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Divisions of Family Planning and Clinical Research, Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, MO
Divisions of Family Planning and Clinical Research, Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, MO
Divisions of Family Planning and Clinical Research, Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, MO
Divisions of Family Planning and Clinical Research, Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, MO
Divisions of Family Planning and Clinical Research, Department of Obstetrics and Gynecology, Washington University School of Medicine in St. Louis, St. Louis, MO
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.
Their use has increased in the United States over the past 2 decades; approximately 8.5% of women who use contraception report current use of a LARC method.
Daniels K, Daugherty J, Jones J. Current contraceptive status among women aged 15 -44: United States, 2011 -2013. NCHS data brief, no 173. Hyattsville, MD: National Center for Health Statistics. 2014.
However, data are lacking regarding continuation of LARC methods at 3 years in the United States. Some of the previous studies that assessed longer-term continuation randomly assigned women to a contraceptive method and included women from many different countries.
This multinational study randomly assigned women to the levonogestrel-20 (the predecessor to the current levonorgestrel-containing intrauterine device [LNG-IUD]) and the TCu380Ag (the predecessor to the current copper-intrauterine device [Cu-IUD]). Cumulative continuation at 3 years was 49% among LNG-20 users and 59% among TCu380Ag users. Other prospective studies found 3-year continuation rates of 67–78% among users of Cu-IUDs.
UNDP/UNFPA/WHO/World Bank IRG A randomized multicentre trial of the Multiload 375 and TCu380A IUDs in parous women: three-year results. UNDP/UNFPA/WHO/World Bank, Special Programme of Research, Development and Research Training in Human Reproduction: IUD Research Group.
A three-year comparative study of continuation rates, bleeding patterns and satisfaction in Australian women using a subdermal contraceptive implant or progestogen releasing-intrauterine system.
Eur J Contracept Reprod Health Care.2014; 19: 5-14
A three-year comparative study of continuation rates, bleeding patterns and satisfaction in Australian women using a subdermal contraceptive implant or progestogen releasing-intrauterine system.
Eur J Contracept Reprod Health Care.2014; 19: 5-14
This analysis was performed to estimate the rates of 36-month continuation of the baseline contraceptive method that was chosen and to compare continuation rates of LARC and non-LARC methods at enrollment into the Contraceptive CHOICE Project. In addition, we explored baseline characteristics that are associated with discontinuation of contraceptive methods. We hypothesized that 36-month continuation rates for the LARC methods would exceed 60% and that continuation would be significantly higher for LARC methods than non-LARC methods.
Materials and Methods
In 2007, the Contraceptive CHOICE Project (CHOICE) began recruiting women for a prospective observational cohort study. The goal of the study was to reduce the unintended pregnancy rate in the St. Louis, MO, area by promoting the most effective methods of contraception and eliminating the cost barrier to all forms of contraception. The methods have been reported in detail
but are described briefly below. The Human Research Protection Office at Washington University in St. Louis approved the study protocol before study recruitment.
Participants were referred to CHOICE through their health care providers, posted flyers, and word of mouth. Recruitment sites included local health care centers, 2 abortion care providers, and a university-associated clinical research center. Inclusion criteria included women who (1) were 14–45 years of age, (2) desired reversible contraception and were willing to start a new method, (3) were sexually active with a male partner or intended to be within 6 months, (4) who lived in or received reproductive care in the St. Louis area, and (5) were able to consent in English or Spanish. Women were excluded if they desired pregnancy in the next 12 months or were had had hysterectomy or permanent sterilization. Recruitment of the 9256 participants began in 2007 and was completed in 2011. All participants provided written informed consent before study enrollment.
All potential participants heard a standardized introduction to LARC methods; upon enrollment, they received additional contraceptive counseling.
