Browsing by Author "Ichikawa, Laura E."

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    Association Between Menorrhagia and Risk of Intrauterine Device-Related Uterine Perforation and Device Expulsion: Results from the APEX-IUD Study
    (ScienceDirect, 2022) Getahun, Darios; Fassett, Michael J.; Gatz, Jennifer; Armstrong, Mary Anne; Peipert, Jeffrey F.; Raine-Bennett, Tina; Reed, Susan D.; Zhou, Xiaolei; Schoendorf, Juliane; Postlethwaite, Debbie; Shi, Jiaxiao M.; Saltus, Catherine W.; Wang, Jinyi; Xie, Fagen; Chiu, Vicki Y.; Merchant, Maqdooda; Alabaster, Amy; Ichikawa, Laura E.; Hunter, Shannon; Im, Theresa M.; Takhar, Harpreet S.; Ritchey, Mary E.; Chillemi, Giulia; Pisa, Federica; Asiimwe, Alex; Anthony, Mary S.; Regenstrief Institute, School of Medicine
    Background 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.
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    Design of the Association of Uterine Perforation and Expulsion of Intrauterine Device study: a multisite retrospective cohort study
    (Elsevier, 2021) Anthony, Mary S.; Reed, Susan D.; Armstrong, Mary Anne; Getahun, Darios; Gatz, Jennifer L.; Saltus, Catherine W.; Zhou, Xiaolei; Schoendorf, Juliane; Postlethwaite, Debbie A.; Raine-Bennett, Tina; Fassett, Michael J.; Peipert, Jeffrey F.; Ritchey, Mary E.; Ichikawa, Laura E.; Lynen, Richard; Alabaster, Amy L.; Merchant, Maqdooda; Chiu, Vicki Y.; Shi, Jiaxiao M.; Xie, Fagen; Hui, Siu L.; Wang, Jinyi; Hunter, Shannon; Bartsch, Jennifer; Frenz, Ann-Kathrin; Chillemi, Giulia; Im, Theresa M.; Takhar, Harpreet S.; Asiimwe, Alex; Obstetrics and Gynecology, School of Medicine
    Background Intrauterine devices are effective and safe, long-acting reversible contraceptives, but the risk of uterine perforation occurs with an estimated incidence of 1 to 2 per 1000 insertions. The European Active Surveillance Study for Intrauterine Devices, a European prospective observational study that enrolled 61,448 participants (2006–2012), found that women breastfeeding at the time of device insertion or with the device inserted at ≤36 weeks after delivery had a higher risk of uterine perforation. The Association of Uterine Perforation and Expulsion of Intrauterine Device (APEX-IUD) study was a Food and Drug Administration–mandated study designed to reflect current United States clinical practice. The aims of the APEX-IUD study were to evaluate the risk of intrauterine device–related uterine perforation and device expulsion among women who were breastfeeding or within 12 months after delivery at insertion. Objective We aimed to describe the APEX-IUD study design, methodology, and analytical plan and present population characteristics, size of risk factor groups, and duration of follow-up. Study Design APEX-IUD study was a retrospective cohort study conducted in 4 organizations with access to electronic health records: Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and Regenstrief Institute in Indiana. Variables were identified through structured data (eg, diagnostic, procedural, medication codes) and unstructured data (eg, clinical notes) via natural language processing. Outcomes include uterine perforation and device expulsion; potential risk factors were breastfeeding at insertion, postpartum timing of insertion, device type, and menorrhagia diagnosis in the year before insertion. Covariates include demographic characteristics, clinical characteristics, and procedure-related variables, such as difficult insertion. The first potential date of inclusion for eligible women varies by research site (from January 1, 2001 to January 1, 2010). Follow-up begins at insertion and ends at first occurrence of an outcome of interest, a censoring event (device removal or reinsertion, pregnancy, hysterectomy, sterilization, device expiration, death, disenrollment, last clinical encounter), or end of the study period (June 30, 2018). Comparisons of levels of exposure variables were made using Cox regression models with confounding adjusted by propensity score weighting using overlap weights. Results The study population includes 326,658 women with at least 1 device insertion during the study period (Kaiser Permanente Northern California, 161,442; Kaiser Permanente Southern California, 123,214; Kaiser Permanente Washington, 20,526; Regenstrief Institute, 21,476). The median duration of continuous enrollment was 90 (site medians 74–177) months. The mean age was 32 years, and the population was racially and ethnically diverse across the 4 sites. The mean body mass index was 28.5 kg/m2, and of the women included in the study, 10.0% had menorrhagia ≤12 months before insertion, 5.3% had uterine fibroids, and 10% were recent smokers; furthermore, among these women, 79.4% had levonorgestrel-releasing devices, and 19.5% had copper devices. Across sites, 97,824 women had an intrauterine device insertion at ≤52 weeks after delivery, of which 94,817 women (97%) had breastfeeding status at insertion determined; in addition, 228,834 women had intrauterine device insertion at >52 weeks after delivery or no evidence of a delivery in their health record. Conclusion Combining retrospective data from multiple sites allowed for a large and diverse study population. Collaboration with clinicians in the study design and validation of outcomes ensured that the APEX-IUD study results reflect current United States clinical practice. Results from this study will provide valuable information based on real-world evidence about risk factors for intrauterine devices perforation and expulsion for clinicians.