 We also measured clinician knowledge of intrauterine contraception of basic method characteristics and benefits and side effects with a 12-item scale on side effects, including bleeding patterns; the scale reliability coefficient was 0.86.
The survey included demographic (age, sex) and professional characteristics of the clinicians (obstetrician–gynecologist (ob-gyn) physician or midlevel practitioner, family medicine or other physician or midlevel practitioner), practice setting (private office, public, or nonprofit, urban location), and patient volume (number of female contraceptive patients annually).
The outcome variable we assessed was clinician's recommendation of the copper IUD for emergency contraception to patients, coded dichotomously (yes or no), and the analyses are limited to respondents with data for this variable (n=788). We presented clinician recommendation of copper IUD for emergency contraception to patients, by demographic, by professional and practice characteristics, as well as by intrauterine contraception knowledge and skills, using χ2 tests for categorical variables and t tests for continuous variables. We analyzed clinician and practice factors associated with recommendation of the copper IUD for emergency contraception to patients using multivariable logistic regression analysis. We included predictor variables that are conceptually relevant and important in previous research on clinician practices with intrauterine contraception, including demographic variables, practice setting, patient volume, and intrauterine contraception training and knowledge. We estimated two models, with the first one focused on clinician core training and professional practice and the second focused on current skills and clinical practice. Stata/SE 11.1 was used for analyses. Reported differences are significant at P≤.05.
A total of 816 clinicians responded to the survey, with a response rate of 65%. Contraceptive providers participating in the survey included physicians (49%), nurse practitioners (36%), and physician assistants (15%). The largest specialties were obstetrics and gynecology (35%), family medicine (37%), and women's health (12%). An analysis of respondents compared with nonrespondents, based on claims data, showed no differences by professional title, urban location, or intrauterine contraceptive patients (Harper et al15 provides full description). The majority of contraceptive providers (85%) reported that they had never recommended the copper IUD for emergency contraception (Table 1). A total of 15% of clinicians had recommended the IUD for emergency contraception: 13% had recommended the method one to 10 times, and only 1.7% had recommended the method more than 10 times. Few demographic or professional characteristics were associated with clinician recommendation of the copper IUD for emergency contraception. Age, number of practice years, sex, and race or ethnicity were not associated.
Interestingly, there was little difference by specialty in having recommended a copper IUD for emergency contraception, and ob-gyns, despite their advanced clinical skill level in intrauterine contraception insertion, were no more likely than others to recommend it to their patients: 13% of ob-gyns, 15% of other physicians, 18% of advance practice clinicians in obstetrics-gynecology or women's health, and 12% of other advance practice clinicians (P=.237). However, clinicians in public clinics (19%) as compared with private offices (11%) were more likely to have recommended the copper IUD for emergency contraception to patients (P=.002), as were those with a larger contraceptive patient volume (P≤.001).
Sixty percent of clinicians reported they were very comfortable inserting the copper IUD, with large differences by specialty: 93% of ob-gyns, 39% of other physicians, 75% of advance practice clinicians in obstetrics-gynecology or women's health, and 39% of other advance practice clinicians (P≤.001). Comfort level in copper IUD insertion was significantly associated with recommending it for emergency contraception: 18% of clinicians who felt very comfortable with copper IUD insertions had recommended it for emergency contraception to patients compared with 7% of those with low comfort levels (P=.001). Although the number of IUDs inserted during residency or core training was not directly associated with recommending the copper IUD for emergency contraception, the level of training was strongly predictive of current comfort in insertions: 93% who inserted more than 50 IUDs during training felt very comfortable inserting copper IUDs, 67% who inserted less than 50, and 32% who did not insert any during residency or core training (P≤.001).
Most providers (85%) reported sufficient time to counsel patients on contraception and 92% believed their patients were receptive to learning about intrauterine contraception; however, there was no difference in having recommended the copper IUD to patients for emergency contraception by sufficient counseling time (P=.961) and beliefs about patient interest (P=.937). Surprisingly, clinicians who routinely counseled their patients on intrauterine contraception were no more likely to have discussed it with them as a method of emergency contraception than clinicians who counseled patients less frequently (P=.285). However, clinicians who reported they had sufficient experience to counsel patients on the copper IUD were significantly more likely to have recommended it for emergency contraception, although the proportion was still low (16% compared with 7%; P=.007). Providers who had a more evidence-based view of eligible intrauterine contraception candidates were significantly more likely to have recommended the copper IUD for emergency contraception (P≤.001). However, familiarity with method side effects and attributes surprisingly was not associated with greater recommendation of the IUD for emergency contraception (P=.50).
There were some clear structural obstacles to providing the copper IUD for emergency contraception, including cumbersome protocols and clinic flow challenges. The number of visits required for IUD insertion in most practices offering the method was high: 75% required two visits and 18% required three or more visits; only 7% offered insertions during one visit. Those few practices that offered intrauterine contraception during one visit were far more likely to have recommended the copper IUD for emergency contraception (34% compared with 15%; P=.002). Among those providers who offered patients intrauterine contraception, almost half reported they were hindered by availability of the IUD during the visit (46%) and 36% also reported they were hindered by scheduling difficulties. It was also still common practice among those offering IUDs to require women to be on their menses for an insertion (38%). Many tests were required as well: 80% of those providing IUDs always required a Pap test within the past year; 70% always required a Chlamydia test in the past 3 months for women older than 25 years of age and 84% always required the test for women 25 years or younger; and 38% always required a hemoglobin test in the past 3 months.
