Abstract
Background
The Centers for Disease Control’s U.S. Medical Eligibility Criteria for Contraceptive Use recommends that combined hormonal contraceptives (i.e., birth control pills, contraceptive patch, vaginal ring) should be avoided in women with specific medical conditions due to increased risk of cardiovascular events associated with estrogen use. Whether women with category 3 (theoretical or proven risk usually outweigh the advantages) or category 4 (unacceptable health risk) contraindications are appropriately avoiding estrogen-containing combined hormonal contraceptives is unknown.
Objective
We describe the prevalence of combined hormonal contraceptive use among a sample of reproductive age women with medical contraindications to estrogen use. Our hypothesis was that women with category 3 and 4 contraindications would use estrogen-containing contraception less often than women without medical contraindications. We also explore whether inappropriate estrogen-containing contraceptive use is related to contraceptive provider characteristics.
Study Design
Data are from the baseline survey of the MyNewOptions study, which included privately-insured women residing in Pennsylvania aged 18–40, who were sexually active and not intending pregnancy in the next year. Women were surveyed about their medical conditions, contraceptive use, and characteristics of their contraceptive provider. Women were considered to have a contraindication to combined hormonal contraceptives if they reported a category 3 or category 4 contraindication—hypertension, smokers over age 35, history of venous thromboembolism, diabetes with complications, coronary artery disease, systemic lupus erythematosus with antiphospholipid antibodies, breast cancer, or migraine headaches with aura. Chi-square tests for general association were used to compare combined hormonal contraceptives use, contraceptive health provider characteristics, and sociodemographic data in women with and without contraindications to estrogen use.
Results
The MyNewOptions baseline study sample included 987 adult women who were mostly young (46% were 18–25 years), white (94%), employed (70%), and married or cohabiting (54%). Thirteen percent (n=130) of the sample had a medical contraindication to estrogen-containing contraceptive use—migraine with aura (81%) was the most common contraindication, followed by smokers over age 35 (7%), hypertension (11%), history of venous thromboembolism (4%), and diabetes with complications (2%). High use of combined hormonal contraceptives was reported among the women with medical contraindications to estrogen at 39% (n=51). This was not statistically different from women without a medical contraindication (47%, p=0.1). Among the 130 women with a contraindication, whether they did or did not use an estrogen-containing contraceptive did not vary by education level, income, or weight category. With respect to their contraceptive prescribers, there were no differences in prescriber specialty, provider type, or clinic type comparing women using and not using an estrogen-containing contraceptive.
Conclusion
Among this study sample of reproductive age women, there was a high rate of combined hormonal contraceptive use in women with a medical contraindication to estrogen use. These women may be at increased risk for cardiovascular events. Processes need to be improved to ensure that women with medical contraindications to estrogen-containing contraception are being offered the safest and most effective methods, including long-acting reversible contraceptives, such as intrauterine devices and the contraceptive implant.
Keywords: combined hormonal contraception, medical contraindications
Introduction
Over 80% of women in the United States have ever used hormonal contraception.1 Hormonal contraception includes estrogen-progesterone combined hormonal contraception (CHC), which can provide effective protection against pregnancy with many non-contraceptive health benefits2 and can safely be used by most women. However, there are certain medical conditions that increase the risk of adverse events associated with CHC use, mostly related to cardiovascular complications. The prevalence of reproductive age women with medical contraindications to CHC has been reported at 2–16%.3, 4
The World Health Organization (WHO) Medical Eligibility Criteria for contraceptive use5 and the adapted Center for Disease Control (CDC) Medical Eligibility Criteria for contraceptive use6 provide evidence based guidelines for prescribing contraception to women with medical comorbidities. In the setting of various health conditions, these criteria classify CHC use as category 1 (no restrictions to method use), category 2 (advantages of method generally outweigh the theoretical or proven risks), category 3 (theoretical or proven risks usually outweigh the advantages for using the method), or category 4 (unacceptable health risk if the method is used). Previous studies report that 6–11% of current combined oral contraceptive users had at least one contraindication to CHC.4, 7
We describe the prevalence of CHC use among women with medical contraindications to estrogen use in a sample of reproductive age women. Our hypothesis was that women with category 3 or 4 contraindications to estrogen-containing contraception would be less likely to use CHC than women without a medical contraindication. We also explore whether inappropriate CHC use is related to contraceptive provider characteristics.
