American Journal of Obstetrics and Gynecology
Original ResearchGynecologyA prospective assessment of pelvic infection risk following same-day sexually transmitted infection testing and levonorgestrel intrauterine system placement
Introduction
Although the intrauterine device (IUD) is one of the most effective methods of reversible contraception,1 some health care providers remain concerned that IUD use increases the risk of pelvic infection.2, 3, 4 Misconceptions about IUD use and infection are entrenched in common practice throughout the world,5, 6 leading some providers to believe that infection risk is high and that sexually transmitted infection (STI) screening is needed prior to IUD placement.7 When providers require unnecessary tests for STI and make patients wait for IUD placement, barriers to effective contraception are created.
Research over the past 2 decades has begun to clarify the relationship among pelvic infection risk, STI, and IUD placement. Pelvic infection rates are very low among a screened population, including when the IUD is placed without test results.8, 9, 10, 11, 12 Even when Chlamydia or gonorrhea infection is present, the risk of pelvic infection is low with IUD insertion.13 Despite this evidence, we lack large, rigorously conducted, prospective trials performed in the United States with direct subject evaluation to evaluate pelvic infection rates shortly after and remote from insertion. Information from such studies can further elucidate risks and perhaps remove obstacles to immediate IUD insertion.
We recently reported the initial results of a Comprehensive Contraceptive Efficacy and Safety Study (ACCESS) of an intrauterine system (IUS) for regulatory approval of Liletta (Odyssea Pharma SPRL, Liège, Belgium; an Allergan affiliate).14 We conducted this large prospective study with the intent of IUS placement occurring with a same-day screen and insert model, meaning that participants would not have to wait for test results to return before IUS placement occurred. This report summarizes STI prevalence and pelvic infection rates in a large cohort of US women with multiple evaluations over a 2-year period.
Section snippets
Materials and Methods
This report represents a planned secondary analysis of data from the ACCESS IUS multicenter, phase III, open-label clinical trial of Liletta (Medicines360, San Francisco, CA; and Allergan, Irvine, CA), a levonorgestrel (LNG) 52-mg IUS. Details on the methods of this study have been reported previously.14 Briefly, investigators at 29 clinical sites in the United States invited healthy, nonpregnant, sexually active, nulliparous and parous females aged 16–45 years (inclusive) with regular
Results
Of the 1751 women enrolled, 1714 (97.9%) had successful placement and are included in this analysis. Demographic characteristics appear in Table 1. Overall, 1553 (90.6%), 1401 (81.7%), and 1157 (67.3%) participants continued IUS use at 6 months, 1 year, and 2 years, respectively.
Almost all women (n = 1687, 98.4%) had Chlamydia testing at screening (Table 2); the 27 missed tests included unsatisfactory specimens or protocol violations. These 27 participants all had successful IUS placements on
Comment
ACCESS IUS included a broad range of US women, more than half of whom were nulliparous. The trial allowed same-day IUS placement, meaning that providers could obtain STI testing at the time of IUS placement. Nearly 80% of participants had IUS placement without knowledge of STI testing results. Those with positive testing had STI treatment without the need for IUS removal, and no participant who had same-day placement and was then found to have a positive STI screen developed pelvic infection.
Acknowledgment
The authors thank Howard Hait for statistical assistance and the participating investigators and coordinators at the 29 study centers for conduct of the clinical trial and submission of data.
