Expert Commentary
Webcast: Factors that contribute to overall contraceptive efficacy and risks
In this webcast Dr. Burkman compares perfect and typical use failure rates of the 2 most popular forms of contraception, OCs and condoms, with...
Dr. Creinin is Professor and Director of Family Planning, Department of Obstetrics and Gynecology, University of California, Davis, Sacramento.
Dr. Schimmoeller is a Fellow, Family Planning, Department of Obstetrics and Gynecology, University of California, Davis, Sacramento.
Dr. Creinin reports receiving grant or research support (all of which goes to the Department of Obstetrics and Gynecology, University of California, Davis) from ContraMed, Medicines360, Merck & Co., and the National Institutes of Health/Eunice Kennedy Schriver National Institute of Child Health and Human Development. He reports being a consultant to Allergan, Danco, Estetra, Femasys, HRA Pharma, Lemonaid Health, Medicines360, and Merck & Co. and is a speaker for Allergan and Merck & Co.
Dr. Schimmoeller reports no financial relationships relevant to this article.
Both EC methods are effective, broadening options
All women who received the copper IUD followed up at 2 weeks, and no pregnancies were reported. Of the women who received oral LNG EC plus the LNG IUS, 107 (97%) had follow-up at 2 weeks. In this group, there was 1 reported ectopic pregnancy that ultimately required surgical management. However, further review of the patient's coital history suggested that conception occurred prior to IUD insertion, and the case was not classified by the investigators as an EC failure.
Although this study was not powered to detect pregnancy rate differences between the traditional copper IUD and the oral LNG EC plus LNG IUS combination, the results are promising. An important strength of this study is the presence of 2 high-risk groups for EC failure in the oral LNG EC plus LNG IUS group (elevated BMI and multiple episodes of unprotected intercourse).
What this evidence means for practiceEncounters for EC are important opportunities in which to discuss a woman’s reproductive goals. For women who are interested in an IUD, this study opens up the option of same-day placement of the LNG 52-mg IUS. While larger trials need to be conducted to obtain more information regarding pregnancy rates with an oral EC plus LNG IUS combination versus the TCu380A, offering such a combination is reasonable. Given that ulipristal acetate (UPA) is a more effective EC product, especially for women who are overweight or obese,9 offering a UPA EC plus LNG IUS combination may be a better alternative.
Provider concerns regarding the presence of pelvic infection remain a significant barrier to same-day IUD insertion. Older studies suggested a higher risk of pelvic infection in the first 20 days after IUD placement and extrapolated that pelvic infection was related to inserting an IUD in a woman at risk for STI.10 As a result, patients may be restricted from same-day IUD insertion by providers who think that obtaining results of STI testing is required prior to placement. Recently, a systematic review suggested, based on limited evidence, that IUD placement does not increase the risk of pelvic infection in asymptomatic women compared with those without an IUD.11
Turok and colleagues (including M.D.C., coauthor of this article) reported results from a planned secondary analysis of A Comprehensive Contraceptive Efficacy and Safety Study of an IUS (ACCESS IUS), a component of the regulatory approval of the Liletta LNG 52-mg IUS. This analysis represents the first large-scale prospective investigation of pelvic infection rates during the first 2 years after IUD placement in US women.
Of the 1,751 women enrolled in the study, 1,714 had successful IUS insertions. Infection was assessed via baseline pelvic visual and bimanual examination and Chlamydia testing in all women. Gonorrhea testing was also performed in women who had not been tested with their current sexual partner. STI test results were not required for IUS insertion. Participants were assessed in person at 1, 3, 6, 12, and 24 months after insertion. Additional pelvic exams were performed as needed based on reported symptoms. At 6 months, 1 year, and 2 years, IUS continuation was reported in 1,553 (90.6%), 1,401 (81.7%), and 1,157 (67.3%) women, respectively.
Nearly all women received baseline STI testing (98.4%); however, results were not available prior to same-day IUS insertion for 79.6% of participants. Twenty-nine (1.7%) women had positive baseline STI tests (25 for Chlamydia, 3 for gonorrhea, 1 for both). Of these, only 6 women had results available prior to IUS placement. All women with a positive STI test were treated, and the IUS was left in place. Importantly, none of these women developed pelvic infection in the subsequent 2 years of follow-up and none requested IUS removal.
Among women with negative baseline STI tests, there were only 9 (0.5%) clinical diagnoses of pelvic infections over the first 2 years of follow-up. Diagnosis was typically made based on physical examination findings. Most women underwent repeat Chlamydia and gonorrhea testing at the time of pelvic infection diagnosis, and none had positive results. There were no medically recommended IUS removals; 2 women with pelvic infection requested IUS removal per their preference.
Three of the 9 women with pelvic infections were diagnosed within 1 week of IUS placement, 1 at 39 days after placement, and the remaining 5 more than 6 months after placement, suggesting that pelvic infection is not temporally related to IUS placement. Most women were successfully treated as outpatients.
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