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Item Association between intrauterine device use and endometrial, cervical, and ovarian cancer: an expert review(Elsevier, 2023-08) Minalt, Nicole; Caldwell, Amy; Yedlicka, Grace M.; Joseph, Sophia; Robertson, Sharon E.; Landrum, Lisa M.; Peipert, Jeffrey F.; Obstetrics and Gynecology, School of MedicineThe intrauterine device is one of the most effective forms of contraception. Use of the intrauterine device has increased in the United States over the last 2 decades. Two formulations are commercially available in the United States: the levonorgestrel-releasing intrauterine device and the copper intrauterine device. The levonorgestrel intrauterine device releases progestin, causing endometrial suppression and cervical mucus thickening, whereas the primary mechanism of action of the copper intrauterine device is to create a local inflammatory response to prevent fertilization. Whereas the protective effects of combined hormonal contraception against ovarian and endometrial cancer, and of tubal sterilization against ovarian cancer are generally accepted, less is known about the effects of modern intrauterine devices on the development of gynecologic malignancies. The best evidence for a protective effect of intrauterine device use against cancer incidence pertains to levonorgestrel intrauterine devices and endometrial cancer, although studies suggest that both copper intrauterine devices and levonorgestrel intrauterine devices reduce endometrial cancer risk. This is supported by the proposed dual mechanisms of action including both endometrial suppression and a local inflammatory response. Studies on the relationship between intrauterine device use and ovarian cancer risk show conflicting results, although most data suggest reduced risk of ovarian cancer in intrauterine device users. The proposed biological mechanisms of ovarian cancer reduction (foreign-body inflammatory response, increased pH, antiestrogenic effect, ovulation suppression) vary by type of intrauterine device. Whereas it has been well established that use of copper intrauterine devices confers a lower risk of cervical intraepithelial neoplasms, the effect of levonorgestrel intrauterine device use on cervical cancer remains unclear. Older studies have linked its use to a higher incidence of cervical dysplasia, but more recent literature has found a decrease in cervical cancer with intrauterine device use. Various mechanisms of protection are postulated, including device-related inflammatory response in the endocervical canal and prostaglandin-mediated immunosurveillance. Overall, the available evidence suggests that both levonorgestrel intrauterine devices and copper intrauterine devices reduce gynecologic cancer risk. Whereas there is support for the reduction of endometrial cancer risk with hormonal and copper intrauterine device use, and reduction of cervical cancer risk with copper intrauterine device use, evidence in support of risk reduction with levonorgestrel intrauterine device use for cervical and ovarian cancers is less consistent.Item Comparison of Unintended Pregnancy at 12 Months between Two Contraceptive Care Programs; a Controlled Time-Trend Design(Elsevier, 2019) Madden, Tessa; Paul, Rachel; Maddipati, Ragini; Buckel, Christina; Goodman, Melody; Peipert, Jeffrey F.; Obstetrics and Gynecology, School of MedicineObjectives To compare unintended pregnancy rates at 12 months between women receiving structured contraceptive counseling plus usual contraceptive care and women receiving structured contraceptive counseling, healthcare provider education and cost support for long-acting reversible contraceptive (LARC) methods. Study design Using a controlled time-trend study design, we first enrolled 502 women receiving structured contraceptive counseling in addition to usual care (“Enhanced Care”) and subsequently enrolled 506 women receiving counseling plus healthcare provider education and cost support for LARC methods (“Complete CHOICE”) at three federally qualified health centers (FQHCs). Cost support included funds to health centers for “on-the-shelf” LARC methods and no-cost LARC methods for uninsured women. Participants completed in-person baseline surveys and follow-up surveys by telephone at 3, 6 and 12 months. We used Kaplan–Meier survival function to estimate 12-month unintended pregnancy rates and Cox proportional-hazards regression to compare unintended pregnancy rates between the two groups. We imputed pregnancy outcomes for women lost to follow-up (9%) prior to 12 months. Results “Complete CHOICE” participants were less likely to report an unintended pregnancy at 12 months compared to “Enhanced Care”; 5.3 vs. 9.8 pregnancies per 100 women-years (p=.01). After adjusting for confounders (recruitment site, race, age and federal poverty level), women in “Complete CHOICE” had a 40% lower risk of unintended pregnancy at 12 months (adjusted hazard ratio 0.60; 95% confidence interval 0.37–0.99). Conclusions Contraceptive provision that includes cost support and healthcare provider education in addition to patient counseling reduced unintended pregnancy at 12 months compared to counseling plus usual contraceptive care. Implications A program of contraceptive care that includes comprehensive counseling; healthcare provider education; cost support; and on-the-shelf, long-acting reversible contraception can reduce unintended pregnancy compared to contraceptive counseling in addition to usual health center care in the FQHC setting.Item Effect of Staff Training and Cost Support on Provision of Long-Acting Reversible Contraception in Community Health Centers(Elsevier, 2019) Buckel, Christina; Maddipati, Ragini; Goodman, Melody; Peipert, Jeffrey F.; Madden, Tessa; Obstetrics and Gynecology, School of MedicineObjective To compare the proportion of women receiving same-day long-acting reversible contraception (LARC) between two different models of contraceptive provision adapted from the Contraceptive CHOICE Project. Study Design We used a controlled time-trend study design to compare 502 women receiving structured contraceptive counseling in addition to usual care (“Enhanced Care”) to 