Association Between Menorrhagia and Risk of Intrauterine Device-Related Uterine Perforation and Device Expulsion: Results from the APEX-IUD Study

dc.contributor.authorGetahun, Darios
dc.contributor.authorFassett, Michael J.
dc.contributor.authorGatz, Jennifer
dc.contributor.authorArmstrong, Mary Anne
dc.contributor.authorPeipert, Jeffrey F.
dc.contributor.authorRaine-Bennett, Tina
dc.contributor.authorReed, Susan D.
dc.contributor.authorZhou, Xiaolei
dc.contributor.authorSchoendorf, Juliane
dc.contributor.authorPostlethwaite, Debbie
dc.contributor.authorShi, Jiaxiao M.
dc.contributor.authorSaltus, Catherine W.
dc.contributor.authorWang, Jinyi
dc.contributor.authorXie, Fagen
dc.contributor.authorChiu, Vicki Y.
dc.contributor.authorMerchant, Maqdooda
dc.contributor.authorAlabaster, Amy
dc.contributor.authorIchikawa, Laura E.
dc.contributor.authorHunter, Shannon
dc.contributor.authorIm, Theresa M.
dc.contributor.authorTakhar, Harpreet S.
dc.contributor.authorRitchey, Mary E.
dc.contributor.authorChillemi, Giulia
dc.contributor.authorPisa, Federica
dc.contributor.authorAsiimwe, Alex
dc.contributor.authorAnthony, Mary S.
dc.contributor.departmentRegenstrief Institute, School of Medicineen_US
dc.date.accessioned2022-05-12T17:28:12Z
dc.date.available2022-05-12T17:28:12Z
dc.date.issued2022
dc.description.abstractBackground Intrauterine devices are effective contraception, and one levonorgestrel-releasing device is also indicated for treatment of heavy menstrual bleeding (menorrhagia). Objective To compare the incidence of intrauterine device expulsion and uterine perforation in women with and without a diagnosis of menorrhagia within the 12 months before device insertion. Study Design Retrospective cohort study conducted in 3 integrated healthcare systems (Kaiser Permanente Northern California, Southern California, and Washington) and a healthcare information exchange (Regenstrief Institute) in the United States, using electronic health records. Nonpostpartum women aged ≤50 years with intrauterine device (e.g., levonorgestrel or copper) insertions from 2001–2018 without a delivery in the prior 12 months were studied in this analysis. Recent menorrhagia diagnosis (i.e., recorded ≤12 months before insertion) was ascertained from International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification codes. Study outcomes—device expulsion and device-related uterine perforation (complete or partial)—were ascertained from electronic medical records and validated in data sources. Cumulative incidence and crude incidence rates with 95% confidence intervals were estimated. Cox proportional hazards models estimated crude and adjusted hazard ratios using propensity score overlap weighting (13-16 variables) and 95% confidence intervals. Results Among 228,834 nonpostpartum women, mean age was 33.1 years, 44.4% were White, and 31,600 (13.8%) had a recent menorrhagia diagnosis. Most women had a levonorgestrel-releasing device (96.4% of those with and 78.2% of those without a menorrhagia diagnosis). Women with a menorrhagia diagnosis were likely to be older, obese, and have dysmenorrhea or fibroids. Women with vs. without a menorrhagia diagnosis had a higher intrauterine device expulsion rate (40.01 vs. 10.92 per 1,000 person-years), especially evident in the few months after insertion. Women with a menorrhagia diagnosis had higher cumulative incidence (95% confidence interval) of expulsion (7.00% [6.70%, 7.32%] at 1 year, 12.03% [11.52%, 12.55%] at 5 years) vs. without (1.77% [1.70%, 1.84%] at 1 year, 3.69% [3.56%, 3.83%] at 5 years). Risk of expulsion was increased for women with a menorrhagia diagnosis vs. without (adjusted hazard ratio, 2.84 [95% confidence interval: 2.66, 3.03]). Perforation rate was low overall (<1/1,000 person-years) but higher in women with a diagnosis of menorrhagia vs. without (0.98 vs. 0.63 per 1,000 person-years). Cumulative incidence (95% confidence interval) of uterine perforation was slightly higher for women with a menorrhagia diagnosis (0.09% [0.06%, 0.14%] at 1 year, 0.39% [0.29%, 0.53%] at 5 years) vs. without (0.07% [0.06%, 0.08%], at 1 year, 0.28% [0.24%, 0.33%] at 5 years). Risk of perforation was slightly increased in women with a menorrhagia diagnosis vs. without (adjusted hazard ratio, 1.53; 95% confidence interval, 1.10, 2.13). Conclusion The risk of expulsion is significantly higher in women with a recent diagnosis of menorrhagia. Patient education and counseling regarding potential expulsion risk is recommended at insertion. The absolute risk of perforation for women with a recent diagnosis of menorrhagia is very low. Increased expulsion and perforation rates observed are likely due to causal factors of menorrhagia.en_US
dc.eprint.versionAuthor's manuscripten_US
dc.identifier.citationGetahun, D., Fassett, M. J., Gatz, J., Armstrong, M. A., Peipert, J. F., Raine-Bennett, T., Reed, S. D., Zhou, X., Schoendorf, J., Postlethwaite, D., Shi, J. M., Saltus, C. W., Wang, J., Xie, F., Chiu, V. Y., Merchant, M., Alabaster, A., Ichikawa, L. E., Hunter, S., … Anthony, M. S. (2022). Association Between Menorrhagia and Risk of Intrauterine Device-Related Uterine Perforation and Device Expulsion: Results from the APEX-IUD Study. American Journal of Obstetrics and Gynecology. https://doi.org/10.1016/j.ajog.2022.03.025en_US
dc.identifier.issn0002-9378en_US
dc.identifier.urihttps://hdl.handle.net/1805/28969
dc.language.isoenen_US
dc.publisherScienceDirecten_US
dc.relation.isversionof10.1016/j.ajog.2022.03.025en_US
dc.relation.journalAmerican Journal of Obstetrics and Gynecologyen_US
dc.rightsPublisher Policyen_US
dc.sourceAuthoren_US
dc.subjectalgorithmen_US
dc.subjectdata linkageen_US
dc.subjectelectronic health recordsen_US
dc.titleAssociation Between Menorrhagia and Risk of Intrauterine Device-Related Uterine Perforation and Device Expulsion: Results from the APEX-IUD Studyen_US
dc.typeArticleen_US
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