Comparison of No-Test Telehealth and In-Person Medication Abortion.

Importance: In the US, access to medication abortion using history-based (no-test) eligibility assessment, including through telehealth and mailing of mifepristone, has grown rapidly. Additional evidence on the effectiveness and safety of these models is needed. Objective: To evaluate whether medication abortion with no-test eligibility assessment and mailing of medications is as effective as in-person care with ultrasonography and safe overall. Design, Setting, and Participants: Prospective, observational study with noninferiority analysis. Sites included 4 abortion-providing organizations in Colorado, Illinois, Maryland, Minnesota, Virginia, and Washington from May 2021 to March 2023. Eligible patients were seeking medication abortion up to and including 70 days' gestation, spoke English or Spanish, and were aged 15 years or older. Exposure: Study groups reflected the model of care selected by the patient and clinicians and included: (1) no-test (telehealth) eligibility assessment and mailing of medications (no-test + mail) (n = 228); (2) no-test eligibility assessment and pickup of medications (no-test + pickup) (n = 119); or (3) in-person with ultrasonography (n = 238). Main Outcomes and Measures: Effectiveness, defined as a complete abortion without the need for repeating the mifepristone and misoprostol regimen or a follow-up procedure, and safety, defined as an abortion-related serious adverse event, including overnight hospital admission, surgery, or blood transfusion. Outcomes were derived from patient surveys and medical records. Primary analysis focused on the comparison of the no-test + mail group with the in-person with ultrasonography group. Results: The mean age of the participants (N = 585) was 27.3 years; most identified as non-Hispanic White (48.6%) or non-Hispanic Black (28.1%). Median (IQR) gestational duration was 45 days (39-53) and comparable between study groups (P = .30). Outcome data were available for 91.8% of participants. Overall effectiveness was 94.4% (95% CI, 90.7%-99.2%) in the no-test + mail group and 93.3% (95% CI, 88.3%-98.2%) in the in-person with ultrasonography group in adjusted models (adjusted risk difference, 1.2 [95% CI, -4.1 to 6.4]), meeting the prespecified 5% noninferiority margin. Serious adverse events included overnight hospitalization (n = 4), blood transfusion (n = 2), and emergency surgery (n = 1) and were reported by 1.1% (95% CI, 0.4%-2.4%) of participants, with 3 in the no-test + mail group, 3 in the in-person with ultrasonography group, and none in the no-test + pickup group. Conclusions and Relevance: This prospective, observational study found that medication abortion obtained following no-test telehealth screening and mailing of medications was associated with similar rates of complete abortion compared with in-person care with ultrasonography and met prespecified criteria for noninferiority, with a low prevalence of adverse events.

Are sexual and reproductive health and rights taught in medical school? Results from a global survey.

Our aim was to investigate the inclusion of sexual and reproductive health and rights (SRHR) topics in medical curricula and the perceived need for, feasibility of, and barriers to teaching SRHR. We distributed a survey with questions on SRHR content, and factors regulating SRHR content, to medical universities worldwide using chain referral. Associations between high SRHR content and independent variables were analyzed using unconditional linear regression or χ2 test. Text data were analyzed by thematic analysis. We collected data from 219 respondents, 143 universities and 54 countries. Clinical SRHR topics such as safe pregnancy and childbirth (95.7%) and contraceptive methods (97.2%) were more frequently reported as taught compared with complex SRHR topics such as sexual violence (63.8%), unsafe abortion (65.7%), and the vulnerability of LGBTQIA persons (23.2%). High SRHR content was associated with high-income level (P = 0.003) and low abortion restriction (P = 0.042) but varied within settings. Most respondents described teaching SRHR as essential to the health of society. Complexity was cited as a barrier, as were cultural taboos, lack of stakeholder recognition, and dependency on fees and ranking.

Comparison of procedure time between manual and electric vacuum aspiration for pregnancy termination between 10-14 weeks: A randomized trial.

