Abstract
BACKGROUND:
Same-day start removes barriers to contraceptive initiation and may reduce the risk of unintended pregnancy. It may be appropriate for all contraceptive methods, but we lack data comparing methods.
OBJECTIVE:
This study aimed to assess the frequency of same-day start with 6 contraceptive methods among new contraceptive users and describe the efficacy of same-day start in terms of first-cycle pregnancy risk overall and by each method.
STUDY DESIGN:
Using prospective data from the HER Salt Lake Contraceptive Initiative, we identified and assessed outcomes for participants initiating a new method of contraception beyond the first 7 days of their menstrual cycle (same-day start). Enrolled participants at 4 family planning clinics in Salt Lake County, Utah between September 2015 and March 2017 received their method of choice regardless of their cycle day or recent unprotected intercourse. All participants selfreported last menstrual period data and unprotected intercourse events in the previous 2 weeks. We excluded participants who received care immediately after or within 2 weeks of abortion care. Clinical electronic health records provided information on contraceptive method initiation and use of oral emergency contraception. Participants reported pregnancy outcomes in 1-, 3-, and 6-month follow-up surveys with clinic verification to identify any pregnancy resulting from same-day initiation. The primary outcomes report the frequency of same-day start use and first-cycle pregnancy risk among same-day start users of all contraceptive methods. The secondary outcomes include frequency of and pregnancy risk in the first cycle of use among same-day start contraception users by method. We also report the frequency of unprotected intercourse within 5 days and 6 to 14 days of contraception initiation, frequency of concomitant receipt of oral emergency contraception with initiation of ongoing contraception, and pregnancy risk with these exposures. We analyzed pregnancy risk for each contraceptive method initiated on the same day and assessed the simultaneous use of oral emergency contraception.
RESULTS:
Of the 3568 individuals enrolled, we identified most as same-day start users (n=2575/3568; 72.2%), with 1 in 8 of those reporting unprotected intercourse in the previous 5 days (n=322/2575; 12.5%) and 1 in 10 reporting unprotected intercourse 6 to 14 days before contraceptive method initiation (n=254/2575; 9.9%). We identified 11 pregnancies among same-day start users (0.4%; 95% confidence interval, 0.2–0.7), as opposed to 1 (0.1%; 95% confidence interval, 0.002–0.6) among those who initiated contraception within 7 days from the last menstrual period. Users of oral hormonal contraception and vaginal hormonal methods reported the highest first-cycle pregnancy rates (1.0–1.2). Among same-day start users, 174 (6.8%) received oral emergency contraception at enrollment in conjunction with another method. Among the same-day start users who received emergency contraception at initiation, 4 (2.3%) pregnancies were reported.
CONCLUSION:
Same-day start is common and associated with a low pregnancy risk. Using the “any method, any-time” approach better meets contraceptive clients’ needs and maintains a low risk of pregnancy.
Keywords: first-cycle pregnancy risk, quick start, same-day start
Introduction
Traditional approaches to initiation of contraceptive methods require starting the method within the first 7 days of the menstrual cycle.1 This means waiting for the next menstrual cycle to begin for those who are beyond the first 7 days. This clinical practice recommendation stems from a desire to avoid giving contraceptive hormones to patients at risk of a luteal-phase pregnancy, a situation in which a preimplantation fertilized ovum is not yet detectable by pregnancy testing.1,2 However, 20 years ago, researchers began to report the use of “quick start” or “same-day start” to describe the process of initiating a new method of birth control the same-day people present for care, regardless of their last menstrual period (LMP), including initiation beyond the first 7 days of the menstrual cycle.2 Because “same-day” start has become a more common search query and a more accurate descriptor than “quick start,” the term “same-day start” will be used in this article to signify receipt of contraception the same day the person presents for care beyond 7 days after the LMP. To reduce barriers to contraceptive access, including situations when urine pregnancy tests and emergency contraception (EC) are not available, the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) promote the use of a checklist titled, “How to be reasonably certain that a woman is not pregnant.” The checklist includes 6 items, beginning with the person being within 7 days from the start of normal menses. It also includes criteria addressing no recent intercourse, using a reliable method of contraception, being within 7 days of a spontaneous or induced abortion, within 4 weeks postpartum, or relying on lactational amenorrhea for contraception.1 However, individuals frequently initiate contraceptive use outside of these limited situations.