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Cited by (19)
Same-day long-acting reversible contraceptive utilization after a statewide contraceptive access initiative
2023, American Journal of Obstetrics and GynecologyIntrauterine Devices and Sexually Transmitted Infection among Older Adolescents and Young Adults in a Cluster Randomized Trial
2021, Journal of Pediatric and Adolescent GynecologyCitation Excerpt :Evidence on the biologic risk potential of the IUD includes a meta-analysis of randomized trials including more than 20,000 initiators, which showed no excess risk of PID among IUD users at low risk of STI, and identified only a small increased PID risk in the 20 days immediately post placement.18 More recent literature reports risk of PID at the time of IUD insertion as very small and unrelated to IUD placement with same-day STI testing in a clinical trial population,19 and that PID remains rare even with IUD placement during asymptomatic STI.20–22 The CDC Selected Practice Recommendations for Contraceptive Use and Medical Eligibility Criteria for Contraceptive Use support same-day STI screening without delaying IUD insertion among women with risk factors for STIs in the absence of purulent cervicitis or known chlamydial or gonorrheal infection.7,23,24
Conception rates in women desiring pregnancy after levonorgestrel 52 mg intrauterine system (Liletta®) discontinuation
2021, ContraceptionCitation Excerpt :The Liletta® levonorgestrel 52 mg intrauterine system (IUS) is approved for contraception for six continuous years based on results from the Phase 3 ACCESS IUS study, which is currently following women for up to 10 years of IUS use. The trial included 1714 women who received an IUS, of whom more than half had never had children, enabling the potential to follow a relatively large cohort of nulligravid and gravid women for return of fertility after IUS discontinuation [8]. In this report, we detail spontaneous conception rates among women from this study who desired pregnancy after IUS discontinuation.
Follow-up and counselling after pelvic inflammatory disease: CNGOF and SPILF Pelvic Inflammatory Diseases Guidelines
2019, Gynecologie Obstetrique Fertilite et SenologieIncreasing Accessibility to Long-Acting Reversible Contraception in a Public Health Setting
2018, Nursing for Women's HealthCitation Excerpt :Those considered high risk include women who are younger than 25 years and those with multiple sex partners (U.S. Preventive Services Task Force, 2014). However, it is reasonable to collect specimens for gonorrhea and chlamydia and insert the IUD on the same day; if the STI screening result is positive, a woman can be treated with the IUD in situ (Turok, Eisenberg, Teal, Keder, & Creinin, 2016). Same-day STI testing and IUD insertion does not increase the risk for pelvic inflammatory disease (Papic et al., 2014; Sufrin et al., 2012; Turok et al., 2016).
Use of intrauterine devices in nulliparous women
2017, Contraception
Supported by Medicines360.
Disclosure: Dr Turok receives speaking honoraria from Allergan and Medicines360; serves as a consultant for Bioceptive; and serves on advisory boards for Actavis, Bayer, Pharmanest, and Teva. The Department of Obstetrics and Gynecology, University of Utah, receives contraceptive clinical trials research funding from Bayer, Bioceptive, Medicines360, Teva, and Veracept. Dr Eisenberg receives speaking honoraria from Hologic and Merck & Co and serves on an advisory board for Medicines360. The Department of Obstetrics and Gynecology, Washington University School of Medicine in St Louis, receives contraceptive clinical trials research funding from Femasys and Medicines360. Dr Teal receives honoraria for service on a data safety and monitoring board for studies sponsored by Merck & Co and serves on advisory boards for Allergan and Bayer. The Department of Obstetrics and Gynecology, University of Colorado, receives contraceptive clinical trials research funding from Agile Therapeutics, Contramed, Medicines360, and Merck & Co. Dr Keder is a consultant to Bayer. The Department of Obstetrics and Gynecology, Ohio State University, receives research funding for contraceptive clinical trials from Agile Therapeutics and Medicines360. Dr Creinin receives speaking honoraria from Merck & Co; serves on advisory boards for Allergan, Evofem, Merck & Co, and Teva; and is a consultant for Danco, Femasys, HRA Pharma, Icebreaker Health, Medicines360, and Mithra. The Department of Obstetrics and Gynecology, University of California–Davis, receives research funding for contraceptive clinical trials from Contramed, Merck & Co, and Medicines360.
Cite this article as: Turok DK, Eisenberg DL, Teal SB, et al. A prospective assessment of pelvic infection risk following same-day sexually transmitted infection testing and levonorgestrel intrauterine system placement. Am J Obstet Gynecol 2016;215:599.e1-6.