Colleen McNicholas

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.).

Efficacy and Safety of Long-Acting Reversible Contraception

Long-acting reversible contraception (LARC) includes intrauterine devices (IUDs) and the subdermal implant. These methods are the most effective reversible methods of contraception, and have the additional advantages of being long-lasting, convenient, well liked by users and cost effective. Compared with other user-dependent methods that increase the risk of noncompliance-related method failure, LARC methods can bring ‘typical use’ failure rates more in line with ‘perfect use’ failure rates. LARC methods are ‘forgettable’; they are not dependent on compliance with a pill-taking regimen, remembering to change a patch or ring, or coming back to the clinician for an injection. LARC method failure rates rival that of tubal sterilization at <1% for IUDs and the subdermal implant. For these reasons, we believe that IUDs and implants should be offered as first-line contraception for most women. This article provides a review of the LARC methods that are currently available in the US, including their effectiveness, advantages, disadvantages and contraindications. Additionally, we dispel myths and misconceptions regarding IUDs, and address the barriers to LARC use.

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

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.

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

Long-acting reversible contraception for adolescents.

Purpose of review Teen pregnancy continues to plague the United States. This review will discuss long-acting reversible contraceptive (LARC) method use in teens, comprising intrauterine devices and subdermal implants. Recent findings The American College of Obstetricians and Gynecologists along with the American Academy of Pediatrics, the Centers for Disease Control, and the World Health Organization have recognized the potential impact of LARC (comprising intrauterine contraception and subdermal implants) to reduce unintended pregnancies. They have affirmed the safety of such devices, and no effects on long-term fertility have been identified. Teen users of these methods have been shown to have high continuation and satisfaction rates. On the contrary, oral contraceptive pills, the patch, and the contraceptive vaginal ring have significantly higher contraceptive failure rates, and these rates are magnified in young women. Summary LARC methods should be considered first-line options for teens seeking contraception.

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.

Immediate postabortion intrauterine device insertion: continuation and satisfaction.

BACKGROUND The provision of intrauterine devices (IUDs) immediately postabortion has the potential to decrease unintended pregnancy in the United States. Studies have demonstrated safety and efficacy; however, there are limited data about continuation, satisfaction, and bleeding patterns among women receiving immediate postabortion IUDs. STUDY DESIGN We performed a retrospective cohort study of women undergoing immediate postabortion IUD insertion. Demographics and clinical data were collected from intake forms and procedure notes. We attempted to contact women by telephone to administer a short questionnaire to assess continuation, satisfaction, and bleeding patterns. RESULTS We were able to contact 77 of 225 (34%). Women lost to follow-up were more likely to have higher parity or a pregnancy of greater gestational age at the time of abortion compared with women who were successfully contacted. Continuation and satisfaction rates were high (80.5% and 80.6%, respectively). Reported bleeding patterns with IUD use were similar to previously reported patterns. CONCLUSION Follow-up of women undergoing immediate postabortion IUD insertion is challenging. However, we found that women choosing immediate postabortion IUD had high rates of continuation and satisfaction.

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.

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.