Previous studies assessing same-day start of individual contraceptive methods including oral contraception, the implant, medroxyprogesterone acetate injection, the CuT380A intrauterine device (IUD), and the levonorgestrel IUD uniformly report a low risk of pregnancy among same-day start user.2–10 Several analyses have demonstrated low risk of pregnancy even without meeting the above checklist criteria, suggesting that same-day start contraception may be considered regardless of pregnancy risk factors (eg, cycle timing, recent unprotected intercourse [UPI], and recent contraceptive practices).2–9 This “any method, any time” approach is becoming more common because it supports reproductive autonomy and removes several unsubstantiated barriers to contraceptive access (for example, the barrier of having to return for a second visit for many people desiring to start an IUD or implant who do not meet the CDC/WHO criteria). Providing same-day contraception is not only person-centered but can also reduce an individual’s risk of unintended pregnancy and may improve the likelihood that they obtain their desired method.11
Research so far lacks data assessing same-day start contraception efficacy in the first month of use across a variety of methods when the CDC pregnancy checklist criteria are not adhered to. In this study, we analyzed pregnancy risk by all contraceptive methods initiated among same-day start users, stratified by menstrual cycle (>7 days since LMP), recent contraceptive use, or recent report of UPI. We hypothesized a low risk of pregnancy in the first month of use regardless of cycle timing, recent UPI, and method type.
Materials and Methods
Study overview
Data from the prospectively enrolled cohort from the HER Salt Lake Contraceptive Initiative were analyzed.12 We enrolled new contraceptive clients between September 2015 and March 2017 at 4 Planned Parenthood Association of Utah (PPAU) health centers in Salt Lake County, Utah. We previously reported the project’s details, which we will briefly summarize here. Throughout the entire project, the staff used a standardized client-centered “contraceptive conversation” based on shared decision-making.13 This included semistructured, open-ended prompts addressing personal user preferences and a standardized handout focused on ease of use and effectiveness.
The project included a 6-month control period when usual care was provided at 3 Title X sites via a sliding cost scale. A fourth site focused on abortion care did not have Title X support but provided no-cost implants and IUDs through private donor support. During the 12-month intervention period between March 2016 and March 2017, the study protocol removed all out-of-pocket costs, including insurance co-pays. In addition, the project increased clinic staffing, assured adequate stocking of all contraceptive methods, and ensured clients’ ability to discontinue or switch selected methods for 3 years after initial care.
Following contraceptive method selection, health center staff trained in human participant research offered all clients receiving care during the study period participation in a 3-year prospective study. Enrolled participants provided informed consent when initiating a new contraceptive method facilitated by research-trained clinical assistants. The HER Salt Lake study was approved by the University of Utah Institutional Review Board (IRB #00065794).
Study population
Throughout the first 18 months of the project, participating sites provided contraception to 11,509 people in the all-served cohort. Of these, 4425 people enrolled in the 3-year prospective HER Salt Lake Contraceptive Initiative survey arm. We enrolled participants aged 18 to 45 years, fluent in English or Spanish, reporting a desire for pregnancy prevention for at least 1 year, with a working mobile phone, and an income under 300% of the federal poverty level.
We defined new contraceptive services as a new client seeking any contraceptive method or an existing client seeking a new contraceptive method. This analysis includes clients enrolled during the HER Salt Lake control and intervention periods. Clients interested in participating in the survey arm of the study completed the informed consent process and a baseline survey at the enrollment visit. Study participants provided data on previous contraceptive use, age, race, parity, socioeconomic characteristics, the date of their LMP, unprotected or underprotected intercourse during the last 2 weeks, and use of oral EC. Those reporting unprotected or underprotected intercourse 0 to 5 days before enrollment received EC.
We report the following contraceptive categories: the etonogestrel contraceptive implant, the copper T380A IUD, the levonorgestrel 52-mg IUD, medroxyprogesterone acetate injection, oral hormonal contraception, and combined vaginal hormonal contraception. The oral hormonal contraception category includes combined oral hormonal contraceptive pills and progesterone-only pill users, who only represent 5% of the group (50/970). We selected this grouping to include the progesterone-only pill users, who alone would not generate meaningful data.
