Browsing by Author "Gatz, Jennifer"

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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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    Association of the Timing of Postpartum Intrauterine Device Insertion and Breastfeeding With Risks of Intrauterine Device Expulsion
    (American Medical Association, 2022-02-01) Armstrong, Mary Anne; Raine-Bennett, Tina; Reed, Susan D.; Gatz, Jennifer; Getahun, Darios; Schoendorf, Juliane; Postlethwaite, Debbie; Fassett, Michael J.; Peipert, Jeffrey F.; Saltus, Catherine W.; Merchant, Maqdooda; Alabaster, Amy; Zhou, Xiaolei; Ichikawa, Laura; Shi, Jiaxiao M.; Chiu, Vicki Y.; Xie, Fagen; Hunter, Shannon; Wang, Jinyi; Ritchey, Mary E.; Chillemi, Giulia; Im, Theresa M.; Takhar, Harpreet S.; Pisa, Federica; Asiimwe, Alex; Anthony, Mary S.; Obstetrics and Gynecology, School of Medicine
    Importance: Intrauterine device (IUD) expulsion increases the risk of unintended pregnancy; how timing of postpartum IUD insertion and breastfeeding are associated with risk of expulsion is relevant to the benefit-risk profile. Objective: To evaluate the association of postpartum timing of IUD insertion and breastfeeding status with incidence and risk of IUD expulsion. Design, setting, and participants: The Association of Perforation and Expulsion of Intrauterine Devices (APEX-IUD) cohort study included women aged 50 years or younger with an IUD insertion between 2001 and 2018. The breastfeeding analysis focused on a subcohort of women at 52 or fewer weeks post partum with known breastfeeding status. The study was conducted using data from electronic health records (EHRs) at 4 research sites with access to EHR: 3 Kaiser Permanente sites (Northern California, Southern California, Washington) and the Regenstrief Institute (Indiana). Data analysis was conducted from June to November 2019. Exposures: Timing of IUD insertion post partum was categorized into discrete time periods: 0 to 3 days, 4 days to 6 or fewer weeks, more than 6 weeks to 14 or fewer weeks, more than 14 weeks to 52 or fewer weeks, and non-post partum (>52 weeks or no evidence of delivery). Breastfeeding status at the time of insertion was determined from clinical records, diagnostic codes, or questionnaires from well-baby visits. Main outcomes and measures: Incidence rates and adjusted hazard ratios (aHRs) were estimated using propensity scores to adjust for confounding. Results: The full cohort included 326 658 women (mean [SD] age, 32.0 [8.3] years; 38 911 [11.9%] Asian or Pacific Islander; 696 [0.2%] Hispanic Black; 56 180 [17.2%] Hispanic other; 42 501 [13.0%] Hispanic White; 28 323 [8.7%] non-Hispanic Black; 137 102 [42.0%] non-Hispanic White), and the subcohort included 94 817 women. Most IUDs were levonorgestrel-releasing (259 234 [79.4%]). There were 8943 expulsions. The 5-year cumulative incidence of IUD expulsion was highest for insertions 0 to 3 days post partum (10.73%; 95% CI, 9.12%-12.61%) and lowest for insertions more than 6 weeks to 14 or fewer weeks post partum (3.18%; 95% CI, 2.95%-3.42%). Adjusted HRs using women with non-post partum IUD insertion as the referent were 5.34 (95% CI, 4.47-6.39) for those with postpartum insertion at 0 to 3 days; 1.22 (95% CI, 1.05-1.41) for those with postpartum insertion at 4 days to 6 or fewer weeks; 1.06 (95% CI, 0.95-1.18) for those with postpartum insertion at more than 6 to 14 or fewer weeks; and 1.43 (95% CI, 1.29-1.60) for those with postpartum insertion at more than 14 to 52 or fewer weeks. In the subcohort, 5-year cumulative incidence was 3.49% (95% CI, 3.25%-3.73%) for breastfeeding women and 4.57% (95% CI, 4.22%-4.95%) for nonbreastfeeding women; the adjusted HR for breastfeeding vs not breastfeeding was 0.71 (95% CI, 0.64-0.78). Conclusions and relevance: In this study of real-world data, IUD expulsion was rare but more common with immediate postpartum insertion. Breastfeeding was associated with lower expulsion risk.