OBJECTIVE: To measure the difference in procedure time between manual vacuum aspiration (MVA) and electric vacuum aspiration (EVA) during abortion procedures between 10 0/7 and 13 6/7 weeks gestation. STUDY DESIGN: We conducted a 1:1 randomized trial of individuals undergoing an abortion procedure between 10 0/7 and 13 6/7 weeks to MVA or EVA. Procedure time was the primary outcome. We performed an intention-to-treat analysis. A total of 132 patients (66 per arm) were needed to identify a 2-minute difference in time with 90% power and an alpha of 0.05. Given the non-parametric distribution of procedure times, we used Mann-Whitney U test to assess for differences in median procedure times. RESULTS: We randomized 146 participants; 74 to MVA and 72 to EVA. Median procedure times were similar between the 2 groups; EVA 2.4 minutes (range 0.9-6.9 min) and MVA 2.6 minutes (range 1.1-9.0 min, p = 0.12). When stratified by gestational age, EVA between 12 0/7 and 13 6/7 weeks had a shorter median procedure time compared to MVA (2.5 min, range 1.4-6.9 min vs. 3.5 min range 1.7-9.0), respectively (p = 0.005). One conversion occurred from MVA to EVA at 13 weeks. CONCLUSION: We found no difference in procedure time between MVA and EVA between 10 0/7 and 13 6/7 weeks gestation. MVA does take 1 minute longer than EVA when performed between 12 0/7-13 6/7 weeks; however, this difference is not likely be clinically significant. IMPLICATIONS: Procedure times are similar for manual and electric vacuum aspiration for uterine evacuation between 10 and 14 weeks and the rate of conversion is low.

Differences in Financial and Social Burdens Experienced by Patients Traveling for Abortion Care.

OBJECTIVE: We compared perceived stress between women traveling 50 or fewer miles and more than 50 miles for abortion care. Secondary objectives were to compare individual-level stigma and hardship scores in patients by distance traveled to the clinic. METHODS: We performed a cross-sectional study of patients presenting for care at an independent abortion clinic in southern Illinois. Participants completed a self-administered, tablet computer-based survey asking about their experiences seeking abortion, including the Perceived Stress Scale (PSS) and Individual Level Abortion Stigma (ILAS) scale. We created a composite score to characterize patient hardship regarding abortion care (range, 0-4). We examined responses stratified by the patients' self-reported one-way distance traveled to the clinic (group 1, ≤50 miles; group 2, >50 miles). RESULTS: A total of 308 women completed the survey. There was no significant difference in mean PSS scores (p = .71) or median ILAS scores (p = .40) between groups. A majority of the cohort reported moderate or high stress (68.2%). The median hardship score was significantly higher in the greater than 50 mile group (median, 1 [interquartile range, 0-2] vs. 2 [interquartile range 1-3]; p < .001). Patients who traveled more than 50 miles reported difficulties related to missing work (58.3%), delays in obtaining an abortion owing to financial costs (35.7%), lodging (13.9%), and transportation (11.3%). CONCLUSIONS: There was no difference in PSS or ILAS scores by distance traveled among patients seeking an abortion; however, patients who traveled more than 50 miles had a higher hardship score, suggesting greater difficulty accessing abortion. The most common difficulties encountered included missing time from work and financial costs associated with the abortion.

How the coronavirus disease 2019 pandemic is impacting sexual and reproductive health and rights and response: Results from a global survey of providers, researchers, and policy-makers.

INTRODUCTION: We aimed to give a global overview of trends in access to sexual and reproductive health and rights (SRHR) during the coronavirus disease 2019 (COVID-19) pandemic and what is being done to mitigate its impact. MATERIAL AND METHODS: We performed a descriptive analysis and content analysis based on an online survey among clinicians, researchers, and organizations. Our data were extracted from multiple-choice questions on access to SRHR services and risk of SRHR violations, and written responses to open-ended questions on threats to access and required response. RESULTS: The survey was answered by 51 people representing 29 countries. Eighty-six percent reported that access to contraceptive services was less or much less because of COVID-19, corresponding figures for surgical and medical abortion were 62% and 46%. The increased risk of gender-based and sexual violence was assessed as moderate or severe by 79%. Among countries with mildly restrictive abortion policies, 69% had implemented changes to facilitate access to abortion during the pandemic, compared with none among countries with severe restrictions (P < .001), 87.5% compared with 46% had implemented changes to facilitate access to contraception (P = .023). The content analysis showed that (a) prioritizations in health service delivery at the expense of SRHR, (b) lack of political will, (c) the detrimental effect of lockdown, and (d) the suspension of sexual education, were threats to SRHR access (theme 1). Requirements to mitigate these threats (theme 2) were (a) political will and support of universal access to SRH services, (b) the sensitization of providers, (c) free public transport, and (d) physical protective equipment. A contrasting third theme was the state of exception of the COVID-19 pandemic as a window of opportunity to push forward women's health and rights. CONCLUSIONS: Many countries have seen decreased access to and increased violations of SRHR during the COVID-19 pandemic. Countries with severe restrictions on abortion seem less likely to have implemented changes to SRHR delivery to mitigate this impact. Political will to support the advancement of SRHR is often lacking, which is fundamental to ensuring both continued access and, in a minority of cases, the solidification of gains made to SRHR during the pandemic.