Results from multivariable logistic regression analysis of the factors associated with recommending the copper IUD for emergency contraception are presented in Table 2. The first model focusing on professional training and practice type showed that a high number of intrauterine contraception insertions during core training or residency and contraceptive patient volume were associated with recommending the copper IUD for emergency contraception, whereas private practice was negatively related. The second model included current intrauterine contraception competency and evidence-based knowledge, and showed that evidence-based views of eligible candidates for the copper IUD were the most significant factor, with odds of recommending emergency contraception twice as high for clinicians with expansive views of candidates. The level of expertise with copper IUD insertions was also significantly associated with recommending the copper IUD for emergency contraception. Copper IUD insertions skills, in turn, were significantly associated with intrauterine contraception training, the obstetrics-gynecology or women's health specialty, evidence-based knowledge of intrauterine contraception, and a higher contraceptive patient volume (data not shown).
These data showed that contraceptive providers infrequently recommend the copper IUD for emergency contraception to their patients. Although it is still not routine practice for contraceptive providers to offer patients intrauterine contraception as ongoing contraception, there are certain factors shown to be associated with provision of the most effective reversible contraceptives in previous research, including younger age, training as a physician, training during residency or core training, a specialty in obstetrics-gynecology or women's health or both, high contraceptive patient volume, a high level of knowledge of method attributes and side effects, and an expansive view of intrauterine contraception candidates.15,17,19 Whereas some of these factors were associated with having recommended the copper IUD for emergency contraception, some of our results were unexpected. The ob-gyns, who were the clinicians with the highest skill levels in contraception, were not any more likely than other clinicians to have recommended the copper IUD as emergency contraception, despite their extensive training in copper IUD insertions, nor were younger clinicians or those who frequently counseled patients on intrauterine contraception as contraception. These results indicate a need to emphasize the use of the copper IUD for emergency contraception in clinician training and education. Patient-centered and high-quality care for emergency contraception should include a discussion of the most effective method.
In terms of counseling women on side effects and what to expect, the information would be the same in the case of the copper IUD for emergency contraception. That is, for some women the copper IUD can have pain and cramping during insertion and then can entail heavier menstrual bleeding.20 There is a slightly increased risk of infection during insertion,21 a small risk of perforation,4,22 and a 2%–10% risk of expulsion in the first year, which is higher among adolescents and nulliparous women.23
Skill levels inserting the copper IUD were important for both general provision and for the purposes of emergency contraception.15 The most significant factor associated with recommendation of the IUD for emergency contraception, however, was evidence-based and expansive views of women who would be eligible for intrauterine contraception. One of the most important elements to include in educational efforts for clinicians, including those in the obstetrics-gynecology specialty, would be an emphasis on the wider range of candidates who qualify for use of intrauterine contraception according to the Centers for Disease Control medical eligibility criteria.14
Many young women are still not aware of the copper IUD and its high level of effectiveness, even as an ongoing method of contraception; however, when given the information, some women have expressed preference for the copper IUD over emergency contraceptive pills.12,13,24 Given the high efficacy of the copper IUD and its potential for lasting protection, it may be possible to reduce pregnancy rates, even with a modest proportion of women at risk for unintended pregnancy choosing this emergency contraception method. It is timely to include the copper IUD as emergency contraception in the larger context of increased professional attention to intrauterine contraception in the United States.25
A limitation of this survey was that the providers were asked whether they recommended the copper IUD for emergency contraception. It is possible that more providers have, in fact, offered their patients the method but would not see themselves as recommending it, because that would be directive.
Changes in clinical practice would be required to offer same-day provision of the copper IUD, which is not yet common practice. These data showed less than 10% of practices were offering same-day provision, which was consistent with other survey estimates.26 Multiple visit protocols for intrauterine contraception provision serve as a road block to using the copper IUD for emergency contraception. Other significant barriers to same-day provision, cost and contraceptive policies,26 should be ameliorated by the recent Institutes of Medicine Report on Women's Health27 and the decision of Health and Human Services to improve contraceptive coverage policies. The copper IUD is not cost-effective for one-time use for emergency contraception; it is an appropriate method for women also interested in a regular method of contraception. The method becomes cost-effective in 1 year, and by 5 years of use it is the most cost-effective contraceptive available.28
These data showed important missed opportunities among contraceptive providers, including highly trained ob-gyns, for offering women at risk for unintended pregnancy the most effective method available for emergency contraception, the copper IUD. An emphasis during clinician training on the use of the copper IUD for emergency contraception may help to address high unintended pregnancy rates. The study also showed the relevance of updating contraceptive providers on the evidence and more expansive current criteria for intrauterine contraception candidates as set out by Centers for Disease Control medical eligibility criteria.
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