Materials and Methods
This analysis was performed using the baseline survey data from the MyNewOptions study, an ongoing randomized controlled trial to test an online reproductive life planning intervention for assisting privately-insured adult women with personalized contraceptive decision-making (ClinicalTrials.gov Identifier: NCT02100124). The sample included 987 female Highmark Health members in Pennsylvania between the ages of 18 and 40. Women were eligible for the study if they were sexually active, not intending pregnancy in the next 12 months, not surgically sterilized or with a partner who was surgically sterilized, had Internet access and a valid email address. Participants then completed a baseline survey that ascertained baseline demographics, current method of contraception, and their medical comorbidities. Randomization and online intervention occurred after completion of the baseline survey. Additional details regarding the study protocol have been published elsewhere.8 This study was approved by the Penn State Hershey Institutional Review Board under IRB protocol No. 44583EP with informed consent obtained online.
Contraceptive Method
The survey measured current contraceptive method by asking women to indicate the method of contraception used within the last month. If more than one choice was selected, participants were then asked “which method do you consider to be your primary method?” The outcome measure is current use of a CHC, which was defined as combined birth control pills (containing both estrogen and progestin), the contraceptive patch, and the vaginal ring. For women using birth control pills, the survey response choice was “birth control pills,” and did not specify combined pills or progestin-only pills. To make this distinction, pharmacy claims data were obtained from Highmark Health and used to determine whether the most recent pharmacy claim prior to the woman’s baseline survey was for combined or progestin-only oral contraceptive. All other contraceptives were considered non-estrogen contraception, which included male and female condoms, the medroxyprogesterone acetate injectable, intrauterine devices (IUD), diaphragm, cervical cap, contraceptive foam, jelly, cream or suppository, the sponge, contraceptive implant, rhythm or natural family planning, withdrawal, and no method of contraception.
Medical Contraindications to CHC
We identified study participants with the following category 3 (theoretical or proven risk usually outweigh the advantages) and category 4 (unacceptable health risk) contraindications to CHC, according to the CDC Summary Chart of U.S. Medical Eligibility Criteria for Contraceptive Use6: 1) hypertension (category 3 if adequately controlled or category 4 if poorly controlled), 2) smokers over the age of 35 (category 3 if <15 cigarettes/day or category 4 if ≥15 cigarettes/day), 3) history of venous thromboembolism (VTE) (category 3 if lower risk for recurrent VTE or category 4 if higher risk for recurrent VTE), 4) diabetes with complications (category 3 if microvascular complications or category 4 if vascular disease or diabetes >20 years), 5) coronary artery disease (category 4), 6) systemic lupus erythematosus with antiphospholipid antibodies (category 4), 7) breast cancer (category 3 if previous breast cancer with no evidence of disease for 5 years or category 4 for current breast cancer), and 8) migraine with aura (category 4). Health conditions were determined by a series of questions asking, “Has a doctor, nurse, or other health professional EVER told you that you had or have any of the following?” Smoking was assessed by asking “Do you now smoke cigarettes every day, some days, or not at all?” In several cases, our survey tool was unable to distinguish category 3 from category 4 contraindications. For example, women over the age of 35 who smoked every day were considered to have a contraindication, but we were unable to specify whether it was category 3 or 4 because the number of cigarettes smoked per day was not ascertained. Of note, not all 18 category 3 and 4 health conditions were ascertained by the survey, so if women in the sample had other category 3 and 4 contraindications (severe liver cirrhosis, gallbladder disease, liver tumors, peripartum cardiomyopathy, organ transplant, thrombogenic mutations, and valvular heart disease) they may have been misclassified.
Contraceptive Provider Characteristics
Contraceptive provider characteristics were determined by a series of questions where the respondent was asked about “the most recent health care visit where you received any contraceptive or women’s health care services.” The clinic type (private office versus other clinic), specialty (Obstetrics and Gynecology versus other specialties), and provider type (physician versus non-physician provider) where the contraceptive or women’s health care services occurred were recorded.
