A prospective assessment of pelvic infection risk following same-day sexually transmitted infection testing and levonorgestrel intrauterine system placement

doi:10.1016/j.ajog.2016.05.017

American Journal of Obstetrics and Gynecology

Volume 215, Issue 5, November 2016, Pages 599.e1-599.e6

Presented in part as an oral abstract at the International Federation of Gynecology and Obstetrics 2015 Congress, Vancouver, British Columbia, Canada, Oct. 4–9, 2015.

https://doi.org/10.1016/j.ajog.2016.05.017 Get rights and content

Background

Misperceptions persist that intrauterine device placement is related to pelvic infections and Chlamydia and gonorrhea testing results are needed prior to placement.

Objective

We sought to evaluate the relationship of Chlamydia and gonorrhea screening to pelvic infection for up to 2 years following placement of the levonorgestrel 52-mg intrauterine system.

Study Design

A total of 1751 nulliparous and multiparous females 16 to 45 years old enrolled in a multicenter trial designed to evaluate the efficacy and safety of a new levonorgestrel intrauterine system for up to 7 years. Participants had Chlamydia screening at study entry and yearly if they were age ≤25 years. Women also had baseline gonorrhea screening if testing had not been performed since starting their current sexual relationship. Those who changed sexual partners during the trial had repeated Chlamydia and gonorrhea testing. Intrauterine system insertion could occur on the same day as screening. Participants did not receive prophylactic antibiotics for intrauterine system placement. Investigators performed pelvic examinations after 12 and 24 months and when clinically indicated during visits at 3, 6, and 18 months after placement and unscheduled visits. Pelvic infection included any clinical diagnosis of pelvic inflammatory disease or endometritis.

Results

Most participants (n = 1364, 79.6%) did not have sexually transmitted infection test results available prior to intrauterine system placement. In all, 29 (1.7%) participants had positive baseline testing for a sexually transmitted infection (Chlamydia, n = 25; gonorrhea, n = 3; both, n = 1); 6 of these participants had known results (all with Chlamydia infection) prior to intrauterine system placement and received treatment before enrollment. The 23 participants whose results were not known at the time of intrauterine system placement received treatment without intrauterine system removal and none developed pelvic infection. The incidence of positive Chlamydia testing was similar among those with and without known test results at the time of intrauterine system placement (1.9% vs 1.5%, respectively, P = .6). Nine (0.5%) participants had a diagnosis of pelvic infection over 2 years after placement, all of whom had negative Chlamydia screening on the day of or within 1 month after intrauterine system placement. Infections were diagnosed in 3 participants within 7 days, 1 at 39 days, and 5 at ≥6 months. Seven participants received outpatient antibiotic treatment and 2 (diagnoses between 6–12 months after placement) received inpatient treatment. Two (0.1%) participants had intrauterine system removal related to infection (at 6 days and at 7 months after placement), both of whom only required outpatient treatment.

Conclusion

Conducting Chlamydia and gonorrhea testing on the same day as intrauterine system placement is associated with a low risk of pelvic infection (0.2%). Over the first 2 years of intrauterine system use, infections are infrequent and not temporally related to intrauterine system placement. Pelvic infection can be successfully treated in most women with outpatient antibiotics and typically does not require intrauterine system removal. Women without clinical evidence of active infection can have intrauterine system placement and sexually transmitted infection screening, if indicated, on the same day.

