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Risk of unintended pregnancy based on intended compared to actual contraceptive use Matthew F. Reeves, MD, MPH; Qiuhong Zhao, MS; Gina M. Secura, PhD, MPH; Jeffrey F. Peipert, MD, PhD
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 followup. 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, 1.8e3.3). Delaying initiation of IUC or implantable contraception increased unintended pregnancies by 60% (adjusted hazard ratio, 1.6; 95% confidence interval, 1.2e2.0). 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. Key words: continuation, contraception, injectable contraception,
unintended pregnancy
Introduction In clinical practice, a medical professional can only directly influence the contraceptive method that an individual patient initiates at that particular visit. Many patients subsequently stop using the initial contraceptive method without consulting a medical professional or change to a less effective method.1,2 By examining unintended pregnancy rates by the method chosen initially, we are able to examine the combined effects of the effectiveness and continuation of that method. More practically, with an analysis of intended use, we can examine the results after a patient leaves the medical professional’s office with a new contraceptive method.
Cite this article as: Reeves MF, Zhao Q, Secura GM, et al. Risk of unintended pregnancy based on intended compared to actual contraceptive use. Am J Obstet Gynecol 2016;215:71.e1-6. 0002-9378/free ª 2016 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ajog.2016.01.162
We are particularly interested in how injectable methods would perform in this analysis. Consensus has not been reached as to whether injectable contraception should be considered a long-acting reversible contraceptive (LARC) method. With perfect use, injectable contraceptives have contraceptive efficacy similar to intrauterine contraception (IUC) and implantable contraception,3 but in typical use, injectable contraception is more similar to oral contraception.4,5 Likewise, the continuation rate of injectable methods is more similar to oral contraception than IUC or implantable contraception.6 Internationally, LARC is defined as IUC and implantable contraception.7 However, the National Institute for Health and Care Excellence includes injectable contraceptive methods, such as depot medroxyprogesterone acetate (DMPA), as LARC.8 The Contraceptive CHOICE Project was a longitudinal cohort study of 9256 women who were provided with
no-cost, reversible contraception for 2-3 years.9,10 A prior analysis of contraceptive method use among CHOICE participants found that IUC and implantable contraception were 20 times more effective in preventing pregnancy during typical use than the contraceptive pill, patch, or ring.11 Women who were using DMPA were observed to have an unintended pregnancy rate that was similar to those using LARC methods. However, in that analysis women were only considered DMPA users if they received a DMPA injection in the past 3 months. Thus, the pregnancy risk for DMPA is closer to perfect use, and not comparable to the other methods reported. To examine real-world use of all methods used in the CHOICE Project and to better quantify pregnancy risk of the contraceptive method a woman or girl begins, this analysis estimates the risk of unintended pregnancy based on the initial method choice of each participant. For the intent-to-use (ITU) analysis, we grouped women by the
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method they chose and initiated regardless of subsequent switching or discontinuation. We then compared the results of the ITU analysis to an updated analysis of the previously reported pregnancy rates based on traditional astreated (termed “as-used” in this analysis) contraceptive effectiveness.11
