Medicaid savings from the Contraceptive CHOICE Project: a cost-savings analysis.

BACKGROUND: Forty-five percent of births in the United States are unintended, and the costs of unintended pregnancy and birth are substantial. Clinical and policy interventions that increase access to the most effective reversible contraceptive methods (intrauterine devices and contraceptive implants) have potential to generate significant cost savings. Evidence of cost savings for these interventions is needed. OBJECTIVE: The purpose of this study was to conduct a cost-savings analysis of the Contraceptive CHOICE Project, which provided counseling and no-cost contraception, to demonstrate the value of investment in enhanced contraceptive care to the Missouri Medicaid program. STUDY DESIGN: The Contraceptive CHOICE Project was a prospective cohort study of 9256 reproductive-age women who were enrolled between 2007 and 2011. Study follow-up was completed October 2013. This analysis includes 5061 Contraceptive CHOICE Project participants who were current Missouri Medicaid beneficiaries or were uninsured and reported household incomes <201% of the federal poverty line. We created a simulated comparison group of women who were receiving care through the Missouri Title X program and modeled the contraception and pregnancy outcomes that would have occurred in the absence of the Contraceptive CHOICE Project. Data about contraceptive use for the comparison group (N=5061) were obtained from the Missouri Title X program and adjusted based on age, race, ethnicity, and income. To make an accurate comparison that would account for the difference in the 2 populations, we used our simulation model to estimate total Contraceptive CHOICE Project costs and total comparison group costs. We reported all costs in 2013 dollars to account for inflation. RESULTS: Among the Contraceptive CHOICE Project participants who were included, the uptake of intrauterine devices and implants was 76.1% compared with 4.8% among the comparison group. The estimated contraceptive cost for the simulated Contraceptive CHOICE Project group was $4.0 million vs $2.3 million for the comparison group. The estimated numbers of unintended pregnancies and births averted among the simulated Contraceptive CHOICE Project group compared with the comparison group were 927 and 483, respectively, which represented a savings in pregnancy and maternity care of $6.7 million. We estimated that the total cost savings for the state of Missouri attributable to the Contraceptive CHOICE Project was $5.0 million (40.7%) over the project duration. CONCLUSION: A program providing counseling and no-cost contraception yields substantial cost savings because of the increased uptake of highly effective contraception and consequent averted unintended pregnancy and birth.

Provision of no-cost, long-acting contraception and teenage pregnancy.

BACKGROUND: The rate of teenage pregnancy in the United States is higher than in other developed nations. Teenage births result in substantial costs, including public assistance, health care costs, and income losses due to lower educational attainment and reduced earning potential. METHODS: The Contraceptive CHOICE Project was a large prospective cohort study designed to promote the use of long-acting, reversible contraceptive (LARC) methods to reduce unintended pregnancy in the St. Louis region. Participants were educated about reversible contraception, with an emphasis on the benefits of LARC methods, were provided with their choice of reversible contraception at no cost, and were followed for 2 to 3 years. We analyzed pregnancy, birth, and induced-abortion rates among teenage girls and women 15 to 19 years of age in this cohort and compared them with those observed nationally among U.S. teens in the same age group. RESULTS: Of the 1404 teenage girls and women enrolled in CHOICE, 72% chose an intrauterine device or implant (LARC methods); the remaining 28% chose another method. During the 2008-2013 period, the mean annual rates of pregnancy, birth, and abortion among CHOICE participants were 34.0, 19.4, and 9.7 per 1000 teens, respectively. In comparison, rates of pregnancy, birth, and abortion among sexually experienced U.S. teens in 2008 were 158.5, 94.0, and 41.5 per 1000, respectively. CONCLUSIONS: Teenage girls and women who were provided contraception at no cost and educated about reversible contraception and the benefits of LARC methods had rates of pregnancy, birth, and abortion that were much lower than the national rates for sexually experienced teens. (Funded by the Susan Thompson Buffett Foundation and others.).

Risk of unintended pregnancy based on intended compared to actual contraceptive use.

