Background: Intrauterine devices (IUDs) are highly effective contraceptives that have been underutilized in the United States. The copper IUD is well-studied and extremely effective as emergency contraception, and the US Centers for Disease Control (CDC) states that both the copper and hormonal IUDs may be initiated if a clinician can be reasonably certain that a woman is not pregnant. This ‘Quick Start’ approach to initiation regardless of menstrual cycle day has been well studied for hormonal contraceptives. However, there are few studies that assess outcomes for copper IUDs placed at any time and these have small sample sizes for insertions performed outside of menses. To our knowledge, no studies have examined outcomes following levonorgestrel intrauterine system (LNG-IUS) insertion at any time in the menstrual cycle.
Methodology: We enrolled women from two clinical sites: a Title X-funded clinic primarily serving low-income women, and a private practice predominantly serving college students and women with commercial insurance. Women were eligible to participate if they spoke English or Spanish, were willing to keep a daily bleeding diary, had cellular phones with text messaging functionality, and were receiving an IUD for contraceptive indications. IUDs included the copper T380A (ParaGard®, Teva Pharmaceuticals) and the levonorgestrel IUD (Mirena®, Bayer HealthCare Pharmaceuticals). Women having an IUD removal and reinsertion at a single visit were ineligible. Women enrolled in the study following completion of routine clinical services, including the IUD insertion. After informed consent, they completed a brief questionnaire about demographic characteristics, medical history, and past contraceptive use. The research coordinator called all participant cell phones to ensure they were in service.
We then randomized participants to report the presence or absence of bleeding and cramping each day for 90 days, by replying to daily text messages or by completing paper diaries and mailing these to the study center each month. We reviewed medical records for six months following IUD insertion to track reports of pregnancy, IUD expulsions and voluntary removals.
Findings: Two hundred thirty women enrolled, and randomization yielded groups similar in baseline characteristics. Eighty-seven of 119 (74%) copper IUD insertions occurred beyond cycle week one. Of these women, 36 were using a Tier I or Tier II contraceptive method (implants, injectables, pill, patch or ring), 28 were using condoms or withdrawal, 7 were not using contraception, and 16 were abstinent. The LNG-IUS was inserted beyond cycle week one for 89/111 women (80%). In this group, 32 were using Tier I or Tier II method, one had lactational amenorrhea, 25 were using condoms or withdrawal, 9 were not using contraception, and 22 were abstinent. We inserted IUDs in 102 (44%) women at some risk of pregnancy (not using a Tier I or II method and beyond cycle day 7), who would have been denied insertions by providers inserting IUDs only during the first week of the menstrual cycle.
Twenty percent of participants provided no bleeding data; of these, 77% were assigned to paper diaries. Approximately twenty percent in each group provided complete 90-day bleeding data. In the text group, the median response was 82 of 90 (IQR 40-89). In the paper group, the median response was 36 (IQR 0-88). The number of responses received decreased gradually over the 90-day period, but was always higher in the text group. Women who had attained higher levels of education did well regardless of data collection modality, while text messages response rates were greater among those with a high school education or less (p < 0.01). We identified one pregnancy in a participant with a presumed IUD expulsion. We observed a 92% continuation rate six months after IUD insertion. For the 54 women that received IUDs during cycle week one, there were two expulsions and six requests for IUD removal during the six-month follow-up period. Among the 125 women who had IUDs placed at any other time in the cycle, we observed five expulsions and eight voluntary removals. Of the 51 women for whom we could not determine a menstrual cycle day, one had an expulsion and five requested IUD removal. Conclusion: Same-day IUD insertion occurs safely throughout the menstrual cycle when clinicians are reasonably certain that women are not pregnant, following CDC guidelines. Participants reporting bleeding via text messages provided more complete data than women using paper diaries. Depending on resources and population of interest, text messages may be a useful modality to improve data collection for patient-reported outcomes.