Materials and Methods The CHOICE Project had 2 main objectives: (1) to promote the use of the most effective methods of reversible contraception (IUCs and implant); and (2) to assess the population impact of providing no-cost contraception to approximately 10,000
women in the St Louis region. Participants were provided reversible contraception of their choice at no cost, and were allowed to switch methods during their 2-3 years of follow-up. A prior publication provides a full description of the methods of the CHOICE Project.10
TABLE 1
Baseline characteristics of participants, by initial contraceptive method
Total
Total N (%)
Delayed N (%)
Hormonal IUC N (%)
Copper IUC N (%)
Implant N (%)
Injectable Oral N (%) N (%)
Patch N (%)
Ring N (%)
9252
2747
2462
713
1056
601
166
642
865
<.01
Age, y <20
1404 (15.2)
335 (31.7) 118 (19.6) 172 (19.9)
28 (16.9)
20e24
3535 (38.2) 1026 (37.3)
914 (37.1) 199 (27.9)
393 (37.2) 240 (39.9) 372 (43.0)
69 (41.6) 322 (50.2)
25e29
2436 (26.3)
758 (27.6)
698 (28.4) 222 (31.1)
200 (18.9) 132 (22.0) 217 (25.1)
48 (28.9) 161 (25.1)
30e39
1643 (17.8)
477 (17.4)
544 (22.1) 214 (30.0)
115 (10.9)
94 (15.6)
90 (10.4)
20 (12.0)
89 (13.9)
234 (2.5)
81 (2.9)
13 (1.2)
17 (2.8)
14 (1.6)
1 (0.6)
1 (0.2)
40
405 (14.7)
232 (9.4)
74 (3.0)
45 (6.3)
33 (4.6)
69 (10.7)
<.01
Parity 0
4350 (47.0) 1115 (40.6)
938 (38.1) 287 (40.3)
537 (50.9) 288 (47.9) 642 (74.2)
94 (56.6) 449 (69.9)
1
2260 (24.4)
753 (27.4)
650 (26.4) 152 (21.3)
263 (24.9) 139 (23.1) 136 (15.7)
44 (26.5) 123 (19.2)
2
1611 (17.4)
568 (20.7)
527 (21.4) 146 (20.5)
149 (14.1)
96 (16.0)
61 (7.1)
17 (10.2)
47 (7.3)
3
1031 (11.1)
311 (11.3)
347 (14.1) 128 (18.0)
107 (10.1)
78 (13.0)
26 (3.0)
11 (6.6)
23 (3.6) <.01
Unintended pregnancies 0
3398 (36.7)
877 (31.9)
749 (30.4) 233 (32.7)
421 (39.9) 207 (34.4) 496 (57.3)
65 (39.2) 350 (54.5)
1
2492 (26.9)
802 (29.2)
625 (25.4) 165 (23.1)
304 (28.8) 173 (28.8) 208 (24.0)
54 (32.5) 161 (25.1)
2
1551 (16.8)
509 (18.5)
471 (19.1) 132 (18.5)
156 (14.8) 104 (17.3)
92 (10.6)
19 (11.4)
68 (10.6)
3
1794 (19.4)
551 (20.1)
614 (24.9) 182 (25.5)
175 (16.6) 115 (19.1)
66 (7.6)
28 (16.9)
63 (9.8) <.01
Race Black
4669 (50.5) 1388 (50.5) 1199 (48.7) 269 (37.7)
651 (61.6) 448 (74.5) 370 (42.8)
99 (59.6) 245 (38.2)
White
3867 (41.8) 1150 (41.9) 1092 (44.4) 381 (53.4)
301 (28.5) 123 (20.5) 424 (49.0)
55 (33.1) 341 (53.1)
104 (9.8)
12 (7.2)
Others
P
715 (7.7)
209 (7.6)
171 (6.9)
63 (8.8)
30 (5.0)
71 (8.2)
55 (8.6) <.01
Education High school
3205 (34.7) 1023 (37.2)
764 (31.0) 186 (26.1)
546 (51.8) 283 (47.2) 227 (26.2)
52 (31.3) 124 (19.3)
Some college
3901 (42.2) 1155 (42.0) 1075 (43.7) 297 (41.7)
376 (35.6) 256 (42.7) 384 (44.4)
77 (46.4) 281 (43.8)
College
2143 (23.2)
37 (22.3) 237 (36.9)
569 (20.7)
622 (25.3) 230 (32.3)
133 (12.6)
Receiving public assistance
3440 (37.2) 1230 (44.8)
930 (37.8) 242 (34.0)
443 (42.0) 248 (41.3) 176 (20.3)
61 (10.2) 254 (29.4)
55 (33.3) 116 (18.1) <.01
History of STI
3745 (40.5) 1211 (44.1)
990 (40.2) 281 (39.4)
416 (39.4) 277 (46.1) 253 (29.3)
72 (43.4) 245 (38.2) <.01
Totals for some contraceptive methods do not add to 100% for unintended pregnancy and race due to missing values. copper IUC, copper T380A intrauterine contraceptive; hormonal IUC, levonorgestrel 52 mg intrauterine contraceptive; implant, etonogestrel 68 mg subdermal implant; injectable, depot medroxyprogesterone acetate 150 mg; oral, oral contraceptive; patch, transdermal contraceptive; ring, vaginal ring contraceptive; STI, sexually transmitted infection. Reeves et al. Risk of pregnancy by initial contraception choice. Am J Obstet Gynecol 2016.