BACKGROUND: After initiating a new contraceptive method, the provider has little control of how or whether that method is used. OBJECTIVE: We sought to compare unintended pregnancy rates by the initial chosen contraceptive method after counseling to traditional contraceptive effectiveness in the same study population. STUDY DESIGN: The Contraceptive CHOICE Project provided reversible contraception to 9252 women at no cost during 2-3 years of follow-up. We performed 2 analyses of contraceptive efficacy in this prospective cohort: (1) intent-to-use (ITU), grouping participants based on their chosen method at enrollment; and (2) as-used, categorizing participant time according to the method used. In ITU analysis, switching of methods and method continuation were not considered, as we wanted to assess outcomes based on the method chosen at baseline. We used Cox proportional hazards models to compare rates of unintended pregnancy. RESULTS: During 20,017 person-years, we identified 615 unintended pregnancies. In ITU analysis, pregnancy rates were 5.3, 5.5, 2.0, 1.7, and 1.9 per 100 person-years for women initiating oral, injectable, implantable, copper, and hormonal intrauterine contraception (IUC) at baseline, respectively. The adjusted hazard ratio for injectable contraception compared to hormonal IUC was 2.4 (95% confidence interval, 1.8-3.3). Delaying initiation of IUC or implantable contraception increased unintended pregnancies by 60% (adjusted hazard ratio, 1.6; 95% confidence interval, 1.2-2.0). In as-used analysis, pregnancy rates were 6.7, 1.6, 0.2, 0.6, and 0.2 per 100 person-years for women using oral, injectable, implantable, copper, and hormonal IUC, respectively. CONCLUSION: Although highly effective in the as-used analysis, women initially choosing injectable contraception had pregnancy rates similar to oral contraception and significantly worse than IUC or implantable contraception. Despite switching and discontinuation, women choosing an IUC or implantable contraception at baseline were much less likely to have an unintended pregnancy compared to those selecting other methods.

Effectiveness of long-acting reversible contraception.

BACKGROUND: The rate of unintended pregnancy in the United States is much higher than in other developed nations. Approximately half of unintended pregnancies are due to contraceptive failure, largely owing to inconsistent or incorrect use. METHODS: We designed a large prospective cohort study to promote the use of long-acting reversible contraceptive methods as a means of reducing unintended pregnancies in our region. Participants were provided with reversible contraception of their choice at no cost. We compared the rate of failure of long-acting reversible contraception (intrauterine devices [IUDs] and implants) with other commonly prescribed contraceptive methods (oral contraceptive pills, transdermal patch, contraceptive vaginal ring, and depot medroxyprogesterone acetate [DMPA] injection) in the overall cohort and in groups stratified according to age (less than 21 years of age vs. 21 years or older). RESULTS: Among the 7486 participants included in this analysis, we identified 334 unintended pregnancies. The contraceptive failure rate among participants using pills, patch, or ring was 4.55 per 100 participant-years, as compared with 0.27 among participants using long-acting reversible contraception (hazard ratio after adjustment for age, educational level, and history with respect to unintended pregnancy, 21.8; 95% confidence interval, 13.7 to 34.9). Among participants who used pills, patch, or ring, those who were less than 21 years of age had a risk of unintended pregnancy that was almost twice as high as the risk among older participants. Rates of unintended pregnancy were similarly low among participants using DMPA injection and those using an IUD or implant, regardless of age. CONCLUSIONS: The effectiveness of long-acting reversible contraception is superior to that of contraceptive pills, patch, or ring and is not altered in adolescents and young women. (Funded by the Susan Thompson Buffet Foundation.).

Three-year continuation of reversible contraception.