Statistical Analysis
All variables were summarized with frequencies and percentages for categorical variables or with means, medians, and standard deviations for continuous variables prior to any analysis. Chi-square tests for general association, with Fisher exact tests substituted as needed, were used to compare CHC use, contraceptive health provider characteristics, and sociodemographics between women with and without contraindications to estrogen. This same approach was then applied to only the subgroup of 130 women with contraindications to CHC making bivariate comparisons of health provider characteristics and sociodemographics between women with CHC use and women without CHC use. All analyses were performed using SAS version 9.4 (SAS Institute, Cary, NC).
Results
Characteristics of the study sample (n=987) are shown in Table 1. Of the total sample, 13.2% (n=130) of women had a contraindication to CHC. The most common contraindication was migraine with aura (n=105, 80.7%). Of the remaining 25 women with a contraindication, conditions included age ≥ 35 smokers (n=9, 6.9%), hypertension (n=14, 10.8%), history of venous thromboembolism (n=5, 3.9 %), and diabetes with complications (n=2, 1.5%). Five women had two medical conditions that were contraindications to CHC which included 2 patients with migraine with aura and hypertension, 2 smokers with hypertension, and 1 smoker with history of VTE. Results of the bivariate analysis comparing women with and without contraindications to CHC are summarized in Table 1. There were no statistically significant differences between women with and without contraindication to CHC with regards to race, education, income, or contraceptive provider characteristics. Women with contraindication to CHC were more likely to be overweight and obese compared with women without contraindications to CHC use (27.9% vs. 21.6% and 29.5% vs. 18.3% respectively, p<0.001). Mean age of women with contraindications was 28.85 ± 6.23 years and the mean age of women without contraindications was 26.88 ± 5.92 years. Only 12 (1.2%) women indicated Hispanic ethnicity.
Table 1.
Characteristics of reproductive age women with and without contraindications to CHC use
| Characteristic | Total (N=987) |
Women with contraindication to CHC (n=130) |
Women without contraindication to CHC (n=857) |
P-valuea |
|---|---|---|---|---|
|
| ||||
| Current CHC use | 0.097 | |||
| Yes | 454 (46.0) | 51 (39.2) | 403 (47.0) | |
| No | 533 (54.0) | 79 (60.8) | 454 (53.0) | |
|
| ||||
| Non-white race | 0.061 | |||
| Yes | 50 (5.1) | 11 (8.5) | 39 (4.6) | |
| No | 931 (94.9) | 119 (91.5) | 812 (95.4) | |
|
| ||||
| Education | 0.803 | |||
| HS grad or less | 70 (7.1) | 9 (7.0) | 61 (7.1) | |
| Some college | 318 (32.4) | 45 (34.9) | 273 (32.0) | |
| College grad | 595 (60.5) | 75 (58.1) | 520 (60.9) | |
|
| ||||
| Income | 0.691 | |||
| <$25,000 | 133 (13.9) | 14 (10.9) | 119 (14.4) | |
| $25,000–$49,999 | 243 (25.4) | 32 (25.0) | 211 (25.5) | |
| $50,000–$74,999 | 233 (24.4) | 31 (24.2) | 202 (24.4) | |
| ≥$75,000 | 347 (36.3) | 51 (39.8) | 296 (35.8) | |
|
| ||||
| Body Mass Index (kg/m2) | <0.001 | |||
| Underweight (<18.5) | 27 (2.8) | 5 (3.9) | 22 (2.6) | |
| Normal (18.5–<25) | 542 (55.1) | 50 (38.8) | 492 (57.6) | |
| Overweight (25–<30) | 220 (22.4) | 36 (27.9) | 184 (21.6) | |
| Obese (≥30) | 194 (19.7) | 38 (29.5) | 156 (18.3) | |
|
| ||||
| Contraception managed by OB/Gyn | 0.709 | |||
| Yes | 672 (82.0) | 92 (80.7) | 580 (82.2) | |
| No | 148 (18.0) | 22 (19.3) | 126 (17.8) | |
|
| ||||
| Contraception managed by physician | 0.852 | |||
| Yes | 566 (71.0) | 78 (70.3) | 488 (71.1) | |
| No | 231 (29.0) | 33 (29.7) | 198 (28.9) | |
|
| ||||
| Contraception managed by private doctors office | 0.278 | |||
| Yes | 826 (87.5) | 114 (90.5) | 712 (87.0) | |
| No | 118 (12.5) | 12 (9.5) | 106 (13.0) | |
P-value from Chi-square test for general association, exact test used as needed
Among the 130 women with a contraindication to CHC, 39.2% (n=51) were using CHC. This was not statistically different from women without a contraindication (47.0%, p=0.1). The bivariate analysis describing CHC use among the subset of women with contraindications to CHC (n=130) are summarized in Table 2. CHC use did not differ by education level, income, or weight category. There were also no differences in contraceptive provider specialty, provider type, or clinic type. CHC non-users were more likely to be non-white than CHC-users (12.7% vs. 2.0% p=0.049). Mean age of CHC users was 27.51 ± 6.02 years and non-users 29.71 ± 6.25 years. 21.6% (n=11) users and 27.9% (n=22) of non- users were ≥ 35 (p=0.422).