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TABLE 2
Incidence of unintended pregnancy by contraceptive method Intent-to-use
As-used Cumulative Incidenceb
Cumulative incidenceb
Baseline method
Patients, Person- Unintended Person- Unintended n years pregnancies, n Ratea Year 1 Year 2 Year 3 years pregnancies, n Ratea Year 1 Year 2 Year 3
Overall
9252
20,017 615
3.1
2.7
5.9
9.1
20,318 380
1.9
2.4
3.3
4.2
LARC
4231
9246 176
1.9
1.5
3.6
5.9
13,877
40
0.3
0.3
0.6
0.8
Non-LARC
2274
4921 260
5.3
4.3
9.9
15.1
6441 340
5.3
5.5
8.3
11.2
Hormonal IUC 2462
5472 106
1.9
1.8
3.8
5.8
8534
19
0.2
0.2
0.4
0.7
Copper IUC
1563
1.7
1.2
3.1
5.1
2269
14
0.6
0.6
1.3
1.7
Implant
713
26
1056
2210
44
2.0
1.1
3.6
7.0
3074
7
0.2
0.3
0.5
0.5
Injectable
601
1237
68
5.5
2.4
8.9
17.9
1709
27
1.6
1.9
1.9
1.9
Oral
865
1838
97
5.3
4.5
10.5
14.4
2687 180
6.7
6.8
10.9
14.0
Patch
166
360
28
7.8
6.9
16.0
20.5
28
7.2
7.7
10.4
16.0
Ring
642
1487
67
4.5
5.0
8.4
12.7
1657 105
6.3
6.9
9.7
13.4
389
Women who delayed initiation of their chosen method are excluded from intent-to-use results in all rows except “overall.” copper IUC, copper T380A intrauterine contraceptive; hormonal IUC, levonorgestrel 52 mg intrauterine contraceptive; implant, etonogestrel 68 mg subdermal implant; injectable, depot medroxyprogesterone acetate 150 mg; LARC, long-acting reversible contraceptive (hormonal IUC, copper IUC, implant); non-LARC, non-long-acting reversible contraceptive (injectable, oral, patch, ring); oral, oral contraceptive; patch, transdermal contraceptive; ring, vaginal ring contraceptive. a
Pregnancies per 100 woman-years; b Pregnancies per 100 women. Reeves et al. Risk of pregnancy by initial contraception choice. Am J Obstet Gynecol 2016.