LARC methods included the LNG-IUD, the Cu-IUD, and the 3-year subdermal implant. The contraceptive counseling reviewed all reversible methods in order of effectiveness from most to least effective. After a baseline interview, participants completed screening for sexually transmitted infections, received their contraceptive of choice at no cost, and were followed for 2 or 3 years, depending on the timing of enrollment. Follow-up telephone interviews were performed at 3 and 6 months then every 6 months thereafter for the duration of study participation. At the enrollment visit, each participant chose her baseline method. When possible, they would start that method immediately. In certain cases (such as when pregnancy could not be ruled out reasonably), the patient received a bridge method until they returned for the initiation of their chosen method. Bridge methods included depot medroxyprogesterone acetate (DMPA), oral contraceptive pills (OCPs), combined contraceptive patch, vaginal ring, or condoms. Participants were able to switch methods at any time during the follow-up period. For the purposes of this analysis, if a participant switched her method, we considered this a discontinuation of the baseline method. Women who received the implant were told that it was approved for up to 3 years of use. If a participant had the device removed and reinserted within the same month, it was not considered a discontinuation. Follow-up interviews focused on method use, complaints, complications, side-effects, method troubleshooting, reasons for method discontinuation, and pregnancies. CHOICE participants have unrestricted access to device removal, even after CHOICE ended.
This analysis included women who chose a LARC or a non-LARC method (DMPA, OCPs, contraceptive patch, or vaginal ring), started using their method by their 3-month survey, and completed their 36-month follow-up survey or had another data source that verified continuation or discontinuation at 3 years. Continuation rates at 3 years were estimated for each method. LARC methods were compared with non-LARC methods and were stratified by age (14–19 and 20–45 years old). Descriptive analyses were performed to describe demographic characteristics of participants with the use of chi-square test or t-test, where appropriate. Normality was assessed for continuous variables. The time-to-event for this survival analysis was calculated from method initiation to the time point when the participant discontinued her contraceptive method. If she was lost to follow up, she was censored at her last time of contact with CHOICE. Participants were censored if they discontinued a contraceptive method to attempt pregnancy. Kaplan-Meier survival functions were used to estimate continuation rates among different methods. We used Cox proportional hazard models to estimate hazard ratios for risk of contraceptive method discontinuation for characteristics that were associated with discontinuation. We defined confounders as variables that changed the estimate of hazard ratio for a contraceptive method by ≥10% when they were included in the model. Confounding variables and significant factors from univariable analysis or variables that were set a priori were included in the final multivariable model to evaluate their effect size. The alpha level was set at .05. Stata software (version 11; StataCorp, College Station, TX) was used for all analyses.
Results
Of 9256 CHOICE participants, the first 5090 were observed for 3 years. In this cohort, 382 women were excluded because they did not start their chosen baseline method by the 3-month survey. There were a total of 4708 participants (92%) who were observed for 3 years and were included in this analysis. A flow diagram of included participants is shown in Figure 1. There were 185 women (4%) who were censored because of discontinuation for desire to conceive or pregnancy.
Demographic and reproductive characteristics are shown in Table 1. Mean age of participants in this analysis was 25 years; 48% were black; 35% had a high school education or less; 34% received public assistance; 44% had no health insurance; and 12% reported public insurance. Overall, 47% were nulliparous, and 66% reported at least 1 unintended pregnancy at baseline. There were 662 adolescents in our cohort: 405 used LARC methods and 257 used non-LARC methods. In our stratified analysis by LARC vs non-LARC methods, we noted that LARC users were older, had higher parity, were more likely to have public insurance, and were more likely to have a history of an unintended pregnancy.
Table 1Baseline characteristics of analytic sample, stratified by contraceptive method and age
Continuation at 1, 2, and 3 years for each contraceptive method is listed in Table 2. We stratified continuation by LARC and non-LARC methods. At 3 years, continuation was 67.2% among LARC users and 31.0% among non-LARC users (P < .001) (Figure 2). The highest continuation was among IUD users, with 69.8% continuation among LNG-IUD users and 69.7% among Cu-IUD users. Non-LARC methods had lower rates of continuation that range from 28–33% at 3 years. Among adolescents 14–19 years old, 3-year continuation was lower for all methods compared with women 20–45 years old and was lowest among non-LARC methods (52.6% for adolescents who used LARC and 23.1% for non-LARC methods). By 3 years, 54.6% of adolescents continued the LNG-IUD; 49.5% continued the Cu-IUD, and 50.8% continued the subdermal implant.