Table 2.
Characteristics associated with CHC use among women with known contraindications to CHC use
| Characteristic | Total (N=130) |
CHC Users (N=51) |
Non-CHC Users (N=79) |
P- valuea |
|---|---|---|---|---|
|
| ||||
| Medical Comorbidity | ||||
| Migraine with aura | 105 (80.7) | 43 (84.3) | 62 (79.5) | 0.551 |
| Age ≥ 35 smokers | 9 (6.9) | 2 (3.9) | 7 (8.9) | 0.321 |
| Hypertension | 14 (10.8) | 3 (5.9) | 11 (13.9) | 0.149 |
| Otherb | 7 (5.4) | 3 (2.3) | 4 (3.1) | 1.000 |
|
| ||||
| Age | 0.422 | |||
| ≥35 years | 33 (25.4) | 11 (21.6) | 22 (27.9) | |
| <35 years | 97 (74.6) | 40 (80.4) | 57 (72.15) | |
|
| ||||
| Non-white race | 0.049 | |||
| Yes | 11 (8.5) | 1 (2.0) | 10 (12.7) | |
| No | 119 (91.5) | 50 (98.0) | 69 (87.3) | |
|
| ||||
| Education | 0.155 | |||
| HS grad or less | 9 (7.0) | 1 (2.0) | 8 (10.3) | |
| Some college | 45 (34.9) | 17 (33.3) | 28 (35.9) | |
| College grad | 75 (58.1) | 33 (64.7) | 42 (53.9) | |
|
| ||||
| Income | 0.470 | |||
| <$25,000 | 14 (10.9) | 6 (11.8) | 8 (10.4) | |
| $25,000–$49,999 | 32 (25.0) | 9 (17.7) | 23 (29.9) | |
| $50,000–$74,999 | 31 (24.2) | 13 (25.5) | 18 (23.4) | |
| ≥$75,000 | 51 (39.8) | 23 (45.1) | 28 (36.4) | |
|
| ||||
| Body Mass Index (kg/m2) | 0.394 | |||
| Underweight (<18.5) | 5 (3.9) | 3 (5.9) | 2 (2.6) | |
| Normal (18.5–<25) | 50 (38.8) | 23 (45.1) | 27 (34.6) | |
| Overweight (25–<30) | 36 (27.9) | 11 (21.6) | 25 (32.1) | |
| Obese (≥30) | 38 (29.5) | 14 (27.5) | 24 (30.8) | |
|
| ||||
| Contraception managed by OB/Gyn | 0.723 | |||
| Yes | 92 (80.7) | 38 (79.2) | 54 (81.8) | |
| No | 22 (19.3) | 10 (20.8) | 12 (18.2) | |
|
| ||||
| Contraception managed by physician | 0.891 | |||
| Yes | 78 (70.3) | 32 (69.6) | 46 (70.8) | |
| No | 33 (29.7) | 14 (30.4) | 19 (29.2) | |
|
| ||||
| Contraception managed by private doctors office | 0.358 | |||
| Yes | 114 (90.5) | 48 (94.1) | 66 (88.0) | |
| No | 12 (9.5) | 3 (5.9) | 9 (12.0) | |
P-value from Chi-square test for general association, exact test used as needed
Other includes history of venous thromboembolism, diabetes with complications. These groups were combined due to small numbers.