Inclusion criteria for CHOICE were: (1) female age 14-45 years; (2) residence in the St Louis region; (3) ability to speak English or Spanish; (4) interest in reversible contraception; (5) sexually active with a male partner in the past 6 months or anticipate sexual activity in the next 6 months; (6) no desire for pregnancy in the next year; and (7) interest in starting a new reversible contraceptive method. In the baseline interview, study staff collected comprehensive information on demographic characteristics and reproductive history. Participants were followed up with telephone interviews at 3 and 6 months and every 6 months thereafter. At each survey, we asked participants about contraceptive use, missed menses, and possible pregnancy. Specifically, we asked participants what contraceptive method(s) they used, if they had stopped using each method, and their start and stop dates. Any participant who thought she might be pregnant was asked to return for urine pregnancy testing. We estimated the conception date from the
date of the last menstrual period or by ultrasonography. We censored participants who were lost to follow-up at the time of their last completed interview. If a participant discontinued a method to conceive, we censored her when she stopped the method. For the ITU analysis, we sought to compare rates of unintended pregnancy by the contraceptive method chosen at baseline. To assess the practice of providing specific contraceptive methods at baseline, regardless of duration of use or change of method, we did not consider change of contraceptive method or method continuation in the ITU analysis. This analysis can be considered analogous to an intent-to-treat analysis for a randomized trial. However, in this case, each participant was able to choose which “treatment” to use. We grouped participants by baseline chosen method: intrauterine, implantable, injectable, oral, vaginal, or transdermal. Women who delayed initiation of IUC, implantable contraception, or injectable contraception until after the day of counseling or for >30 days for oral, transdermal, or
transvaginal contraception were considered to have a delayed start and analyzed separately. For the as-used contraceptive efficacy analysis, we categorized periods of contraceptive method use by each participant throughout study participation. Information about method start and stop dates was collected from 3 sources: scheduled telephone interviews; pharmacy data obtained from the partner pharmacy where participants obtained pills, patch, or ring; and the participant contraceptive-method log that documented when the participant initiated or discontinued use of a method or switched to another method (ie, insertion or removal of an IUC or implant; receipt of an initial pill supply, patch, or ring; and DMPA injection). A participant was considered to have used DMPA for the 16-week interval after a record of an injection, based on the World Health Organization recommendation.12 In the case of expulsion of an IUC, if the participant knew the device had fallen out and she became pregnant, the unintended pregnancy
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Results
TABLE 3
Hazard ratios for unintended pregnancy by contraceptive method Adjusteda
Intent-to-use
Unadjusted
Contraceptive method
Hazard ratio (95% CI)
Hazard ratio (95% CI)
Hormonal IUC
1.0
ref
1.0
ref
Copper IUC
0.9
(0.6e1.3)
1.0
(0.6e1.5)
Implant
1.0
(0.7e1.5)
0.8
(0.6e1.2)
Injectable
2.8
(2.1e3.9)
2.4
(1.8e3.3)
Oral
2.7
(2.1e3.6)
3.6
(2.7e4.7)
Patch
4.0
(2.6e6.1)
4.1
(2.7e6.2)
Ring
2.3
(1.7e3.1)
3.3
(2.4e4.5) a
As-used
Unadjusted
Adjusted
Contraceptive method
Hazard ratio (95% CI)
Hazard ratio (95% CI)
Hormonal IUC
1.0
ref
1.0
ref
Copper IUC
2.8
(1.4e5.6)
3.1
(1.5e6.2)
Implant
1.0
(0.4e2.4)
0.8
(0.4e2.0)
Injectable
5.5
(3.0e10.0)
4.5
(2.5e8.2)
Oral
24.6
(15.1e40.0)
28.0
Patch
25.1
(13.8e45.6)
22.8
(12.7e41.0)
Ring
24.2
(14.7e40.0)
31.3
(19.1e51.3)
(17.3e45.4)
Women who delayed initiation of their chosen method are excluded from intent-to-use analysis. CI, confidence interval; copper IUC, copper T380A intrauterine contraceptive; hormonal IUC, levonorgestrel 52 mg intrauterine contraceptive; implant, etonogestrel 68 mg subdermal implant; injectable, depot medroxyprogesterone acetate 150 mg; oral, oral contraceptive; patch, transdermal contraceptive; ring, vaginal ring contraceptive. a
Adjusted for age, prior unintended pregnancies, race, education, and public assistance. Reeves et al. Risk of pregnancy by initial contraception choice. Am J Obstet Gynecol 2016.