After excluding 416 participants with missing LMP data, 366 who reported having an abortion in the last 6 weeks, 74 participants who selected barrier and/or rare methods (eg, diaphragm, patch), and 1 duplicate chart, our analytical sample consisted of 3568 participants. Among those excluded with missing LMP or barrier/rare methods, no pregnancies were reported at 1 month. Among this group, 7 of 416 (1.7%) pregnancies were reported at 3 or 6 months but none dated back to the first month of use.
To inform this analysis, we used both participant-reported pregnancy outcome data via phone or electronic follow-up surveys at 1, 3, and 6 months from September 2015 to March 2020, and electronic health records (EHRs) from PPAU and the 2 largest healthcare systems in the area. Reviewing pregnancy reporting out to 6 months enabled us to potentially identify any pregnancies that may have been back-dated to the first month for participants who did not complete the 1-month follow-up or had not identified pregnancy at the 1-month survey. Specifically, we reviewed the EHRs for any participant who reported a positive pregnancy test in the first 6 months (n=28/3568). The senior author (D.K.T.) reviewed the EHR to determine if the pregnancy was related to the initiation cycle and consistent with the predetermined definition of a same-day start failure. This included, on the basis of initial ultrasound findings, a pregnancy LMP date (±1 week of that reported at enrollment) or a calculated date of conception within 35 days of enrollment.
The primary outcomes included the frequency of same-day start of contraceptive use and first-cycle pregnancy risk of same-day start use among all contraceptive methods. The secondary outcomes included frequency of and the first-cycle pregnancy risk associated with same-day start use across the 6 contraceptive methods, frequency of UPI within 5 days and 6 to 14 days of contraception initiation, receipt of oral EC at enrollment, and pregnancy risk associated with these exposures. We also provide this information for non–same-day start users.
Statistical analysis
Statistical analyses were conducted using R, version 4.2.2 (R Core Team, Vienna, Austria). We conducted demographic summaries by same-day start status and assessed differences in distribution between same-day start statuses using 2-sample t-tests for numeric variables and chi-square tests for categorical variables. Furthermore, we assessed prevalence of UPI and subsequent pregnancy by method type and same-day start status. We compared pregnancy risk across all contraceptive methods among same-day start users and non–same-day start users, regardless of specific menstrual cycle day or current contraceptive use. UPI was categorized as occurring either 0 to 5 days before initiation or 6 to 14 days before initiation. We similarly assessed use of additional EC at initiation by contraceptive method chosen at enrollment. We excluded copper IUDs from the EC analysis because they did not need a separate oral method of EC. All instances of oral EC use reported herein involved 1.5-mg oral levonorgestrel.
Results
Among the 4425 participants enrolled in the HER Salt Lake survey arm, 3568 met the inclusion criteria. This included 2575 participants initiating a same-day start method and 993 initiating their method in the first 7 days of their menstrual cycle (non–same-day start group). The Figure illustrates the participant flowchart including exclusion criteria and the reason for exclusion. Table 1 details the baseline characteristics of participants included in the analysis and summarizes the 6 most common contraceptive methods selected by participants among both same-day start and non–same-day start groups. Of note, the oral hormonal contraceptive pills category includes 920 combined oral hormonal contraceptive pill users and 50 progesterone-only pill users. Of the progesterone-only pill users, 38 were same-day start initiators and 12 were non–same-day start. At initiation, half of the participants in the same-day start group underwent urine pregnancy tests, and those who did not receive pregnancy tests followed the clinical guidance for contraception initiation without a pregnancy test.
FIGURE. Patient selection and exclusion criteria and cohort population included in the analysis.
This figure shows the process of selection and exclusion criteria that was used for the analysis, including the final number of the cohort.
LMP, last menstrual period.
TABLE 1.