Ulipristal Acetate for Unscheduled Bleeding in Etonogestrel Implant Users: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether ulipristal acetate reduces the number of bleeding days in etonogestrel implant users in a 30-day period as compared with placebo. METHODS: We performed a single-center, randomized, double-blind, placebo-controlled trial. Eligible participants were women aged 18-45 years with an etonogestrel implant in place for greater than 90 days and less than 3 years who reported greater than one bleeding episode in a 24-day period. Enrolled participants were randomized to receive 15 mg ulipristal acetate compared with an identical-appearing placebo daily for 7 days. Participants completed daily bleeding diaries using automated text messaging to evaluate whether ulipristal acetate reduces the number of bleeding days as compared with placebo. Secondary outcomes included participant satisfaction with bleeding and the effect of ulipristal acetate on ovulation status. A sample size of 52 per group (n=104) was planned, calculated with an effect size of a 30% reduction in bleeding days, SD of 10 days, and dropout of 15%. Our study was terminated early (N=65) as a result of a U.S. Food and Drug Administration hold, but power was sufficient for analysis. The effect of ulipristal acetate on ovulatory potential was evaluated in a subset with weekly serum progesterone. RESULTS: From May 2017 to January 2018, 65 women were allocated to receive 15 mg ulipristal acetate (n=32) or placebo (n=33) daily for 7 days. Demographic characteristics were similar between groups. Women randomized to ulipristal acetate reported 5 fewer days of bleeding over a 30-day reference period after treatment (P=.002). At the conclusion of the 30-day follow-up period, women in the ulipristal acetate group were more satisfied with their bleeding profile than the placebo group (87.5% vs 60%, respectively; P<.001). Serum progesterone levels were nonovulatory in a subset of each group (placebo group range: less than 0.2-1.3 ng/mL; ulipristal acetate group range: less than 0.2-4.4 ng/mL). CONCLUSION: Ulipristal acetate is well-tolerated and reduced the number of bleeding days in etonogestrel implant users in our study. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03118297.

Condom use and incident sexually transmitted infection after initiation of long-acting reversible contraception.

BACKGROUND: Use of more effective contraception may lead to less condom use and increased incidence of sexually transmitted infection. OBJECTIVE: The objective of this study was to compare changes in condom use and incidence of sexually transmitted infection acquisition among new initiators of long-acting reversible contraceptives to those initiating non-long-acting reversible contraceptive methods. STUDY DESIGN: This is a secondary analysis of the Contraceptive CHOICE Project. We included 2 sample populations of 12-month continuous contraceptive users. The first included users with complete condom data (baseline, and 3, 6, and 12 months) (long-acting reversible contraceptive users: N = 2371; other methods: N = 575). The second included users with 12-month sexually transmitted infection data (long-acting reversible contraceptive users: N = 2102; other methods: N = 592). Self-reported condom use was assessed at baseline and at 3, 6, and 12 months following enrollment. Changes in condom use and incident sexually transmitted infection rates were compared using χ2 tests. Risk factors for sexually transmitted infection acquisition were identified using multivariable logistic regression. RESULTS: Few participants in either group reported consistent condom use across all survey time points and with all partners (long-acting reversible contraceptive users: 5.2%; other methods: 11.3%; P < .001). There was no difference in change of condom use at 3, 6, and 12 months compared to baseline condom use regardless of method type (P = .65). A total of 94 incident sexually transmitted infections were documented, with long-acting reversible contraceptive users accounting for a higher proportion (3.9% vs 2.0%; P = .03). Initiation of a long-acting reversible contraceptive method was associated with increased sexually transmitted infection incidence (odds ratio, 2.0; 95% confidence ratio, 1.07-3.72). CONCLUSION: Long-acting reversible contraceptive initiators reported lower rates of consistent condom use, but did not demonstrate a change in condom use when compared to preinitiation behaviors. Long-acting reversible contraceptive users were more likely to acquire a sexually transmitted infection in the 12 months following initiation.