was attributed to “no method” (unless an alternative method was used). However, if the participant was unaware that the device had fallen out, the pregnancy was attributed to IUC failure. Contraceptive method failure was defined as conception that occurred during a period when the contraceptive method was used. If the participant reported she had stopped using the method, we categorized use as “no method” and the pregnancy was not considered a contraceptive method failure. We excluded conception that occurred after a participant stopped using a method owing to a desire to conceive (intended pregnancy). We used the c2 test to compare baseline demographic characteristics. We used Kaplan-Meier survival curves to estimate the cumulative incidence
rate at year 1, 2, and 3. We used Cox proportional hazards models to control for confounders in the final adjusted model. Confounding effect was defined as a >10% change in associations between contraceptive method and risk of unintended pregnancy with or without the potential confounding variable in the model. We used the levonorgestrel IUC as the referent group since this was the largest group in the CHOICE Project. The Washington University in St Louis School of Medicine Human Research Protection Office approved the CHOICE protocol before participant recruitment began and all study participants provided written informed consent (ClinicalTrials.gov identifier: NCT01986439). In this analysis LARC methods are defined as IUC and implantable contraception.
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During 20,017 person-years of followup, we identified 615 unintended pregnancies for a rate of 3.1 per 100 personyears. Of women, 65% were between ages 20-29 years; 50% were black; 35% had less than or equal to a high school education; 37% were receiving public assistance; 47% were nulliparous; 63% had a previous unintended pregnancy; and >40% had a previous sexually transmitted infection (Table 1). In Table 2, we provide the unintended pregnancy rates for the ITU and as-used analyses by contraceptive method. Women initiating LARC methods (IUCs or implants) had a pregnancy risk of 1.9 per 100 person-years, compared to 0.3 per 100 person-years in the as-used analysis. Women who began non-LARC methods (DMPA, pills, patch, ring) had a pregnancy rate of 5.3 per 100 personyears. Notably, the pregnancy rate among women initiating DMPA was 5.5 per 100 person-years. The hazard ratios for all methods are shown in Table 3 for ITU and as-used analyses. Time to unintended pregnancy is shown in the Figure. Among the women who did not receive their chosen IUC or implantable contraceptive method on the day of counseling, the risk of unintended pregnancy was increased by 60% (hazard ratio, 1.6; 95% confidence interval, 1.2e2.0) in both unadjusted and adjusted analyses, compared to women who initiated the hormonal IUC on the day of counseling. Of women who delayed the initiation of a LARC method, 1628 (74%) initiated IUC within 16 weeks of enrollment and 420 (82%) initiated implantable contraception within 16 weeks of enrollment.
Comment We found that IUC and implantable contraceptives were significantly more effective in both ITU and as-used analyses. We believe our findings from the ITU analysis provide practical information to health care providers counseling individual patients. These data present the risk of pregnancy for a woman or girl as she leaves the office with a given method. If anything, these data
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FIGURE
Kaplan-Meier graph of time to pregnancy
Y-axis shows probability of remaining without unintended pregnancy. A, Time to pregnancy by initial chosen contraceptive method (intent to use). Delayed long-acting reversible contraceptive (LARC [Hormonal intrauterine contraceptive, copper intrauterine contraceptive, implant]) includes all women who did not initiate intrauterine or implantable contraception on day of counseling. B, Time to pregnancy by contraceptive method used (as used). copper IUC, copper T380A intrauterine contraceptive; hormonal IUC, levonorgestrel 52 mg intrauterine contraceptive; implant, etonogestrel 68 mg subdermal implant; injectable, depot medroxyprogesterone acetate 150 mg; oral, oral contraceptive; patch, transdermal contraceptive; ring, vaginal ring contraceptive. Reeves et al. Risk of pregnancy by initial contraception choice. Am J Obstet Gynecol 2016.
