By Rebecca H. Allen, MD, MPH

Assistant Professor, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants Hospital, Providence, RI

Dr. Allen reports she is a Nexplanon trainer for Merck and a Liletta trainer for Actavis, and she has served on advisory boards for Bayer and Pharmanest.

SYNOPSIS: In this prospective trial of same-day chlamydia/gonorrhea testing with intrauterine device insertion among 1,714 women, the risk of subsequent pelvic infection was extremely low (0.2%) over two years of follow-up.

SOURCE: 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; [Epub ahead of print].

This is a planned secondary analysis of a prospective, Phase III, multicenter clinical trial of a 52 mg levonorgestrel intrauterine device (IUD; Liletta) conducted in the United States.1 Investigators at 29 sites recruited women aged 16 to 45 years who desired levonorgestrel IUD for contraception. Women had to be monogamous upon enrolment but could switch sexual partners during the trial. Women were excluded if they had a history of pelvic inflammatory disease without intervening pregnancy, active cervical infection (cervicitis or known gonorrhea/chlamydia), or vaginal infection unless treated and resolved at least seven days before study entry. The trial was set up to conduct same-day sexually transmitted infection testing prior to IUD insertion. All tests were done with nucleic acid amplification testing on urine, vaginal, or cervical samples. All participants were screened for chlamydia (CT), and women who had not had gonorrhea (GC) testing since starting their current sexual relationship were tested. After IUD placement, women were followed at one, three, and six months and every six months thereafter to assess use of the IUD and changes in sexual partners. Women who reported a new sexual partner were screened for GC/CT.

Overall, 1,714 women with IUD placement were analyzed. Of these, 1,687 (98%) women underwent CT screening and 1,401 (81.7%) underwent GC screening. Most women underwent screening on the same day of insertion (79.6%), so results were not known in advance. Twenty-nine women (1.7%) had a positive test result (25 CT, 3 GC, 1 both), with only six knowing the results prior to insertion. All women with positive test results received outpatient antibiotic treatment per CDC guidelines and none had the IUD removed. Nine women (0.5%) had a pelvic infection diagnosed in two years of follow-up. All of these women had negative testing prior to IUD insertion. Of the pelvic infections, three were considered mild infections and six were considered severe infections. Seven women underwent outpatient treatment while two were treated in the hospital. The pelvic infection was diagnosed within seven days in three participants, at day 39 for one woman, and more than six months after insertion for the other five women.

COMMENTARY

The IUD is one of the most effective long-acting reversible contraceptives available, and efforts are underway to expand access to this method using a same-day approach: IUD insertion on the same day the patient presents requesting the device. Studies have shown that when patients are required to make several visits for IUD insertion, they often do not follow up for the insertion visit. Recommendations from the American College of Obstetricians and Gynecologists and the CDC do not require advance GC/CT testing for IUD insertion.2,3 When needed, GC/CT testing can be performed the same day as insertion. Nevertheless, despite these guidelines, some healthcare providers remain concerned about the chance of pelvic infection without advance testing before insertion.4 Although there are retrospective studies demonstrating that same-day testing with IUD insertion does not result in a higher incidence of pelvic infection compared to advanced testing,5 the authors conducted this secondary analysis to obtain prospective data.

Important findings from this study include the extremely low incidence of pelvic infection with the same-day testing protocol (0.5%). Women who had positive tests were successfully treated without IUD removal and none of these women developed pelvic infection. The nine women who developed pelvic infections all had negative tests prior to insertion. While in general, the study population was low risk for GC/CT, the rate of pelvic infection was similar to that seen in the Choice Contraception Study of 9,000 women (0.46%) in St. Louis County, MO.6 Another important finding from this study was that pelvic infection was not more common in the first three weeks after insertion compared to later periods, in contrast to the usual teaching. The original data demonstrating increased risk of infection in the first three weeks following placement came from a 1992 meta-analysis of 23,000 parous women from around the world (74% using copper IUD).7 The difference between these two studies may be that the international study population was not routinely screened for GC/CT before IUD insertion and/or there was a lower threshold for the diagnosis of pelvic infection during that time.

Overall, the data from this study support same-day testing and IUD insertion and should reassure providers regarding this practice. Women who are low risk for GC/CT do not even require testing prior to insertion.2 Women at higher risk can be screened the same day as IUD insertion. However, women who have obvious cervicitis or uterine tenderness on exam are not candidates for IUD insertion until after treatment. We have adopted this strategy in our clinical setting and it has worked well for all patients, especially those who don’t have the time or resources to return for multiple clinic visits.

REFERENCES

  1. Eisenberg DL, Schreiber CA, Turok DK, et al. Three year efficacy and safety of a new 52-mg levonorgestrel-releasing system. Contraception 2015;92:10-16.
  2. ACOG Committee Opinion No. 642: Increasing Access to Contraceptive Implants and Intrauterine Devices to Reduce Unintended Pregnancy. Obstet Gynecol 2015;126:e44-48.
  3. Centers for Disease Control and Prevention. US Selected Practice Recommendations for Contraceptive Use, 2013. Available at: http://www.cdc.gov/reproductivehealth/unintendedpregnancy/usspr.htm. Accessed May 31, 2016.
  4. Tyler CP, Whiteman MK, Zapata LB, et al. Health care provider attitudes and practices related to intrauterine devices for nulliparous women. Obstet Gynecol 2012;119;762-771.
  5. Sufrin CB, Postlethwaite D, Armstrong MA, et al. Neisseria gonorrhea and Chlamydia trachomatis screening at intrauterine device insertion and pelvic inflammatory disease. Obstet Gynecol 2012;120:1314-1321.
  6. Birgisson NE, Zhao Q, Secura GM, et al. Positive testing for Neisseria gonorrhoeae and Chlamydia trachomatis and the risk of pelvic inflammatory disease in IUD users. J Women’s Health 2015;24:354-359.
  7. Farley TM, Rosenberg MJ, Rowe PJ, et al. Intrauterine devices and pelvic inflammatory disease: An international perspective. Lancet 1992;339:785-788.