OBJECTIVE: The objective of this analysis was to estimate the 3-year continuation rates of long-acting reversible contraceptive (LARC) methods and to compare these rates to non-LARC methods. STUDY DESIGN: The Contraceptive CHOICE Project (CHOICE) was a prospective cohort study that followed 9256 participants with telephone surveys at 3 and 6 months, then every 6 months for 2-3 years. We estimated 3-year continuation rates of baseline methods that were chosen at enrollment. The LARC methods include the 52-mg levonorgestrel intrauterine device; the copper intrauterine device, and the subdermal implant). These were then compared to rates to non-LARC hormonal methods (depot medroxyprogesterone acetate, oral contraceptive pills, contraceptive patch, and vaginal ring). Eligibility criteria for this analysis included participants who started their baseline chosen method by the 3-month survey. Participants who discontinued their method to attempt conception were censored. We used a Cox proportional hazard model to adjust for confounding and to estimate the hazard ratio for risk of discontinuation. RESULTS: Our analytic sample consisted of 4708 CHOICE participants who met inclusion criteria. Three-year continuation rates were 69.8% for users of the levonorgestrel intrauterine device, 69.7% for copper intrauterine device users, and 56.2% for implant users. At 3 years, continuation was 67.2% among LARC users and 31.0% among non-LARC users (P < .001). After adjustment for age, race, education, socioeconomic status, parity, and history of sexually transmitted infection, the hazard ratio for risk of discontinuation was 3-fold higher among non-LARC method users than LARC users (adjusted hazard ratio, 3.08; 95% confidence interval, 2.80-3.39). CONCLUSION: Three-year continuation of the 2 intrauterine devices approached 70%. Continuation of LARC methods was significantly higher than non-LARC methods.

Contraceptive continuation in Hispanic women.

OBJECTIVE: The purpose of this study was to examine the effect of Hispanic ethnicity on the continuation and satisfaction of reversible contraceptive methods. STUDY DESIGN: We analyzed 12 months of data that were collected from 7913 participants in the Contraceptive CHOICE Project. Kaplan-Meier survival curves were used to estimate continuation, and Cox proportional hazard models were used to estimate the risk of discontinuation. RESULTS: Hispanic women were more likely to choose a long-acting reversible contraceptive (LARC) method compared with non-Hispanic black and non-Hispanic white women (80%, 73%, and 75%, respectively; P < .05). The 12-month continuation rates were higher for LARC methods than combined hormonal methods for all race/ethnicity (Hispanic women, 87% vs 40%; non-Hispanic black women, 85% vs 46%; non-Hispanic white women, 87% vs 56%). There was no statistical difference in discontinuation of LARC methods at 12 months. Eighty percent of LARC users reported high satisfaction levels at 12 months, regardless of race/ethnicity. CONCLUSION: Hispanic women in the Contraceptive CHOICE Project experienced high continuation and satisfaction for LARC methods, similar to women of other ethnicities.

Association of short-term bleeding and cramping patterns with long-acting reversible contraceptive method satisfaction.

OBJECTIVE: We sought to examine the short-term (3- and 6-month), self-reported bleeding and cramping patterns with intrauterine devices (IUDs) and the contraceptive implant, and the association of these symptoms with method satisfaction. STUDY DESIGN: We analyzed 3- and 6-month survey data from IUD and implant users in the Contraceptive CHOICE Project, a prospective cohort study. Participants who received a long-acting reversible contraceptive (LARC) method (levonorgestrel-releasing intrauterine system [LNG-IUS], copper IUD, or the etonogestrel implant) and completed their 3- and 6-month surveys were included. Univariable and multivariable analyses were performed to examine the association of bleeding and cramping patterns with short-term satisfaction. RESULTS: Our analytic sample included 5011 Contraceptive CHOICE Project participants: 3001 LNG-IUS users, 826 copper IUD users, and 1184 implant users. At 3 months, >65% of LNG-IUS and implant users reported no change or decreased cramping, while 63% of copper IUD users reported increased menstrual cramping. Lighter bleeding was reported by 67% of LNG-IUS users, 58% of implant users, and 8% of copper IUD users. Satisfaction of all LARC methods was high (≥90%). LARC users with increased menstrual cramping (relative risk adjusted [RRadj], 0.78; 95% confidence interval [CI], 0.72-0.85), heavier bleeding (RRadj, 0.83; 95% CI, 0.76-0.92), and increased bleeding frequency (RRadj, 0.73; 95% CI, 0.67-0.80) were less likely to report being very satisfied at 6 months. CONCLUSION: Regardless of the LARC method, satisfaction at 3 and 6 months is very high. Changes in self-reported bleeding and cramping are associated with short-term LARC satisfaction.

The role of contraceptive attributes in women's contraceptive decision making.