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 Gynecology
Same-day placement of long-acting reversible contraceptives, occurring when the device is requested and placed within a single visit, reduces barriers to the patient and reduces unintended pregnancies. Despite the safety and efficacy of same-day placement, access to same-day services remains low.
This study aimed to evaluate the effects of the Delaware Contraceptive Access Now initiative, a statewide initiative in Delaware focused on increasing same-day access to effective contraception on same-day receipt of long-acting reversible contraceptives.
We used Medicaid claims and encounter data to identify instances of same-day and multivisit receipts of long-acting reversible contraceptives among Medicaid-enrolled individuals in Delaware and Maryland aged 15–44 years who were covered in a full-benefits or family planning Medicaid aid category during the month of the placement and the 2 previous months. We used a difference-in-differences design that compared changes in the outcome from before to after implementation of the initiative among placements at agencies that participated in the initiative (n=6676) vs 2 alternative comparison groups: placements at Delaware agencies that did not participate (n=688) and placements in Maryland (n=35,847).
We found that the intervention was associated with a 13.3 percentage point increase (95% confidence interval, 1.9%–24.7%) in receipt of same-day long-acting reversible contraceptives using a nonparticipating Delaware comparison group, a 21.1 percentage point increase (95% confidence interval, 13.7%–28.6%) using a Maryland comparison group, and a 21.0 percentage point increase (95% confidence interval, 14.1%–27.9%) using a pooled comparison group. The effects were larger for implants than intrauterine devices.
The Delaware Contraceptive Access Now initiative substantially increased the number of patients receiving long-acting reversible contraceptives through a single-visit encounter. Our findings suggested that coordinated interventions involving provider and staff training and capital investments that seed device stocking can increase the number of patients receiving same-day long-acting reversible contraceptives.
Intrauterine Devices and Sexually Transmitted Infection among Older Adolescents and Young Adults in a Cluster Randomized Trial
2021, Journal of Pediatric and Adolescent Gynecology
Citation 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
Provider misconceptions regarding intrauterine device (IUD) safety for adolescents and young women can unnecessarily limit contraceptive options offered; we sought to evaluate rates of Neisseria gonorrhoeae or Chlamydia trachomatis (GC/CT) diagnoses among young women who adopted IUDs.
Secondary analysis of a cluster-randomized provider educational trial.
Forty US-based reproductive health centers.
We followed 1350 participants for 12 months aged 18-25 years who sought contraceptive care.
The parent study assessed the effect of provider training on evidence-based contraceptive counseling.
We assessed incidence of GC/CT diagnoses according to IUD use and sexually transmitted infection risk factors using Cox regression modeling and generalized estimating equations.
Two hundred four participants had GC/CT history at baseline; 103 received a new GC/CT diagnosis over the 12-month follow-up period. IUDs were initiated by 194 participants. Incidence of GC/CT diagnosis was 10.0 per 100 person-years during IUD use vs 8.0 otherwise. In adjusted models, IUD use (adjusted hazard ratio [aHR], 1.31; 95% confidence interval [CI], 0.71-2.40), adolescent age (aHR, 1.28; 95% CI, 0.72-2.27), history of GC/CT (aHR, 1.23; 95% CI, 0.75-2.00), and intervention status (aHR, 1.12; 95% CI, 0.74-1.71) were not associated with GC/CT diagnosis; however, new GC/CT diagnosis rates were significantly higher among individuals who reported multiple partners at baseline (aHR, 2.0; 95% CI, 1.34-2.98).
In this young study population with GC/CT history, this use of IUDs was safe and did not lead to increased GC/CT diagnoses. However, results highlighted the importance of dual sexually transmitted infection and pregnancy protection for participants with multiple partners.
Conception rates in women desiring pregnancy after levonorgestrel 52 mg intrauterine system (Liletta®) discontinuation
2021, Contraception
Citation 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.
Evaluate reproductive function in nulligravid and gravid women after levonorgestrel 52 mg intrauterine system (IUS) discontinuation based on time to pregnancy.
We evaluated women participating in the ACCESS IUS multicenter, Phase 3, open-label clinical trial of the Liletta(®) levonorgestrel 52 mg IUS who discontinued the IUS within 60 months of use and desired pregnancy. Study staff contacted participants every three months after IUS discontinuation for up to 12 months to determine whether pregnancy occurred. We excluded women who opted to stop attempting to conceive before 12 months. We evaluated 12-month conception rates in participants 16–35 years at IUS placement, comparing dichotomous outcomes using Fisher’s exact test. We performed a multivariable analysis to assess the association of baseline characteristics, age at discontinuation, duration of IUS use, and positive sexually transmitted infection testing during IUS use with conception.
Among 165 women who attempted to conceive, 142 (86.1%) did so within 12 months with a median time to conception of 92 days. The 12-month conception rates did not differ between nulligravid (66/76 [86.8%]) and gravid (76/89 [85.4%]) women (p = 0.83) and nulliparous (78/90 [86.7%]) and parous (64/75 [85.3%]) women (p = 0.83). In multivariable analysis, only obesity (aOR 0.3 [95% CI 0.1–0.8]) was associated with ability to conceive.
After levonorgestrel 52 mg IUS discontinuation, women have rapid return of fertility in the year post-removal. Fertility rates after IUS removal do not vary based on gravidity, parity, age at discontinuation, or duration of IUS use.
This contemporary IUS study included a large population of nulligravid and nulliparous women. IUS use over many years does not effect spontaneous fertility after IUS discontinuation, regardless of gravidity or parity. Providers and patients should have no concern about the impact of IUS use on future fertility.
Follow-up and counselling after pelvic inflammatory disease: CNGOF and SPILF Pelvic Inflammatory Diseases Guidelines
2019, Gynecologie Obstetrique Fertilite et Senologie
Déterminer les modalités du suivi après une infection génitale haute (IGH) et les conseils à donner à la patiente.
Une recherche bibliographique a été réalisée à partir des mots clés décrivant le suivi après IGH de 1990 à 2018 dans les bases de données Cochrane, PubMed et Google. Toutes les études publiées en langue française ou anglaise pertinentes ont été considérées. Les données ont été décrites avec un niveau de preuve, de façon à établir un grade de recommandations.