Socioeconomic Status As a Risk Factor for Unintended Pregnancy in the Contraceptive CHOICE Project.

OBJECTIVE: To evaluate the association of low socioeconomic status as an independent risk factor for unintended pregnancy. METHODS: We performed a secondary analysis of data from the Contraceptive CHOICE project. Between 2007 and 2011, 9,256 participants were recruited and followed for up to 3 years. The primary outcome of interest was unintended pregnancy; the primary exposure variable was low socioeconomic status, defined as self-report of either receiving public assistance or having difficulty paying for basic necessities. Four contraceptive groups were evaluated: 1) long-acting reversible contraceptive method (hormonal or copper intrauterine device or subdermal implant); 2) depot medroxyprogesterone acetate injection; 3) oral contraceptive pills, a transdermal patch, or a vaginal ring; or 4) other or no method. Confounders were adjusted for in the multivariable Cox proportional hazard model to estimate the effect of socioeconomic status on risk of unintended pregnancy. RESULTS: Participants with low socioeconomic status experienced 515 unintended pregnancies during 14,001 women-years of follow-up (3.68/100 women-years; 95% CI 3.37-4.01) compared with 200 unintended pregnancies during 10,296 women-years (1.94/100 women-years; 95% CI 1.68-2.23) among participants without low socioeconomic status. Women with low socioeconomic status were more likely to have an unintended pregnancy (unadjusted hazard ratio [HR] 1.8, 95% CI 1.5-2.2). After adjusting for age, education level, insurance status, and history of unintended pregnancy, low socioeconomic status was associated with an increased risk of unintended pregnancy (adjusted HR 1.4, 95% CI 1.1-1.7). CONCLUSION: Despite the removal of cost barriers, low socioeconomic status is associated with a higher incidence of unintended pregnancy.

Prolonged use of the etonogestrel implant and levonorgestrel intrauterine device: 2 years beyond Food and Drug Administration-approved duration.

BACKGROUND: The subdermal contraceptive implant and the 52-mg levonorgestrel intrauterine device are currently Food and Drug Administration approved for 3 and 5 years of use, respectively. Limited available data suggested both of these methods are effective beyond that time. Demonstration of prolonged effectiveness will improve the cost-effectiveness of the device, and potentially patient continuation and satisfaction. OBJECTIVE: We sought to evaluate the effectiveness of the contraceptive implant and the 52-mg hormonal intrauterine device in women using the method for 2 years beyond the current Food and Drug Administration-approved duration. STUDY DESIGN: We initiated this ongoing prospective cohort study in January 2012. We are enrolling women using the contraceptive implant or 52-mg levonorgestrel intrauterine device for a minimum of 3 and 5 years, respectively (started intrauterine device in ≥2007 or implant in ≥2009). Demographic and reproductive health histories, as well as objective body mass index, were collected. Implant users were offered periodic venipuncture for analysis of serum etonogestrel levels. The primary outcome, unintended pregnancy rate, was calculated per 100 woman-years. We analyzed baseline demographic characteristics using χ2 test and Fisher exact test, and compared serum etonogestrel levels stratified by body mass index using the Kruskal-Wallis test. RESULTS: Implant users (n = 291) have contributed 444.0 woman-years of follow-up. There have been no documented pregnancies in implant users during the 2 years of postexpiration follow-up. Calculated failure rates in the fourth and fifth years for the implant are calculated as 0 (1-sided 97.5% confidence interval, 0-1.48) per 100 woman-years at 4 years and 0 (1-sided 97.5% confidence interval, 0-2.65) per 100 woman-years at 5 years. Among 496 levonorgestrel intrauterine device users, 696.9 woman-years of follow-up have been completed. Two pregnancies have been reported. The failure rate in the sixth year of use of the levonorgestrel intrauterine device is calculated as 0.25 (95% confidence interval, 0.04-1.42) per 100 woman-years; failure rate during the seventh year is 0.43 (95% confidence interval, 0.08-2.39) per 100 woman-years. Among implant users with serum etonogestrel results, the median etonogestrel level was 207.7 pg/mL (range 63.8-802.6 pg/mL) at the time of method expiration, 166.1 pg/mL (range 67.9 25.0-470.5 pg/mL) at the end of the fourth year, and 153.0 pg/mL (range 72.1-538.8 pg/mL) at the end of the fifth year. Median etonogestrel levels were compared by body mass index at each time point and a statistical difference was noted at the end of 4 years of use with overweight women having the highest serum etonogestrel (195.9; range 25.0-450.5 pg/mL) when compared to normal (178.9; range 87.0-463.7 pg/mL) and obese (137.9; range 66.0-470.5 pg/mL) women (P = .04). CONCLUSION: This study indicates that the contraceptive implant and 52-mg hormonal intrauterine device continue to be highly effective for at least 2 additional years of use. Serum etonogestrel evaluation demonstrates median levels remain above the ovulation threshold of 90 pg/mL for women in all body mass index classes.