OBJECTIVE: Contraceptive methods have differing attributes. Women's preferences for these attributes may influence contraceptive decision making. Our objective was to identify women's contraceptive preferences among women initiating a new contraceptive method. STUDY DESIGN: We conducted a cross-sectional, self-administered survey of women's contraceptive preferences at the time of enrollment into the Contraceptive CHOICE Project. Participants were asked to rank the importance of 15 contraceptive attributes on a 3-point scale (1 = not at all important, 2 = somewhat important, and 3 = very important) and then to rank the 3 attributes that were the most important when choosing a contraceptive method. The survey also contained questions about prior contraceptive experience and barriers to contraceptive use. Information about demographic and reproductive characteristics was collected through the CHOICE Project baseline survey. RESULTS: There were 2590 women who completed the survey. Our sample was racially and socioeconomically diverse. Method attributes with the highest importance score (mean score [SD]) were effectiveness (2.97 [0.18]), safety (2.96 [0.22]), affordability (2.61 [0.61]), whether the method is long lasting (2.58 [0.61]), and whether the method is "forgettable" (2.54 [0.66]). The attributes most likely to be ranked by respondents among the top 3 attributes included effectiveness (84.2%), safety (67.8%), and side effects of the method (44.6%). CONCLUSION: Multiple contraceptive attributes influence decision making and no single attribute drives most women's decisions. Tailoring communication and helping women make complex tradeoffs between attributes can better support their contraceptive decisions and may assist them in making value-consistent choices. This process could improve continuation and satisfaction.

Medical contraindications in women seeking combined hormonal contraception.

OBJECTIVE: The objective of the study was to evaluate the prevalence of medical contraindications in a large group of women seeking combined hormonal contraception (CHC). STUDY DESIGN: The Contraceptive CHOICE Project is a prospective cohort study designed to promote the use of long-acting reversible contraceptive methods to reduce unintended pregnancies in the St Louis region. During baseline enrollment, participants were asked about their desired methods of contraception and medical history. Potential medical contraindications were defined as self-reported history of hypertension, myocardial infarction, cerebral vascular accidents, migraines with aura, any migraine and age 35 years or older, smoking in women older than 35 years, venous thromboembolism, or liver disease. We reviewed all research charts of women with self-reported medical contraindications to verify all conditions. Binomial 95% confidence intervals (CIs) were calculated around percentages. RESULTS: Between August 2007 and December 2009, 5087 women who enrolled in the CHOICE Project provided information about their medical history and 1010 women (19.9%) desired CHC at baseline. Seventy women (6.93%; 95% CI, 5.44-8.68%) were defined as having a potential medical contraindication to CHC at baseline. After chart review, only 24 of 1010 participants desiring CHC (2.38%; 95% CI, 1.53-3.52%) were found to have true medical contraindications to CHC including 17 with hypertension, 2 with migraines with aura, 2 with a history of venous thromboembolism, and 3 smokers aged 35 years or older. CONCLUSION: The prevalence of medical contraindications to CHC was very low in this large sample of reproductive-aged women. This low prevalence supports provision of CHC without a prescription.

The contraceptive CHOICE project round up: what we did and what we learned.

The Contraceptive CHOICE Project was a prospective cohort study of 9256 women in the St Louis area. The project provided no-cost reversible contraception to participants for 2 to 3 years with the goal of increasing uptake of long-acting reversible contraception and decreasing unintended pregnancy in the area. This manuscript will provide a brief summation of the major findings to date including the dramatic effect the project had on unintended pregnancy and abortion rates.

Sexually transmitted infection prevalence in a population seeking no-cost contraception.

BACKGROUND: We used universal screening to determine the prevalence rates of Neisseria gonorrhoeae (GC), Chlamydia trachomatis (CT), and Trichomonas vaginalis (TV) in 9256 women enrolling into a contraceptive study. METHODS: We offered screening using nucleic acid amplification or culture to all participants enrolling into the Contraceptive CHOICE Project. Demographic characteristics were collected through staff-administered questionnaires. Univariate and multivariable analyses were performed to assess the risk of sexually transmitted infection at baseline and to compare risk profiles of CT and TV. RESULTS: Results were available for 8347 consenting women with satisfactory results; 656 (7.9%) were tested positive for 1 or more infections. Approximately one third of participants were older than 26 years, and half were identified as African American. There were 35 cases of GC for a prevalence of 0.4% (95% confidence interval [CI], 0.3-0.6), 260 cases of CT for a prevalence of 3.1% (95% CI, 2.8-3.5), and 410 cases of TV for a prevalence of 4.9% (95% CI, 4.4-5.4). Black women were more likely to be tested positive (odds ratio, 3.95; 95% CI, 3.08-5.06) compared with white women and accounted for 81.3% of cases. T. vaginalis was more prevalent in black women (8.9%) compared with white women (0.9%). Older age was a risk factor for TV, whereas younger age was associated with CT. Of the 656 positive cases, 106 (16%) were diagnosed in women older than 25 years, falling outside traditional screening guidelines. CONCLUSION: We found GC, CT, and TV to be more prevalent than current national statistics, with TV being the most prevalent. Current screening recommendations would have missed 16% of infected women.