Table 2Kaplan-Meier estimates of 1-, 2-, and 3-year continuation of baseline method chosen
Variable
Continuation, % (95% confidence interval)
1 Year
2 Year
3 Year
Overall
76.7 (75.4–77.9)
64.2 (62.6–65.5)
56.2 (54.5–57.5)
Intrauterine device
Levonorgestrel
87.3 (85.8–88.6)
76.7 (74.8–78.5)
69.8 (67.6–71.8)
Copper
84.3 (80.7–87.3)
76.2 (72.1–79.9)
69.7 (65.1–73.7)
Implant
81.7 (78.3–84.7)
68.7 (64.7–72.3)
56.2 (51.8–60.3)
Depot medroxyprogesterone acetate
57.1 (51.6–62.3)
39.3 (33.8–44.7)
33.2 (26.9–37.7)
Oral contraceptive pill
60.6 (56.3–64.6)
42.2 (37.9–46.5)
31.5 (27.3–35.8)
Ring
54.3 (49.7–58.6)
37.5 (33.1–41.9)
30.0 (25.8–34.4)
Patch
48.2 (38.3–57.4)
35.0 (25.7–44.5)
28.4 (19.5–37.9)
Long-acting reversible contraceptive
85.8 (84.5–87.0)
75.2 (73.6–76.7)
67.2 (65.4–68.9)
Non-long-acting reversible contraceptive
55.8 (54.2–59.4)
39.5 (36.9–42.1)
31.0 (28.5–33.5)
Adolescents, 14–19 y
Long-acting reversible contraceptive
82.1 (78.0–85.6)
68.0 (63.0–72.5)
52.6 (47.2–57.7)
Non-long-acting reversible contraceptive
48.5 (42.1–54.6)
34.5 (28.5–40.6)
23.1 (17.6–29.0)
Adults, 20–45 y
Long-acting reversible contraceptive
86.3 (85.0–87.6)
76.2 (74.5–77.8)
69.2 (67.4–71.0)
Non-long-acting reversible contraceptive
58.6 (55.7–61.3)
40.5 (37.7–43.4)
32.6 (29.8–35.4)
Diedrich. Three-year contraceptive continuation. Am J Obstet Gynecol 2015.
Univariable analysis of risk factors for discontinuation is shown in Table 3; the multivariable model is shown in Table 4. After adjustment for age, race, education, low socioeconomic status, parity, and history of sexually transmitted infection, the hazard ratio for discontinuation was >3 times higher among non-LARC method users (adjusted hazard ratio, 3.08; 95% confidence interval, 2.80–3.39) than LARC users. Participants 14-19 years old at baseline were more likely to discontinue at 3 years compared with women ≥20 years old (adjusted hazard ratio, 1.33; 95% confidence interval, 1.16–1.53). Compared to those with a high school education or less, college graduates reported a lower risk of discontinuation (adjusted hazard ratio, 0.85; 95% confidence interval, 0.74–0.98).
Table 3Univariable analysis of risk factors for discontinuation of baseline contraceptive method at 3 years
Low socioeconomic status is defined as trouble paying for basic needs (food, housing, medical care, transportation) or receiving government aid (food stamps, welfare)
No
Reference
Yes
1.05
0.95–1.17
Parity
0
1.10
0.98–1.23
1+
Reference
History of sexually transmitted disease
No
Reference
Yes
1.21
1.10–1.34
Diedrich. Three-year contraceptive continuation. Am J Obstet Gynecol 2015.
a Low socioeconomic status is defined as trouble paying for basic needs (food, housing, medical care, transportation) or receiving government aid (food stamps, welfare)
Participants discontinued their baseline methods for a variety of reasons (Table 5). Of LNG-IUD users who discontinued this method, approximately 19% did so because of bleeding changes; 25% reported “I did not like how it made me feel.” The most common reasons for Cu-IUD users to stop their method was bleeding changes (35%) and cramping (17%). Forty-five percent of implant discontinuers reported bleeding changes; 28% reported that they did not like how they felt. Among non-LARC methods, 33% of DMPA users who stopped this method reported general side-effects as the most common reason for discontinuation. Forty-two percent of OCP users who discontinued reported logistical reasons, such as the pill being hard to remember to take or hard to get. Of patch discontinuers, 41% reported side-effects. Twenty-seven percent of women who discontinued the ring reported side-effects; 24% reported logistical issues.
Table 5Reasons for discontinuation of baseline contraceptive method in Contraceptive CHOICE Project
Continuation rates for LARC methods at 1, 2, and 3 years are significantly higher than non-LARC methods. After adjustment for confounding variables, the choice of a shorter-acting method and younger age were associated with increased discontinuation.