Demographic characteristics of HER Salt Lake participants by same-day start status
| Characteristic | Overall (N=3568a) | Non–same-day start (N=993a) | Same-day start (N=2575a) | P valueb |
|---|---|---|---|---|
| Method | .031 | |||
| Contraceptive implant | 669 (18.8%) | 201 (20.2%) | 468 (18.2%) | |
| CuT380A IUD | 446 (12.5%) | 118 (11.9%) | 328 (12.7%) | |
| Levonorgestrel 52-mg IUD | 829 (23.2%) | 247 (24.9%) | 582 (22.6%) | |
| Medroxyprogesterone acetate injection | 441 (12.4%) | 134 (13.5%) | 307 (11.9%) | |
| Oral hormonal contraception | 970 (27.2%) | 248 (25.0%) | 722 (28.0%) | |
| Combined vaginal hormonal contraception | 213 (6.0%) | 45 (4.5%) | 168 (6.5%) | |
| Age | 24.6 (5.4) | 24.7 (5.6) | 24.5 (5.3) | .5 |
| Race/ethnicity | .4 | |||
| White, non-Hispanic | 2,199 (62.5%) | 637 (65.3%) | 1562 (61.4%) | |
| Hispanic or Latina | 783 (22.3%) | 203 (20.8%) | 580 (22.8%) | |
| Asian | 117 (3.3%) | 27 (2.8%) | 90 (3.5%) | |
| Native Hawaiian or Pacific Islander | 39 (1.1%) | 9 (0.9%) | 30 (1.2%) | |
| American Indian or Alaska Native | 58 (1.6%) | 13 (1.3%) | 45 (1.8%) | |
| African American or Black | 62 (1.8%) | 14 (1.4%) | 48 (1.9%) | |
| Other | 260 (7.4%) | 72 (7.4%) | 188 (7.4%) | |
| Unknown | 50 | 18 | 32 | |
| Insurance status | .9 | |||
| None | 1658 (50.1%) | 458 (49.6%) | 1200 (50.3%) | |
| Medicaid or Medicare | 113 (3.4%) | 30 (3.3%) | 83 (3.5%) | |
| Private | 1540 (46.5%) | 435 (47.1%) | 1105 (46.3%) | |
| Unknown | 257 | 70 | 187 | |
| Income <100% of federal poverty level | 1399 (40.4%) | 382 (39.9%) | 1017 (40.6%) | .7 |
| Unknown | 106 | 35 | 71 | |
| Urine pregnancy test conducted at enrollment | 1637 (46.5%) | 367 (37.5%) | 1270 (50.0%) | <.001 |
| Unknown | 51 | 14 | 37 |
IUD, intrauterine device.
Number (percentage); mean (SD);
Pearson chi-square test; Welch 2-sample t-test.
Table 2 describes pregnancy risk and accounts for method initiated, same-day start status, and participant self-report of UPI at either 0 to 5 days or 6 to 14 days before initiation. This table also reports EC use at initiation. We identified 11 pregnancies among same-day start users (0.4%; 95% confidence interval [CI], 0.2–0.7), as opposed to 1 (prevalence: 0.1%; 95% CI, 0.002–0.6) pregnancy among those who initiated contraception within 7 days from the LMP. The greatest pregnancy risk occurred among oral contraceptive same-day start users (7/722; prevalence: 1.0%; 95% CI, 0.3–2.0). Of these, 1 was a progesterone-only pill user. One same-day start participant initiating medroxyprogesterone acetate injection reported a pregnancy that was determined to have occurred in the menstrual cycle when the study was initiated (0.03%; 95% CI, 0.05–1.8). The only pregnancy identified among all IUD and implant users occurred in a single same-day implant user (1/468; prevalence: 0.2%; 95% CI, 0.03–1.2). Overall, 717 of 3568 participants (20.1%) reported at least 1 episode of UPI in the 14 days before method initiation. Of note, there were 4 pregnancies (2.3%) among 174 same-day start users who also used oral EC of the 380 people who reported UPI in the 5 days preceding enrollment. This is consistent with previous reported EC failure rates and same-day start pregnancy rates among individuals receiving EC with contraception initiation.2,3,7,14,15
TABLE 2.