Unscheduled vaginal bleeding with progestin-only contraceptive use.

Nearly 20% of women using contraception are using progestin-only contraception, including progestin-only pills, depot-medroxyprogesterone acetate, subdermal etonogestrel implants, and levonorgestrel intrauterine devices. This number will continue to grow with the increased provision of long-acting reversible contraception. Although overall satisfaction among women using progestin-only contraception is high, dissatisfaction and discontinuation may be associated with unscheduled bleeding and spotting. The exact etiology of irregular bleeding associated with progestin-containing contraceptives is not completely understood, yet several mechanisms have been suggested. Several therapies targeting these mechanisms have been evaluated with mixed results. This paper will review the physiology and management of unscheduled bleeding with progestin-containing contraceptives.

Long-acting reversible contraception use among residents in obstetrics/gynecology training programs.

BACKGROUND: The objective of the study was to estimate the personal usage of long-acting reversible contraception (LARC) among obstetrics and gynecology (Ob/Gyn) residents in the United States and compare usage between programs with and without a Ryan Residency Training Program (Ryan Program), an educational program implemented to enhance resident training in family planning. MATERIALS AND METHODS: We performed a web-based, cross-sectional survey to explore contraceptive use among Ob/Gyn residents between November and December 2014. Thirty-two Ob/Gyn programs were invited to participate, and 24 programs (75%) agreed to participate. We divided respondents into two groups based on whether or not their program had a Ryan Program. We excluded male residents without a current female partner as well as residents who were currently pregnant or trying to conceive. We evaluated predictors of LARC use using bivariate analysis and multivariable Poisson regression. RESULTS: Of the 638 residents surveyed, 384 (60.2%) responded to our survey and 351 were eligible for analysis. Of those analyzed, 49.3% (95% confidence interval [CI]: 44.1%, 54.5%) reported current LARC use: 70.0% of residents in Ryan Programs compared to 26.8% in non-Ryan Programs (RRadj 2.14, 95% CI 1.63-2.80). Residents reporting a religious affiliation were less likely to use LARC than those who described themselves as non-religious (RRadj 0.76, 95% CI 0.64-0.92). Of residents reporting LARC use, 91% were using the levonorgestrel intrauterine device. CONCLUSION: LARC use in this population of women's health specialists is substantially higher than in the general population (49% vs. 12%). Ob/Gyn residents in programs affiliated with the Ryan Program were more likely to use LARC.

Meeting the Contraceptive Needs of a Community: Increasing Access to Long-Acting Reversible Contraception.

To control their reproductive lives, women must have access to all contraceptive methods including the most effective reversible methods, intrauterine devices, and implants. The Contraceptive CHOICE Project, a study of 9,256 women in St. Louis, showed that when barriers to contraception are removed, many women choose intrauterine devices and implants, substantially reducing rates of unintended pregnancy and abortion. This article discusses strategies we learned from the CHOICE Project to improve uptake of the most effective contraceptive methods.

Association of baseline bleeding pattern on amenorrhea with levonorgestrel intrauterine system use.