The largest group of women with contraindications to CHC were those with migraine with aura, therefore we performed a post-hoc analysis of just women with migraines to determine if women with and without aura had differences in contraceptive use. Of the total sample, 23.4% (n=231) reported that they suffered from migraine headaches, among whom 45.5% (n=105) reported experiencing aura, which was ascertained by the question, “Do you get migraine auras? Symptoms of migraine aura can include changes in your vision (blind spots, seeing flashing lights, or zigzag lines), feeling prickling skin, having difficulty speaking, or seeing things that aren’t there (hallucinations).” There was no statistically significant difference in CHC use between women with migraine with aura and those without (40.9% vs. 46.8%, p=0.371).
Comment
Among this study sample of privately insured reproductive age women, there was a high rate (39.2%) of CHC use among women with a medical contraindication to estrogen use. In fact, they were statistically no less likely to be using CHC than women without a medical contraindication to estrogen use. Almost half of women with migraine with aura, an “unacceptable health risk,” were using CHC in our sample. Previous literature has shown lower rates of CHC use among women with contraindications compared to those without, although the association was no longer significant when controlling for sociodemographic characteristics.3 Among CHC users, 11.23% had a contraindication to estrogen, similar to previously published data.4, 7 There were no differences in contraceptive provider or clinic characteristic between those using CHC and those who were not.
The concerns about CHC use when contraindications are present center on cardiovascular risk. Although CHC has consistently been associated with an increased relative risk of venous thromboembolism,9 the overall absolute risk remains low, especially compared to the risk associated with pregnancy. A recent Cochrane Review suggested there is no increased risk of arterial thrombosis including myocardial infarction or ischemic stroke, in average risk oral contraceptive users with estrogen formulations <50 µg.10 However, for women with certain medical comorbidities, estrogen containing contraception, or CHC, increases their risk of these cardiovascular complications2 and should be avoided. Our study was designed using the CDC Medical Eligibility Criteria, but there are women with increased cardiovascular risk due to multiple risk factors such as obese women who smoke or have migraines, for which this guideline is less clear. While not addressed in our study, this group would be of interest in future research. Processes need to be improved to ensure that women with medical contraindications are being offered the safest and most effective non-estrogen containing methods, including LARCs (long acting reversible contraceptives). LARCs, which include IUDs and the contraceptive implant, are the most effective reversible contraceptive methods currently available.
Reducing unintended pregnancy by increasing access to contraception has led to interest in over-the-counter oral contraception. While opponents have argued that requiring a prescription allows providers to assess women for contraindications to CHC, our study results suggest that the current process is not effectively helping women obtain the safest methods for their individual characteristics. Previous studies have shown women are able to accurately self-screen for contraindications to estrogen with a medical checklist.11 In a recent survey of U.S women at risk for pregnancy, more than 60% of respondents were in favor of over-the counter access to OCPs, and almost one third of women not currently using contraception said they were likely to start using OCPs if available over-the-counter.12
The largest contraindication category in our study sample was migraine with aura, which is classified as a category 4, or “unacceptable health risk.” In our study, almost half of women with migraines reported having migraines with aura, and almost half of women with migraine with aura were using CHC. Research has suggested that migraine headaches are associated with an increased risk of ischemic stroke,13, 14, 15 with an increased risk in women with migraine with aura when compared to those with migraine without aura.16, 17, 18 The association between ischemic stroke and migraine also appears stronger in younger women, particularly those under 34 to 45.15, 16 Use of hormonal contraception, particularly estrogen containing, is independently associated with an increased risk of ischemic stroke.19, 20 This risk increases with age, smoking, and other medical comorbidities that increase the risk of ischemic stroke.21 Studies suggest there is an increased risk among migraine patients who are using CHC.14, 17, 18, 22, 23 although the risk of ischemic stroke may be lower with low-dose estrogen preparations.20, 22