underestimate the differences outside of a research project. Women in the CHOICE Project had access to no-cost contraception of their choosing throughout the study. Thus, a woman or girl discontinuing oral contraception had ready access to an IUC if she desired. The effect of this is apparent from the fact that in these data, women choosing oral contraceptives in the ITU analysis had a lower pregnancy rate than those who used oral contraceptives in the as-used analysis. In contrast, past research has found that many women stopping oral contraceptives choose a less effective method.1,13 The survival curves for nonLARC methods are very distinct when we compared the ITU analysis to the as-used analysis. The difference in the non-LARC survival curves reflects the variability in continuation rates and changes to more or less effective contraceptive methods. An important difference was observed between the 2 analyses for DMPA. In the as-used analysis, DMPA use was assumed to have stopped at 16 weeks after each injection, making the as-used results essentially perfect use for DMPA, although still significantly less
effective than the hormonal IUC. In contrast, women initiating DMPA in the ITU analysis had a pregnancy rate similar to those initiating oral contraceptives. Although in the first year after initiation of DMPA, women had a relatively lower pregnancy rate, the rate rose with time to be the second highest among the methods studied (Figure and Table 2). This finding is in contrast to the as-used analysis where no pregnancies occurred after the first year. We suspect that this divergence between the ITU and as-used analyses reflected self-sorting of women into those who like DMPA and were able to return for injection and those who did not like it and/or could not return. Although the ITU analysis includes those women who continued DMPA to 3 years, the pregnancy rate remains constant after the first year, likely due to substantial self-selection and discontinuation of DMPA by 12 months, with just 189 person-years in year 2 and 116 person-years in year 3. In comparison to the traditional asused effectiveness analysis,11 the differences between contraceptive method effectiveness are less pronounced in
the ITU analysis. For example, in the asused analysis, hormonal IUC use was found to be roughly 22-31 times more effective than oral contraceptives, the contraceptive patch, or ring. In the ITU analysis, IUC initiation was found to be just 3-4 times more effective than oral contraceptives. The reduced risk ratio can be attributed to switching from IUCs to less effective methods, or from switching from oral contraceptives to IUCs or an implant. Furthermore, for most individual methods, the absolute risk of pregnancy is much higher in the ITU analysis than the as-used analysis. For example, women who initiated injectable contraceptives had a pregnancy rate of 5.5 per 100 person-years in the ITU analysis compared to 1.6 per 100 person-years in the as-used analysis. The much lower apparent effectiveness shown in the ITU analysis is likewise attributable to women switching from injectable contraceptives to less effective methods or from high discontinuation rates with DMPA. We plan to examine switching patterns in future analyses of the CHOICE data. Generalizability of these data may be limited by the setting in which they
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were collected. Although LARC uptake was high and may reflect an ideal setting, it does not reflect the reality in many clinical settings. Increasing LARC uptake may require additional provider training, tier-based contraceptive counseling, and ensuring that methods are available for insertion on the day of counseling. It is important to note that women who did not initiate IUC or implantable contraception on the day of counseling were 60% more likely to have an unintended pregnancy. Providing contraception on the same day as counseling is feasible and increases uptake of these methods,14 and, as can be seen in the Figure, A, has an immediate effect in reducing unintended pregnancy. The risk of pregnancy after initiation of LARC methods is substantially lower than all other methods. These findings should encourage more health care providers to initiate IUCs and implants at the time of contraceptive counseling when patients choose these methods. Injectable contraception is no more effective in practice than oral contraceptives. n
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Author and article information From the National Abortion Federation, Washington, DC (Dr Reeves); Department of Population, Family, and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (Dr Reeves); and Division of Clinical Research, Department of Obstetrics and Gynecology, Washington University School of Medicine, St Louis, MO (Ms Zhao and Drs Secura and Peipert). Received Jan. 7, 2016; accepted Jan. 15, 2016. An anonymous foundation funded this work. The funder had no role in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the article for publication. M.F.R. serves as a consultant to ContraMed LLC. J.F.P. receives research support from Bayer and Teva. The other authors report no conflicts of interest. A preliminary analysis was presented as an abstract at the North American Forum on Family Planning, organized by the Society of Family Planning, in Miami, FL, Oct. 12-13, 2014. Corresponding author: Matthew F. Reeves, MD, MPH.
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