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    Demographic, Reproductive, and Medical Risk Factors for Intrauterine Device Expulsion
    (Wolters Kluwer, 2022-12) Anthony, Mary S.; Zhou, Xiaolei; Schoendorf, Juliane; Reed, Susan D.; Getahun, Darios; Armstrong, Mary Anne; Gatz, Jennifer; Peipert, Jeffrey F.; Raine-Bennett, Tina; Fassett, Michael J.; Saltus, Catherine W.; Ritchey, Mary E.; Ichikawa, Laura; Shi, Jiaxiao M.; Alabaster, Amy; Wahdan, Yesmean; Wang, Jinyi; Xie, Fagen; Merchant, Maqdooda; Hunter, Shannon; Chiu, Vicki Y.; Postlethwaite, Debbie; Rothman, Kenneth J.; Im, Theresa M.; Chillemi, Giulia; Takhar, Harpreet S.; Asiimwe, Alex; Pisa, Federica; Obstetrics and Gynecology, School of Medicine
    Objective: To explore to what extent intrauterine device (IUD) expulsion is associated with demographic and clinical risk factors. Methods: The APEX-IUD (Association of Perforation and Expulsion of IntraUterine Devices) study was a U.S. cohort study using electronic health records from three integrated health care systems (Kaiser Permanente Northern California, Southern California, and Washington) and a health care information exchange (Regenstrief Institute). These analyses included individuals aged 50 years or younger with IUD insertions from 2001 to 2018. Intrauterine device expulsion cumulative incidence and incidence rates were estimated. Using Cox regression models, hazard ratios with 95% CIs were estimated before and after adjustment for risk factors of interest (age, race and ethnicity, parity, body mass index [BMI], heavy menstrual bleeding, and dysmenorrhea) and potential confounders. Results: In total, 228,834 individuals with IUD insertion and no delivery in the previous 52 weeks were identified (184,733 [80.7%] with levonorgestrel-releasing intrauterine system). Diagnosis of heavy menstrual bleeding-particularly a diagnosis in both recent and past periods-was the strongest risk factor for IUD expulsion. Categories with the highest risk of IUD expulsion within each risk factor included individuals diagnosed with overweight, obesity, and morbid obesity; those in younger age groups, especially among those aged 24 years or younger; and in those with parity of four or more. Non-Hispanic White individuals had the lowest incidence and risk, and after adjustment, Asian or Pacific Islander individuals had the highest risk. Dysmenorrhea was not independently associated with expulsion risk when adjusting for heavy menstrual bleeding. Conclusion: Most risk factors for expulsion identified in this study appear consistent with known physiologic factors that affect uterine anatomy and physiology (age, BMI, heavy menstrual bleeding, parity). The increased risk of IUD expulsion among individuals of color warrants further investigation. Intrauterine devices are an effective long-term contraceptive; expulsion is uncommon, but patients should be counseled accordingly.
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    Risks of Uterine Perforation and Expulsion Associated With Intrauterine Devices
    (Wolters Kluwer, 2023) Fassett, Michael J.; Reed, Susan D.; Rothman, Kenneth J.; Pisa, Federica; Schoendorf, Juliane; Wahdan, Yesmean; Peipert, Jeffrey F.; Gatz, Jennifer; Ritchey, Mary E.; Armstrong, Mary Anne; Raine-Bennett, Tina; Postlethwaite, Debbie; Getahun, Darios; Shi, Jiaxiao M.; Xie, Fagen; Chiu, Vicki Y.; Im, Theresa M.; Takhar, Harpreet S.; Wang, Jinyi; Anthony, Mary S.; Obstetrics and Gynecology, School of Medicine
    Objective: The APEX-IUD (Association of Perforation and Expulsion of Intrauterine Devices) study evaluated the association of postpartum timing of intrauterine device (IUD) insertion, breastfeeding, heavy menstrual bleeding, and IUD type (levonorgestrel-releasing vs copper) with risks of uterine perforation and IUD expulsion in usual clinical practice. We summarize the clinically important findings to inform counseling and shared decision making. Methods: APEX-IUD was a real-world (using U.S. health care data) retrospective cohort study of individuals aged 50 years and younger with IUD insertions between 2001 and 2018 and with electronic health record data. Cumulative incidences of uterine perforation and IUD expulsion were calculated. Adjusted hazard ratios (aHRs) and 95% CIs were estimated from proportional hazards models with control of confounding. Results: Among the study population of 326,658, absolute risk of uterine perforation was low overall (cumulative incidence, 0.21% [95% CI 0.19-0.23%] at 1 year and 0.61% [95% CI 0.56-0.66% at 5 years]) but was elevated for IUDs inserted during time intervals within 1 year postpartum, particularly among those between 4 days and 6 weeks postpartum (aHR 6.71, 95% CI 4.80-9.38), relative to nonpostpartum insertions. Among postpartum insertions, IUD expulsion risk was greatest for insertions in the immediate postpartum period (0-3 days after delivery) compared with nonpostpartum (aHR 5.34, 95% CI 4.47-6.39). Postpartum individuals who were breastfeeding had a slightly elevated risk of perforation and lowered risk of expulsion than those not breastfeeding. Among nonpostpartum individuals, those with a heavy menstrual bleeding diagnosis were at greater risk of expulsion than those without (aHR 2.84, 95% CI 2.66-3.03); heavy menstrual bleeding also was associated with a slightly elevated perforation risk. There was a slightly elevated perforation risk and slightly lower expulsion risk associated with levonorgestrel-releasing IUDs compared with copper IUDs. Conclusion: Absolute risk of adverse outcomes with IUD insertion is low. Clinicians should be aware of the differences in risks of uterine perforation and expulsion associated with IUD insertion during specific postpartum time periods and with a heavy menstrual bleeding diagnosis. This information should be incorporated into counseling and decision making for patients considering IUD insertion.