One limitation of our study is we were not able to distinguish whether some women had category 3 (theoretical or proven risk usually outweigh the advantages) or category 4 (unacceptable health risk) contraindications to CHC. For example, we ascertained if women had hypertension, but did not have information on how well it was controlled—adequately controlled hypertension is category 3 and poorly controlled hypertension is category 4. Similarly, we included women over age 35 who reported smoking every day, but do not know if they smoked <15 cigarettes/day (category 3) or if ≥15 cigarettes/day (category 4). Additionally, patients who reported smoking some days may influence prescribing patterns, which was not addressed in our study. The high use of CHC in women with contraindications could be a result of patient and provider acceptance of the increased associated risk with CHC in favor of the contraceptive and non-contraceptive benefits associated with CHC in women with category 3 contraindications. However, less than 20% of patients could potentially have had a category 3 contraindication; therefore most women with contraindications in our study were using CHC despite “unacceptable health risk”. Another possible explanation for the similar rates of CHC use could be lack of knowledge of contraindications to CHC by both the prescriber and the patient. Previous research has demonstrated over 30% of surveyed Obstetrician/Gynecologists and Family Physicians disagreed with a statement that “migraine with aura should not be prescribed” CHC.24 The CDC and WHO rate this a category 4, and this was the largest group in our study at over 80%. This highlights the need for adequate provider education on appropriate patient selection for the varying contraceptive methods. The choice to use CHC when contraindicated could also be related to cost considerations. Although our study was conducted in a sample of privately insured women after the Affordable Care Act’s (ACA) contraceptive coverage mandate, we have previously reported that awareness of contraceptive coverage in this sample is low.25 Another possible explanation for our negative finding is a result of type II error. A post-hoc power analysis results in only 38% power for a two-sided Chi-square test using a significance level of 0.05. However, our study still highlights a large number of women with contraindications to estrogen using CHC, who could potentially benefit from safer, more effective methods of contraception.
A limitation of our study is that we relied on self-report of medical comorbidities, and did not verify through medical records. Previous studies, however, have shown strong concordance between physician screening and patient reporting of medical comorbidities for contraindications to CHC, 90% or higher for many of the conditions we studied.26 In our study, there were higher numbers of migraine with aura than in previous studies. This could also be a result of self-report of medical conditions, or selection bias of patients who chose to participate in our study. Previous research has suggested that patient report of migraine also has a high degree, >87%, of agreement with International Classification of Headache Disorders based migraine classification27, but there is limited data regarding the agreement of self-reported aura. Future research on this topic should include access to medical records to confirm the diagnosis. Our study was survey based, and although the risk of social desirability bias is minimized with anonymous electronic surveys, this could still influence patient reporting.
Many factors contribute to the decision on contraceptive method. The decision may be based on safety, efficacy, perceived pregnancy risk, desire for future pregnancy, and method.28, 29, 30 The decision also depends on access, availability, and cost of a particular method.31 The majority of women in our study were college graduates, over one third reported an income ≥$75,000, more than half were normal weight or underweight, and there were very few Hispanic women in the study. The decision to use CHC for these women may not be generalizable to all populations. However, expansion of contraceptive benefits through the ACA can provide the opportunity for women with contraindications to estrogen to choose a safer, more effective method without cost concerns. In our study, inappropriate CHC use was not related to contraceptive provider characteristics, suggesting contraceptive providers of all types and specialties can play a greater role in identifying contraceptive contraindications and offering safer alternatives.
Acknowledgments
R.S.L. is a consultant for Bayer, Takeda Pharmaceutical Company, Lupin Pharmaceuticals and has other research funded by Astra-Zeneca, Ferring Pharmaceuticals.
This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Program Award (CD-1304-6117). The funding source had no role in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.
This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Program Award (CD-1304-6117). All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.
Study data were collected and managed using REDCap electronic data capture tools hosted at the Penn State Milton S. Hershey Medical Center and College of Medicine. REDCap is supported by the Penn State Clinical & Translational Science Institute, Pennsylvania State University CTSI, NIH/NCATS Grant Number UL1 TR000127. The contents are solely the responsibility of the authors and do not necessarily represent the official views of NIH/NCATS.
The authors thank Highmark Health for their assistance with participant recruitment. The findings and conclusions presented are solely those of the authors and do not represent the views of Highmark Health.
Footnotes
Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Disclosure: The remaining authors report no conflicts of interest.