Self-reporting of unprotected intercourse 0 to 5 days and 6 to 14 days before initiation, emergency contraceptive use at initiation, and pregnancy outcomes stratified by method
| Characteristic | Contraceptive implant | CuT380A IUD | Levonorgestrel 52-mg IUD | Medroxyprogesterone acetate injection | Oral hormonal contraception | Combined vaginal hormonal contraception | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Non–same-day (n=201) | Same-day (n=468) | Non–same-day (n=118) | Same-day (n=328) | Non–same-day (n=247) | Same-day (n=582) | Non–same-day (n=134) | Same-day (n=307) | Non–same-day (n=248) | Same-day (n=722) | Non–same-day (n=45) | Same-day (n=168) | |
| UPI in previous 14 d | ||||||||||||
| None | 179 (89.1%) | 408 (87.2%) | 99 (83.9%) | 245 (74.7%) | 219 (88.7%) | 528 (90.7%) | 109 (81.3%) | 201 (65.5%) | 207 (83.5%) | 505 (69.9%) | 39 (86.7%) | 112 (66.7%) |
| UPI 0–5 d before | 9 (4.5%) | 28 (6.0%) | 11 (9.3%) | 55 (16.8%) | 9 (3.6%) | 22 (3.8%) | 14 (10.4%) | 71 (23.1%) | 20 (8.1%) | 113 (15.7%) | 4 (8.9%) | 33 (19.6%) |
| UPI 6–14 d before | 13 (6.5%) | 32 (6.8%) | 8 (6.8%) | 28 (8.5%) | 19 (7.7%) | 32 (5.5%) | 11 (8.2%) | 35 (11.4%) | 21 (8.5%) | 104 (14.4%) | 2 (4.4%) | 23 (13.7%) |
| Use of EC at same-day initiation | 0 (0.0%) | 16 (3.4%) | 0 (0.0%) | —a | 0 (0.0%) | 11 (1.9%) | 0 (0.0%) | 42 (13.7%) | 0 (0.0%) | 83 (11.5%) | 0 (0.0%) | 22 (13.1%) |
| Pregnancy in first month of use | ||||||||||||
| 0 (0.0%) | 1 (0.2%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (0.3%) | 1 (0.4%) | 7 (1.0%) | 0 (0.0%) | 2 (1.2%) | |
Data are reported as number (percentage).
EC, emergency contraception; IUD, intrauterine device; UPI, unprotected intercourse.
CuT380A IUD users do not require an additional oral method of EC; because we were unable to separately identify those who would have been treated as EC users, as was possible in the other groups, we did not report “use of EC at same-day initiation” for those who enrolled and reported UPI in the 5 preceding days.
Comment
Principal findings
This study found that pregnancy rates among same-day start contraceptive users are low across methods, with or without use of oral EC, and regardless of recent UPI.
Results in the context of what is known
The findings of our study should reassure healthcare providers and contraceptive clients that using same-day start or the “any method, any time” approach is safe and does not result in meaningfully different pregnancy outcomes. Our findings support the recent guidance that encourages healthcare providers to initiate a contraceptive method at any time, even in situations of uncertainty, with a follow-up pregnancy test in 2 to 4 weeks given that the benefits would likely exceed the risks.1 The risk of giving contraceptive hormones to patients at risk of luteal-phase pregnancy following the same-day protocol was low. Thus, providing the full range of contraceptive methods on the same day when people present for care better supports the needs and desires of contraceptive clients.
Clinical implications
Although most previous studies focused on same-day start of a specific contraception method,2–10 our study expands this to a more real-world setting, assessing outcomes for a variety of contraceptive methods. Our study results are consistent with the low pregnancy rates with same-day initiation of the contraceptive implant, levonorgestrel IUD, medroxyprogesterone acetate injection, and oral contraceptives.2–8
Research implications, unanswered questions, and proposals for future research
In addition to the results provided in this study, replication in other study settings is needed to better understand the pregnancy risks of same-day initiation across all contraceptive methods.
Strengths and limitations
Strengths of this analysis include multisite recruitment, a relatively large sample size with users in the same clinical care system, and a high rate of prospective follow-up with both user-reported outcomes and EHR confirmations. In addition, we compared data across different methods and reported the use of oral EC. Although our study had a large sample size, and surveys were designed with the intention of assessing same-day start use and outcomes, this remains a secondary analysis given that the primary outcome of the community-wide initiative was access and uptake and not pregnancy risk.