OBJECTIVE: This study aims to evaluate the effect of baseline bleeding patterns on rates of amenorrhea reported at 12 months in levonorgestrel (LNG) 52 mg intrauterine system (IUS) users. We also assessed the effect of baseline bleeding patterns at 3 and 6 months postinsertion. STUDY DESIGN: In this secondary analysis of the Contraceptive CHOICE Project, we included participants who had an LNG-IUS inserted within 1 month of enrollment and continued use for 12 months. Using 12-month telephone survey data, we defined amenorrhea at 12 months of use as no bleeding or spotting during the previous 6 months. We used chi-square and multivariable logistic regression to assess the association of baseline bleeding pattern with amenorrhea while controlling for confounding variables. RESULTS: Of 1802 continuous 12-month LNG-IUS users, amenorrhea was reported by 4.9%, 14.8% and 15.4% of participants at 3, 6 and 12 months, receptively. Participants with light baseline bleeding or short duration of flow reported higher rates of amenorrhea at 3 and 6 months postinsertion (p<.03), while LNG-IUS users with heavy or prolonged flow were less likely to report amenorrhea at 3 and 6 months (p<.03). In a multivariable analysis, participants with self-reported heavy bleeding at baseline were less likely to report amenorrhea at 12 months than those who reported moderate bleeding (ORadj, 0.36; 95% CI, 0.16-0.69). CONCLUSION: Women with heavier menstrual bleeding are less likely than women with moderate flow to report amenorrhea following 12 months of LNG-IUS use. IMPLICATIONS: Baseline heavy menstrual flow reduces the likelihood of amenorrhea with LNG-IUS use, information that could impact contraceptive counseling. Anticipatory counseling can improve method satisfaction and continuation, an important strategy to continue to reduce unintended pregnancy and abortion rates.

Combined oral contraceptive treatment for bleeding complaints with the etonogestrel contraceptive implant: a randomised controlled trial.

OBJECTIVE: Estimate symptom improvement rate of women with bleeding complaints using the etonogestrel contraceptive implant when started on continuous combined oral contraceptives (COC). METHODS: We conducted a double-blinded randomised controlled trial of women reporting troublesome bleeding related to their etonogestrel contraceptive implant and desiring intervention. Participants received continuous COCs or placebo for four weeks to evaluate self-reported bleeding improvement at four weeks. Participants could continue study treatment or prescribed COCs for another eight weeks if desired. We planned to enroll 130 participants between two sites (80% power to detect a 20% effect size at a 0.05 significance level, with 10% loss to follow up). RESULTS: We closed the study after enrolling 26 participants due to recruitment futility. All women on COCs and 75% of placebo users reported bleeding improvement at four weeks (p = 0.09), with 92% and 42%, respectively, reporting significant improvement (p = 0.03). The median number of days until bleeding stopped for at least four days in COC and placebo users was 1 day (range 1-9) and 4.5 days (range 1-28), respectively (p = 0.63). Eight (75%) COC and five (42%) placebo users opted to continue study treatment (p = 0.41). Despite bleeding improvement, women who desired implant removal at enrollment were more likely to re-request removal than those who initially considered other interventions (3 of 5 [60%] vs 1 of 17 [6%], p = 0.03). CONCLUSION: Although women who have troublesome bleeding while using the contraceptive implant may experience improvement with no treatment over 4 weeks, women using COCs are more likely to report significant improvement. Clinicaltrials.gov registration number: NCT01963403.

Risk-based screening for Chlamydia trachomatis and Neisseria gonorrhoeae prior to intrauterine device insertion.

OBJECTIVE: The objective was to compare three strategies for Chlamydia trachomatis and Neisseria gonorrhoeae screening prior to intrauterine device (IUD) insertion. STUDY DESIGN: This was a secondary analysis of the Contraceptive CHOICE Project. We measured the prevalence of C. trachomatis and/or N. gonorrhoeae at the time of IUD insertion. We then compared sensitivity, specificity, negative and positive predictive values, and likelihood ratios for three screening strategies for C. trachomatis and N. gonorrhoeae prior to IUD insertion: (a) "age-based" ­ age ≤25 years alone; (b) "age/partner-based" ­ age ≤25 and/or multiple sexual partners; and (c) "risk-based" ­ age ≤25, multiple sexual partners, inconsistent condom use and/or history of prior sexually transmitted infection (STI). RESULTS: Among 5087 IUD users, 140 (2.8%) tested positive for C. trachomatis, 16 (0.3%) tested positive for N. gonorrhoeae, and 6 (0.1%) were positive for both at the time of IUD insertion. The "risk-based" screening strategy had the highest sensitivity (99.3%) compared to "age-based" and "age/partner-based" screening (80.7% and 84.7%, respectively.) Only one (0.7%) woman with a chlamydia or gonorrhea infection would not have been screened using "risk-based" screening. CONCLUSION: A risk-based strategy to screen for C. trachomatis and N. gonorrhoeae prior to IUD insertion has higher sensitivity than screening based on age alone or age and multiple sexual partners. IMPLICATIONS: Using a risk-based screening strategy (age≤25, multiple sexual partners, inconsistent condom use and/or history of an STI) to determine who should be screened for C. trachomatis and N. gonorrhoeae prior to IUD insertion will miss very few cases of infection and obviates the need for universal screening.