ClinicalTrials.gov Identifier: NCT02100124
References
- 1.Daniels K, Mosher WD. Contraceptive methods women have ever used: United States, 1982–2010. Natl Health Stat Report. 2013:1–15. [PubMed] [Google Scholar]
- 2.Use of hormonal contraception in women with coexisting medical conditions. ACOG Practice Bulletin No. 73. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2006;107:1453–72. doi: 10.1097/00006250-200606000-00055. [DOI] [PubMed] [Google Scholar]
- 3.Shortridge E, Miller K. Contraindications to oral contraceptive use among women in the United States, 1999–2001. Contraception. 2007;75:355–60. doi: 10.1016/j.contraception.2006.12.022. [DOI] [PubMed] [Google Scholar]
- 4.Xu H, Eisenberg DL, Madden T, Secura GM, Peipert JF. Medical contraindications in women seeking combined hormonal contraception. Am J Obstet Gynecol. 2014;210:210.e1–5. doi: 10.1016/j.ajog.2013.11.023. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.World Health Organization. Reproductive Health and Research. Medical eligibility criteria for contraceptive use 4th edition. Geneva: Department of Reproductive health and Research, World Health Organization; 2010. [Google Scholar]
- 6.Centers for Disease Control and Prevention. U.S. Medical Eligibility Criteria for Contraceptive Use, 2010: Adapted from the World Health Organization Medical Eligbibility Criteria for Contraceptive Use, 4th Edition. MMWR Morb Mortal Wkly Rep. 2010;59(RRO4):1-. [Google Scholar]
- 7.Grossman D, White K, Hopkins K, Amastae J, Shedlin M, Potter JE. Contraindications to combined oral contraceptives among over-the-counter compared with prescription users. Obstet Gynecol. 2011;117:558–65. doi: 10.1097/AOG.0b013e31820b0244. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.Chuang CH, Velott DL, Weisman CS, Sciamanna CN, Legro RS, Chincilli VM, et al. Reducing Unintended Pregnancies Through Web-Based Reproductive Life Planning and Contraceptive Action Planning among Privately Insured Women: Study Protocol for the MyNewOptions Randomized, Controlled Trial. Womens Health Issues. 2015 doi: 10.1016/j.whi.2015.06.010. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9.Food and Drug Administration. Combined hormonal contraceptives (CHC) and the risk if cardiovascular disease endpoints. Silver Spring (MD): 2011. [Google Scholar]
- 10.Roach RE, Helmerhorst FM, Lijfering WM, Stijnen T, Algra A, Dekkers OM. Combined oral contraceptives: the risk of myocardial infarction and ischemic stroke. Cochrane Database Syst Rev. 2015;8:Cd011054. doi: 10.1002/14651858.CD011054.pub2. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.Grossman D, Fernandez L, Hopkins K, Amastae J, Garcia SG, Potter JE. Accuracy of self-screening for contraindications to combined oral contraceptive use. Obstet Gynecol. 2008;112:572–8. doi: 10.1097/AOG.0b013e31818345f0. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.Grossman D, Grindlay K, Li R, Potter JE, Trussell J, Blanchard K. Interest in over-the-counter access to oral contraceptives among women in the United States. Contraception. 2013;88:544–52. doi: 10.1016/j.contraception.2013.04.005. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.Nightingale AL, Farmer RD. Ischemic stroke in young women: a nested case-control study using the UK General Practice Research Database. Stroke. 2004;35:1574–8. doi: 10.1161/01.STR.0000129789.58837.e4. [DOI] [PubMed] [Google Scholar]
- 14.Lidegaard O. Oral contraceptives, pregnancy and the risk of cerebral thromboembolism: the influence of diabetes, hypertension, migraine and previous thrombotic disease. Br J Obstet Gynaecol. 1995;102:153–9. doi: 10.1111/j.1471-0528.1995.tb09070.x. [DOI] [PubMed] [Google Scholar]
- 15.Carolei A, Marini C, De Matteis G. History of migraine and risk of cerebral ischaemia in young adults. The Italian National Research Council Study Group on Stroke in the Young. Lancet. 1996;347:1503–6. doi: 10.1016/s0140-6736(96)90669-8. [DOI] [PubMed] [Google Scholar]