This study has several limitations. Although we crafted a systematic approach using multiple sites’ EHRs to conduct pregnancy follow-up, there may have been data on pregnancy that were missed if people moved out of state or sought care at an outside healthcare system. The low numbers of pregnancies among the different categories of contraceptive methods and the small numbers of participants in certain method groups precluded adequately powered analyses comparing pregnancy risk between groups. In addition, we did not have a comparator group for which this care was not provided because withholding care would be unethical and was thus impossible. However, pregnancy rates for such a group would likely be higher than what we observed for any subgroup in this analysis. The single-state (Utah) study location may limit generalizability; however, the county where the initiative occurred is more diverse than the state as a whole. Data on UPI and the use of a back-up method in the week following enrollment were not collected, which could influence the pregnancy outcomes at 1 month. Although we recognize that same-day start provided participants with the method that they wanted at the time when they wanted it, this article does not formally assess meeting patient need. Finally, this evaluation does not include all contraceptive methods (because of low uptake of certain methods, such as contraceptive patches), and sites did not provide permanent methods (tubal procedures and vasectomy).
Conclusions
Same-day start is common and results in low first-month pregnancy risk. The simplicity and user-centeredness of an “any-method, any-time” contraceptive approach outweighs the small increase in pregnancy risk and clinical burden in providing this type of care. Providers do not have to remember complicated initiation instructions or put additional burden on patients to remember (and report) exact LMP or recent incidences of UPI that might otherwise cause contraceptive methods to be withheld. Rather, they should combine their best clinical judgment with liberal use of EC, same-day provision of contraceptive methods, and any follow-up care necessary. Translating these findings into clinical care will support reproductive autonomy and potentially increase client satisfaction.
AJOG at a Glance.
Why was this study conducted?
This study aimed to assess the frequency of same-day start with 6 contraceptive methods and describe the efficacy of same-day start in terms of first-cycle pregnancy risk overall and by each method. We stratified data by recent report of unprotected intercourse and emergency contraception use.
Key findings
Most contraceptive initiators were same-day start users. They had a low pregnancy risk, similar to that of participants starting their method within 7 days of onset of menses.
What does this add to what is known?
The use of the “any method, any time” approach providing same-day contraception is person-centered. Immediately meeting the client’s contraceptive needs results in a low first-month risk of unintended pregnancy.
Acknowledgments
The authors acknowledge the exceptional work of the HER Salt Lake research team, which includes Corinne Sexsmith, Jasmin Alcantara, Eduardo Galindo, and Amy Orr. In addition, we gratefully acknowledge the clinical and research partnership of the Planned Parenthood Association of Utah and especially the people who received the care documented herein and generously shared their information with us.
The University of Utah’s ASCENT Center for Reproductive Health receives research funding from Bayer, CooperSurgical, Femasys, Medicines360, Organon, and Sebela Pharmaceuticals. D.K.T. is a consultant for Myovant Sciences and Sebela Pharmaceuticals, and has received support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Office of Research on Women’s Health of the National Institutes of Health (NIH) (Award Number K24HD087436). J.N.S. receives funding from the Agency for Healthcare Research and Quality (K01HS02722). The remaining authors report no conflict of interest. The content is solely the responsibility of the authors and does not necessarily represent the official view of any of the funding agencies or participating institutions, including the NIH, the University of Utah, or Planned Parenthood Federation of America, Inc.
This study was funded by the Society of Family Planning Research Fund, the William and Flora Hewlett Foundation, the Willard L. Eccles Foundation, the Intermountain Community Care Foundation, an anonymous foundation, and private contributions from community members. In addition, the following companies contributed contraceptive products for the project: Bayer Women’s Healthcare, Merck & Co, Inc (now Organon), and Teva Pharmaceuticals (now CooperSurgical). Additional support was provided by the University of Utah Population Health Research Foundation, with funding in part from the National Center for Research Resources and the National Center for Advancing Translational Sciences (NCATS), NIH, through Grant UL1TR002538 (formerly 5UL1TR001067-05, 8UL1TR000105, and UL1RR025 764). Use of REDCap was provided by 8UL1TR000105 (formerly UL1RR025764) NCATS/NIH.
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