Validity of perceived weight gain in women using long-acting reversible contraception and depot medroxyprogesterone acetate.

OBJECTIVE: The objective of the study was to evaluate perceived weight gain in women using contraception and determine the validity of self-reported weight gain. STUDY DESIGN: We analyzed data from new contraceptive method users who self-reported a weight change at 3, 6, and 12 months after enrollment. We examined a subgroup of participants with objective weight measurements at baseline and 12 months to test the validity of self-reported weight gain. RESULTS: Thirty-four percent of participants (1407 of 4133) perceived weight gain. Compared with copper intrauterine device users, implant users (relative risk, 1.29; 95% confidence interval, 1.10-1.51) and depot medroxyprogesterone acetate users (relative risk, 1.37; 95% confidence interval, 1.14-1.64) were more likely to report perceived weight gain. Women who perceived weight gain experienced a mean weight gain of 10.3 pounds. The sensitivity and specificity of perceived weight gain were 74.6% and 84.4%, respectively. CONCLUSION: In most women, perceived weight gain represents true weight gain. Implant and depot medroxyprogesterone acetate users are more likely to perceive weight gain among contraception users.

The impact of emotional, physical, and sexual abuse on contraceptive method selection and discontinuation.

OBJECTIVES: We evaluated the impact of exposure to emotional, physical, or sexual abuse on contraceptive method selection and discontinuation. METHODS: We performed a secondary analysis of 7170 women enrolled in the Contraceptive CHOICE Project in St. Louis, Missouri, a prospective cohort study in which 9256 women were provided their preferred method of contraception at no cost from 2007 to 2011. We defined contraceptive discontinuation as device removal or nonuse for at least 4 weeks within the first 12 months after initiation. RESULTS: One third of women experienced some abuse in their lifetimes. Women with an abuse history were as likely as those without to select a long-acting reversible contraceptive method and more likely to choose a contraceptive injection, the patch, or the ring. When we compared women who were abused to those who were not, rates of discontinuation at 12 months were higher among women who selected long-acting reversible contraception (17% vs 14%; P = .04) and significantly higher among women who selected non-long-acting methods (56% vs 47%; P < .001). Type of abuse did not alter the association between abuse and contraceptive continuation. CONCLUSIONS: Previous experiences of abuse are associated with both contraceptive method selection and continuation.

Risk of bacterial vaginosis in users of the intrauterine device: a longitudinal study.

BACKGROUND: Users of the intrauterine device (IUD) may be at increased risk for bacterial vaginosis (BV). Our objective was to compare the incidence of BV in women using the IUD with women using combined oral contraceptives (COC), the contraceptive vaginal ring, and the contraceptive patch. METHODS: We prospectively recruited women negative for BV at baseline. Monthly, for 6 months, participants returned a self-obtained vaginal smear for Gram stain by mail. BV was diagnosed by a Nugent score ≥7. We performed Cox proportional hazards regression to investigate associations between demographic and behavioral characteristics, contraceptive method, and incident BV. RESULTS: We enrolled 153 women negative for BV at baseline; 90 (59%) women who chose the IUD and 63 (41%) who chose COC, ring, or patch. There were 35 women with BV at one or more time points. The incidence of BV was 37.0% among IUD users and 19.3% in COC, ring, and patch users (P = 0.03). In the univariate analysis, race, IUD use, intermediate flora, and irregular vaginal bleeding were significantly associated with BV. In the adjusted model, IUD users were no more likely to acquire BV (hazards ratio [HRadj]: 1.28, 95% confidence interval [CI]: 0.53-3.06) than COC, ring, and patch users. The associations between intermediate flora and irregular bleeding and BV remained significant (HRadj: 3.30, 95% CI: 1.51-7.21, and HRadj: 2.54, 95% CI: 1.03-6.24, respectively). CONCLUSIONS: The association between IUD use and BV appears to be mediated by irregular vaginal bleeding. Intermediate flora is associated with an increased incidence of BV.