- 16.Schürks M, Rist PM, Bigal ME, Buring JE, Lipton RB, Kurth T. Migraine and cardiovascular disease: systematic review and meta-analysis. BMJ. 2009;339:b3914. doi: 10.1136/bmj.b3914. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 17.Tzourio C, Tehindrazanarivelo A, Iglésias S, Alpérovitch A, Chedru F, d’Angléjan-Chatillon J, et al. Case-control study of migraine and risk of ischaemic stroke in young women. BMJ. 1995;310:830–3. doi: 10.1136/bmj.310.6983.830. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 18.Etminan M, Takkouche B, Isorna FC, Samii A. Risk of ischaemic stroke in people with migraine: systematic review and meta-analysis of observational studies. BMJ. 2005;330:63. doi: 10.1136/bmj.38302.504063.8F. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19.Lidegaard O. Oral contraception and risk of a cerebral thromboembolic attack: results of a case-control study. BMJ. 1993;306:956–63. doi: 10.1136/bmj.306.6883.956. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20.Gillum LA, Mamidipudi SK, Johnston SC. Ischemic stroke risk with oral contraceptives: A meta-analysis. JAMA. 2000;284:72–8. doi: 10.1001/jama.284.1.72. [DOI] [PubMed] [Google Scholar]
- 21.Bushnell C, McCullough L. Stroke prevention in women: synopsis of the 2014 American Heart Association/American Stroke Association guideline. Ann Intern Med. 2014;160:853–7. doi: 10.7326/M14-0762. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 22.Schwartz SM, Petitti DB, Siscovick DS, Longstreth WT, Sidney S, Raghuanathan TE, et al. Stroke and use of low-dose oral contraceptives in young women: a pooled analysis of two US studies. Stroke. 1998;29:2277–84. doi: 10.1161/01.str.29.11.2277. [DOI] [PubMed] [Google Scholar]
- 23.Chang CL, Donaghy M, Poulter N. Migraine and stroke in young women: case-control study. The World Health Organisation Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. BMJ. 1999;318:13–8. doi: 10.1136/bmj.318.7175.13. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 24.Dehlendorf C, Levy K, Ruskin R, Steinauer J. Health care providers' knowledge about contraceptive evidence: a barrier to quality family planning care? Contraception. 2010;81:292–8. doi: 10.1016/j.contraception.2009.11.006. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 25.Chuang CH, Mitchell JL, Velott DL, Legro RS, Lehman EB, Confer L, et al. Women’s Awareness of Their Contraceptive Benefits Under the Patient Protection and Affordable Care Act. American Journal of Public Health. 2015;105:S713–S15. doi: 10.2105/AJPH.2015.302829. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 26.Shotorbani S, Miller L, Blough DK, Gardner J. Agreement between women's and providers' assessment of hormonal contraceptive risk factors. Contraception. 2006;73:501–506. doi: 10.1016/j.contraception.2005.12.001. [DOI] [PubMed] [Google Scholar]
- 27.Schürks M, Buring JE, Kurth T. Agreement of self-reported migraine with ICHD-II criteria in the Women's Health Study. Cephalalgia. 2009;29:1086–90. doi: 10.1111/j.1468-2982.2008.01835.x. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 28.Cepuliene R, Sveikatiene R, Gutauskas K, Vanagiene V. Factors influencing women's preference to select a combined hormonal contraceptive method: a cross-sectional survey in Lithuania. Medicina (Kaunas) 2012;48:424–30. [PubMed] [Google Scholar]
- 29.Egarter C, Frey Tirri B, Bitzer J, Kaminskyy V, Oddens BJ, Prilepskaya V, et al. Women's perceptions and reasons for choosing the pill, patch, or ring in the CHOICE study: a cross-sectional survey of contraceptive method selection after counseling. BMC Womens Health. 2013;13:9. doi: 10.1186/1472-6874-13-9. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 30.Frost JJ, Darroch JE. Factors associated with contraceptive choice and inconsistent method use, United States, 2004. Perpect Sec Reprod Health. 2008;40:94–104. doi: 10.1363/4009408. [DOI] [PubMed] [Google Scholar]
- 31.Weisman CS, Lehman EB, Legro RS, Velott DL, Chuang CH. How do pregnancy intentions affect contraceptive choices when cost is not a factor? A study of privately insured women. Contraception. 2015 doi: 10.1016/j.contraception.2015.05.007. [DOI] [PubMed] [Google Scholar]