Use of the etonogestrel implant and levonorgestrel intrauterine device beyond the U.S. Food and Drug Administration-approved duration.

OBJECTIVE: To evaluate the effectiveness of the contraceptive implant and the 52-mg hormonal intrauterine device (IUD) in women using the method beyond the current U.S. Food and Drug Administration (FDA)-approved duration of 3 and 5 years, respectively. METHODS: Women willing to continue using their implant or 52-mg levonorgestrel IUD beyond the FDA-approved duration were followed prospectively for contraceptive effectiveness. Unintended pregnancy rate per 100 women-years was calculated. Implant users are offered periodic venipuncture for analysis of serum etonogestrel levels. The Kruskal-Wallis test was used to compare the etonogestrel levels across body mass index (BMI) groups. RESULTS: Implant users (n=237) have contributed 229.4 women-years of follow-up, with 123 using the etonogestrel implant for 4 years and 34 using it for 5 years. Zero pregnancies have been documented, for a failure rate of 0 (one-sided 97.5% confidence interval [CI] 0-1.61) per 100 women-years. Among 263 levonorgestrel IUD users, 197.7 women-years of follow-up have been completed. One pregnancy was confirmed, for a failure rate of 0.51 (95% CI 0.01-2.82) per 100 women-years. Among implant users with serum etonogestrel results, the median and range of etonogestrel level at 3 years of use was 188.8 pg/mL (range 63.8-802.6 pg/mL) and 177.0 pg/mL (67.9-470.5 pg/mL) at 4 years of use. Etonogestrel levels did not differ by BMI at either time point (3 years: P=.79; 4 years: P=.47). CONCLUSION: Preliminary findings indicate the contraceptive implant and 52-mg hormonal IUD continue to be highly effective for an additional year beyond the FDA-approved 3 and 5 years. Serum etonogestrel levels indicate the implant contains adequate hormone for ovulation suppression at the end of both 3 and 4 years of use. LEVEL OF EVIDENCE: II.

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.

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.).

Association of age and parity with intrauterine device expulsion.

OBJECTIVE: To investigate whether age 14 to 19 years and nulliparity are associated with expulsion of levonorgestrel and copper intrauterine devices (IUDs). METHODS: This was a planned secondary analysis of the Contraceptive CHOICE Project. We used Kaplan-Meier survival analysis to estimate expulsion rates for the first levonorgestrel or copper IUD received during study participation. Cox proportional hazards regression models were used to investigate baseline characteristics associated with expulsion. RESULTS: A total of 5,403 females were included; 4,219 (78%) used the levonorgestrel IUD and 1,184 (22%) used the copper IUD. There were 432 initial expulsions reported. The 36-month cumulative expulsion rate was 10.2 per 100 IUD users and did not vary by IUD type (levonorgestrel IUD 10.1 compared with copper IUD 10.7, P=.99). In the bivariate analysis, multiple characteristics including age, nulliparity, immediate postabortion insertion, and heavy menses were associated with expulsion. The cumulative rate of expulsion was lower in nulliparous women compared with parous women (8.4 compared with 11.4; P<.001) and higher in females aged 14 to 19 compared with older women (18.8 compared with 9.3; P<.001). After adjusting for confounders and stratifying by IUD type, the hazard ratio of expulsion for females aged 14 to 19 years was 2.26 (95% confidence interval [CI] 1.68-3.06) for the levonorgestrel IUD and 3.06 (95% CI 1.75-5.33) for the copper IUD. Compared to parous levonorgestrel IUD users, expulsion was lower for nulliparous levonorgestrel IUD users (adjusted hazard ratio 0.59, 95% CI 0.44-0.78). CONCLUSION: IUD expulsions were not increased in nulliparous females. More expulsions were observed in females aged 14 to 19 compared with older women regardless of parity or IUD type. LEVEL OF EVIDENCE: : II.