A randomized trial of home versus clinic-based sexually transmitted disease screening among men.

BACKGROUND: Preventing sexually transmitted diseases (STD) such as Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) remains a public health challenge. The U.S. Preventive Services Task Force suggests STD screening among men will likely lead to a decrease in infection rates of women. However, innovative approaches are necessary to increase the traditionally low rates of male screening. The purpose of this study is to compare the acceptability and effectiveness of home-based versus clinic-based urine screening for CT and GC in men. METHODS: We conducted a randomized clinical trial of 200 men aged 18 to 45 years who reside in St. Louis, MO. Men were enrolled via telephone and randomly assigned to receive a free urine CT/GC screening kit either in-person at the research clinic or to have it mailed to the participant's preferred address. Participants completed questionnaires at baseline and 10 to 12 weeks postenrollment. The primary outcome was whether STD screening was completed. RESULTS: Sixty percent (120/200) completed STD screening. Men assigned to home-based screening were 60% more likely to complete screening compared with clinic-based screening (72% vs. 48%, RRadj = 1.6, 95% CI = 1.3, 2.00). We identified 4 cases of CT or GC in the home-based group compared with 3 cases of CT in the clinic group. Men who completed screening were significantly more likely to be white, younger, and college educated. CONCLUSIONS: Home-based screening for CT and GC among men is more acceptable than clinic-based screening and resulted in higher rates of screening completion. Incorporating home-based methods as adjuncts to traditional STD screening options shows promise in improving STD screening rates in men.

Predictors of male partner treatment for sexually transmitted infection.

BACKGROUND: Patient-initiated notification is a commonly used practice for notifying sex partners of possible exposure to a sexually transmitted infection (STI); however, 46% to 75% of partners are never treated. The Contraceptive CHOICE Project (CHOICE) is a longitudinal cohort study of women that provides no-cost contraception, STI testing, treatment to participants, and free partner treatment. Our objective was to evaluate characteristics of women who tested positive for chlamydia, gonorrhea, or trichomoniasis, and their association with successful partner treatment. METHODS: We analyzed baseline survey and STI testing, notification, and treatment data from the first 5087 participants enrolled in CHOICE. We considered "treated partners" to be men who received antibiotic treatment at the study clinic or by a prescription through the study. Independent predictors of successful partner treatment were identified using univariate analysis and multivariable analysis using Poisson regression with robust error variance. RESULTS: Forty-four percent of male partners were successfully treated. Women whose partners were less likely to obtain treatment were black (adjusted Relative Risk (RR adj) RR adj = 0.6; 95% confidence interval [CI]: 0.5-0.8) or reported some concern about future STI with the partner (RR adj = 0.6; 95% CI: 0.4, 0.8). Women whose partners were more likely to receive treatment were living with their partner (RR adj = 1.4; 95% CI: 1.1-1.8) or reported recent inconsistent condom use (RR adj = 1.5; 95% CI: 1.1-2.1). CONCLUSIONS: The male partner treatment rate resulting from female patient-initiated partner notification in our study was low. Our findings highlight the need to develop novel notification interventions that yield higher partner treatment rates and consider patient-specific factors, such as race and relationship status.

Factors associated with screening for sexually transmitted infections.