Teens 14–19 years of age were more likely to discontinue than women of ≥20 years old. However, of those adolescents who chose LARC methods, more than one-half were still using their method at 3 years compared with one-fifth of adolescents who were using their non-LARC methods at 3 years. Even among women who were using short-acting methods, 3-year continuation was relatively high. Those who used OCPs, DMPA, patch, and ring had continuation rates of 28–33%.
Relatively few previous studies have estimated continuation beyond 1 year among women in the United States who chose their contraceptive method rather than being randomly assigned to a method. Furthermore, this analysis was conducted with the data from the CHOICE cohort with a high follow-up rate in which only 19% of participants were lost to follow up at 3 years. Our cohort had continuation rates that were consistent with other prospective trials. The 70% continuation of both LNG- and Cu-IUDs was consistent with the previously reported 67–80%.
UNDP/UNFPA/WHO/World Bank IRG A randomized multicentre trial of the Multiload 375 and TCu380A IUDs in parous women: three-year results. UNDP/UNFPA/WHO/World Bank, Special Programme of Research, Development and Research Training in Human Reproduction: IUD Research Group.
A three-year comparative study of continuation rates, bleeding patterns and satisfaction in Australian women using a subdermal contraceptive implant or progestogen releasing-intrauterine system.
Eur J Contracept Reprod Health Care.2014; 19: 5-14
A three-year comparative study of continuation rates, bleeding patterns and satisfaction in Australian women using a subdermal contraceptive implant or progestogen releasing-intrauterine system.
Eur J Contracept Reprod Health Care.2014; 19: 5-14
It is very plausible that women who are interested in long-term (>2 years) protection from pregnancy are more likely to select IUDs and the implant; women who are less certain about their need or desire for long-term contraception would select non-LARC methods. However, we still believe our estimates of 3-year continuation are important for contraceptive counseling. High continuation rates reflect high satisfaction with LARC methods.
The major limitation of CHOICE is that it is a convenience sample within 1 geographic region. Participants were required to start or switch to a different contraceptive method at enrollment, which may also limit generalizability. An important consideration in this analysis is our assessment of 3-year continuation of the subdermal implant. This may be an inappropriate cut-off to measure continuation and satisfaction if women undergo implant removal because of the approaching “expiration” of the device at 3 years (the Food and Drug Administration-approved duration of use).
Another limitation is that data on side-effects, continuation, and expulsion were self-reported through phone follow up instead of at clinic visits.
Regardless of age, sociodemographic markers, and education, women who use LARC methods report high continuation rates at 3 years. OCPs and condoms continue to be the reversible contraceptive methods most commonly used by women in the United States.
It is time for a paradigm shift: LARC methods should be considered first-line contraceptives for women of all ages, given that satisfaction, continuation, and effectiveness have been shown to be superior to non-LARC methods.
Daniels K, Daugherty J, Jones J. Current contraceptive status among women aged 15 -44: United States, 2011 -2013. NCHS data brief, no 173. Hyattsville, MD: National Center for Health Statistics. 2014.
A randomized multicentre trial of the Multiload 375 and TCu380A IUDs in parous women: three-year results. UNDP/UNFPA/WHO/World Bank, Special Programme of Research, Development and Research Training in Human Reproduction: IUD Research Group.
A three-year comparative study of continuation rates, bleeding patterns and satisfaction in Australian women using a subdermal contraceptive implant or progestogen releasing-intrauterine system.
Eur J Contracept Reprod Health Care.2014; 19: 5-14
The Contraceptive CHOICE Project is funded by an anonymous foundation . This publication also was supported by Washington University Institute of Clinical and Translational Sciences grant number UL1 TR000448 from the National Center for Advancing Translational Sciences and award number K23HD070979 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development , National Institutes of Health .
J.F.P. receives research funding/support from Bayer , Teva , and Merck and serves on advisory boards for Teva Pharmaceuticals and MicroCHIPs; T.M. serves on an advisory board for Bayer Healthcare Pharmaceuticals and a data safety monitoring board for phase 4 safety studies of Bayer contraceptive products; the remaining authors report no conflict of interest.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Cite this article as: Diedrich JT, Zhao Q, Madden T, et al. Three-year continuation of reversible contraception. Am J Obstet Gynecol 2015;213:662.e1-8.