La fréquence des récidives des infections génitales hautes (IGH) est de 15 à 21 %. Elles sont liées à une réinfection par les bactéries des infections sexuellement transmissibles (IST) dans 20 à 34 % des cas et augmentent le risque d’infertilité et de douleurs pelviennes chroniques (NP2). Un suivi est recommandé après IGH (grade C). Le taux de perdues de vue est de l’ordre de 40 %. La compliance au suivi est améliorée par un rappel individualisé des patientes (grade B). Un examen microbiologique par un test d’amplification des acides nucléiques sur prélèvement vaginal de contrôle 3 à 6 mois après le traitement d’une IGH associée aux IST est recommandé pour éliminer une infection persistante ou une réinfection (grade C). L’utilisation des préservatifs est recommandée dans les suites d’une IGH associée à une IST afin de réduire le risque de récidives et de séquelles (grade C). La prescription des contraceptifs oraux au décours d’une IGH ne peut être recommandée dans le seul but de réduire le risque de douleurs ou d’infertilité. La pose d’un DIU n’est pas contre-indiquée après un épisode d’IGH, mais doit être précédée d’un prélèvement vaginal à la recherche d’une IST chez les femmes à risque (grade B). Les femmes qui souhaitent concevoir après une IGH doivent être averties du risque de grossesse extra-utérine et des signes cliniques qui doivent faire consulter.
L’information des patientes et les examens microbiologiques réalisés au cours du suivi diminuent le risque d’IST et donc de récidives d’IGH.
To determine the procedures for follow-up and counselling of patients after pelvic inflammatory disease (PID).
A search in the Cochrane database, PubMed, and Google was performed using keywords related to follow-up and PID to identify reports published between 1990 and 2018. All studies published in French and English relevant to the areas of focus were included. A level of evidence (LE) based on the quality of the data available was applied for each area of focus and used for the guidelines.
The rate of recurrent PID is 15 to 21%. They are related to a recurrent sexually transmitted infection (STI) in 20 to 34% of cases. Recurrence PID increase the risk of infertility and chronic pelvic pain (LE2). Follow-up is recommended after PID (grade C). The rate of patients lost to follow-up is around 40%. Follow-up is improved by personalized text message reminders (grade B). Vaginal sampling for detection of N. gonorrhoeae, C. trachomatis, (and M. genitalium) by nucleic acid amplification techniques is recommended 3 to 6 months after treatment of PID associated with STI to rule out possible reinfections (grade C). The use of condoms after PID associated with STI is recommended to reduce the risk of recurrences (grade C). The systematic use of contraceptive pills after PID is not recommended to prevent subsequent infertility and chronic pelvic pain. Vaginal sampling for microbiological diagnosis is recommended before the insertion of an intrauterine device (grade B). The risk of ectopic pregnancy is high in these women and must be kept in mind.
Patient counselling and microbiological testing after PID decrease the risk of STI and thus the recurrence of PID.
Increasing Accessibility to Long-Acting Reversible Contraception in a Public Health Setting
2018, Nursing for Women's Health
Citation 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).
To increase access to long-acting reversible contraception (LARC) by developing and implementing evidence-based criteria for LARC insertions at a public health clinic.
A quality improvement pilot project aimed at improving access to LARC for women of reproductive age and decrease associated costs.
Eligibility criteria for LARC at a public health clinic in rural Georgia required two clinic visits and unnecessary screening tests for women interested in these methods. These criteria limited eligibility of candidates who desired LARC, increased time between requests for and insertion of LARC, and increased costs.
Fifteen women of reproductive age who were uninsured or underinsured had a LARC inserted during project implementation.
The average number of days between visits based on the old (2007) criteria was compared with the average number of days between visits after implementation of the new (2017) criteria, with specific focus on the number of same-day LARC insertions. A secondary analysis of cost savings was calculated.
After implementation of the 2017 criteria, a statistically significant (p < .01) decrease in the mean number of days between request for and insertion of LARC was noted. Every woman who requested a LARC received it, and more than half of LARC insertions were provided the same day. Furthermore, the clinic noted savings of nearly $1,000 on LARC insertions.
The wait time for LARC insertion substantially decreased, and more than half of women had a LARC inserted the same day they requested it. By decreasing the wait time between request for and insertion of a LARC and implementing a policy to advocate for same-day insertion, use of the 2017 criteria decreased women’s risk for unintended pregnancy.
Use of intrauterine devices in nulliparous women
2017, Contraception
Five intrauterine devices (IUDs) are available in the United States: four levonorgestrel-releasing intrauterine systems (two containing 52 mg, one containing 19.5 mg and one containing 13.5 mg) and one copper-bearing device (Copper T 380A). All IUDs have very low typical-use failure rates and high acceptability ratings, yet they are used by a minority of women, with nulliparous women less likely to do so than parous women. The objective of this clinical review is to give evidence-based recommendations for the use of IUDs in nulliparous women. Intrauterine devices are safe and effective for the majority of women including those who are nulliparous, and should be routinely included in the contraception options offered to them.

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: 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.

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Original ResearchGynecologyA prospective assessment of pelvic infection risk following same-day sexually transmitted infection testing and levonorgestrel intrauterine system placement

Background

Objective

Study Design

Results

Conclusion

Introduction

Section snippets

Materials and Methods

Results

Comment

Acknowledgment

J Pediatr Adolesc Gynecol

Obstet Gynecol

Contraception

Contraception

Lancet

Contraception

Contraception

Contraception

Lancet

Contraception

Contraception

Contraception

Contraception

Contraception

Original Research
Gynecology
A prospective assessment of pelvic infection risk following same-day sexually transmitted infection testing and levonorgestrel intrauterine system placement