OBJECTIVE: The purpose of this study was to determine predictors of the completion of free annual sexually transmitted infection screening among sexually active young women of ≤ 25 years old. STUDY DESIGN: We analyzed survey data from 2607 sexually active women who were enrolled in the Contraceptive CHOICE Project, a prospective cohort study. We evaluated demographic characteristics, sexual risk behaviors, relationship characteristics, and contraceptive methods. Receipt of a home- or clinic-based test kit within 56 days of the 12-month survey constituted a completed screen. A multivariable model to predict screening completion was created with the use of Poisson regression with robust error variance. RESULTS: Fifty-seven percent of the women completed the screening. Screening completion was associated most strongly with a college education or higher (adjusted relative risk, 1.2; 95% confidence interval, 1.1-1.3) and home-based testing (adjusted relative risk, 1.3; 95% confidence interval, 1.2-1.5). CONCLUSION: Free and home-based testing increased screening rates among young women. To meet annual testing guidelines, the availability and use of home-based testing kits should increase.

Cervical lidocaine for IUD insertional pain: a randomized controlled trial.

OBJECTIVE: Anticipated pain with intrauterine device (IUD) insertion may be a barrier to widespread use. Our objective was to evaluate the efficacy of intracervical 2% lidocaine gel for pain relief with IUD insertion. STUDY DESIGN: We performed a double-blind, randomized controlled trial of women undergoing IUD insertion. Participants were randomly assigned to 2% lidocaine or placebo gel. Study gel (3 mL) was placed 3 minutes prior to IUD insertion. Pain scores were measured at various time points using a 10-point visual analog scale. RESULTS: Of the 200 participants randomized, 199 completed the study. Pain scores among lidocaine and placebo arms were similar at tenaculum placement (lidocaine and placebo: median, 4; range, 0-10; P = .15) and with insertion (lidocaine: median, 5; range, 1-10; placebo: median, 6; range, 0-10; P = .16). These results did not differ by parity. CONCLUSION: Topical or intracervical 2% lidocaine gel prior to IUD insertion does not decrease pain scores.

Naproxen or estradiol for bleeding and spotting with the levonorgestrel intrauterine system: a randomized controlled trial.

OBJECTIVE: The purpose of this study was to evaluate whether oral naproxen or transdermal estradiol decreases bleeding and spotting in women who are initiating the levonorgestrel-releasing intrauterine system. STUDY DESIGN: We conducted a randomized controlled trial of naproxen, estradiol, or placebo that was administered over the first 12 weeks of levonorgestrel-releasing intrauterine system use. Participants completed a written bleeding diary. We imputed missing values and performed an intention-to-treat analysis. RESULTS: There were 129 women who were assigned randomly to naproxen (n = 42 women), estradiol (n = 44 women), or placebo (n = 43 women). The naproxen group was more likely to be in the lowest quartile of bleeding and spotting days compared with placebo (42.9% vs 16.3%; P = .03). In the multivariable analysis, the naproxen group had a 10% reduction in bleeding and spotting days (adjusted relative risk, 0.90; 95% confidence interval, 0.84-0.97) compared with placebo. More frequent bleeding and spotting was observed in the estradiol group (adjusted relative risk, 1.25; 95% confidence interval, 1.17-1.34). CONCLUSION: The administration of naproxen resulted in a reduction in bleeding and spotting days compared with placebo.

Knowledge of contraceptive effectiveness.

OBJECTIVE: The purpose of this study was to determine women's knowledge of contraceptive effectiveness. STUDY DESIGN: We performed a cross-sectional analysis of a contraceptive knowledge questionnaire that had been completed by 4144 women who were enrolled in the Contraceptive CHOICE Project before they received comprehensive contraceptive counseling and chose their method. For each contraceptive method, women were asked "what percentage would get pregnant in a year: <1%, 1-5%, 6-10%, >10%, don't know." RESULTS: Overall, 86% of subjects knew that the annual risk of pregnancy is >10% if no contraception is used. More than 45% of women overestimate the effectiveness of depo-medroxyprogesterone acetate, pills, the patch, the ring, and condoms. After adjustment for age, education, and contraceptive history, the data showed that women who chose the intrauterine device (adjusted relative risk, 6.9; 95% confidence interval, 5.6-8.5) or implant (adjusted relative risk, 5.9; 95% confidence interval, 4.7-7.3) were significantly more likely to identify the effectiveness of their method accurately compared with women who chose either the pill, patch, or ring. CONCLUSION: This cohort demonstrated significant knowledge gaps regarding contraceptive effectiveness and over-estimated the effectiveness of pills, the patch, the ring, depo-medroxyprogesterone acetate, and condoms.