506 women receiving counseling plus healthcare provider education and cost support for LARC (“Complete CHOICE”) at three federally qualified health centers. We provided funds to health centers to ensure an “on-the-shelf” supply and no-cost LARC for uninsured women. We recorded the contraceptive method chosen after contraceptive counseling and the healthcare provider appointment as well as the contraceptive method received that day. Among women choosing LARC, we calculated proportions and performed Poisson regression with robust error variance to estimate relative risks for same-day insertion. Results Participant demographics reflected the health center populations; 69% were black, 66% had a high school diploma or less, 57% were publicly insured, and 75% reported household income less than 101% federal poverty line. There were 153 (30.5%) women in “Enhanced Care” and 273 (54.0%) in “Complete CHOICE” who chose LARC (p<0.01). Among women who chose LARC (n=426), those in “Complete CHOICE” were more likely to receive a same-day insertion, 53.8% vs. 13.7% (RRadj 4.73; 95%CI 3.20-6.98) compared to “Enhanced Care.” Conclusions A contraceptive care model that included healthcare provider education and cost support for LARC in addition to structured contraceptive counseling resulted in higher rates of same-day LARC insertion compared to contraceptive counseling and usual care alone.Item Intrauterine device use, sexually transmitted infections, and fertility: a prospective cohort study(Elsevier, 2021-08) Peipert, Jeffrey F.; Zhao, Qiuhong; Schreiber, Courtney; Teal, Stephanie; Turok, David K.; Natavio, Melissa; Cordon, Sabrina; Daggy, Joanne; Obstetrics and Gynecology, School of MedicineBackground In the 1970s, numerous medical reports, media coverage, and litigation around the Dalkon Shield intrauterine device led to a perception that all intrauterine devices cause upper genital tract infection and infertility. Objective This study aimed to assess the association between intrauterine device use and time to conception. Study Design The Fertility After Contraceptive Termination Study is a multicenter, prospective cohort study of women stopping their contraceptive method to attempt conception. We recruited participants between 2011 and 2017. Participants were a convenience sample of women recruited from academic centers in Philadelphia, PA; Los Angeles, CA; St. Louis, MO; Indianapolis, IN; Aurora, CO; and Salt Lake City, UT. Women were eligible if they stopped their contraceptive method within the past 120 days before enrollment, were between 18 and 35 years of age, had no history of infertility or sterilization, and had at least 6 months of follow-up. Baseline data included demographic and reproductive characteristics, past contraceptive use, nucleic acid amplification testing for sexually transmitted infections, and serology for past infection with Chlamydia trachomatis, Trichomonas vaginalis, and Mycoplasma genitalium. The primary exposure was intrauterine device use (ever); the primary outcome was time to conception. All participants were observed longitudinally for up to 24 months. We used piecewise exponential proportional hazards models with multiple imputation to provide hazard ratios and their respective 95% confidence intervals. Results Of the 461 participants, mean age was 28.2 years, 178 (38.7%) were Black, 157 (34.1%) were considered as low socioeconomic status, and 275 (59.7%) had a history of intrauterine device use. Without adjusting for any covariates, the median time to conception was shorter for participants who had a history of intrauterine device use (5.1 months) than participants who never used an intrauterine device (7.5 months). After controlling for potential confounders, the association of past intrauterine device use with time to conception was not statistically significant (adjusted hazard ratio, 1.25; 95% confidence interval, 0.99–1.58). In our multivariable model, age, nulligravidity, Black race, low socioeconomic status, and past Mycoplasma genitalium infection were associated with longer times to conception (hazard ratio, 0.76; 95% confidence interval, 0.58–0.99). Conception by 12 months was lower in participants with past Mycoplasma genitalium infection (68% vs 80% without past infection; P=.019). Conclusion We found no impairment of fertility with ever use of an intrauterine device. Serologic evidence of past Mycoplasma genitalium infection was associated with longer times to conception and higher rates of infertility. Mycoplasma genitalium infection is a potential modifiable cause of infertility.Item Medicaid savings from the Contraceptive CHOICE Project: a cost-savings analysis(Elsevier, 2018-12) Madden, Tessa; Barker, Abigail R.; Huntzberry, Kelsey; Secura, Gina M.; Peipert, Jeffrey F.; McBride, Timothy D.; Obstetrics and Gynecology, School of MedicineBackground Forty-five percent of births in the United States are unintended, and the costs of unintended pregnancy and birth are substantial. Clinical and policy interventions that increase access to the most effective reversible contraceptive methods (intrauterine devices and contraceptive implants) have potential to generate significant cost savings. Evidence of cost savings for these interventions is needed. Objective The purpose of this study was to conduct a cost-savings analysis of the Contraceptive CHOICE Project, which provided counseling and no-cost contraception, to demonstrate the value of investment in enhanced contraceptive care to the Missouri Medicaid program. Study Design The Contraceptive CHOICE Project was a prospective cohort study of 9256 reproductive-age women who were enrolled between 2007 and 2011. Study follow-up was completed October 2013. This analysis includes 5061 Contraceptive CHOICE Project participants who were current Missouri Medicaid beneficiaries or were uninsured and reported household incomes <201% of the federal poverty line. We created a simulated comparison group of women who were receiving care through the Missouri Title X program and modeled the contraception and pregnancy outcomes that would have occurred in the absence of the Contraceptive CHOICE Project. Data about contraceptive use for the comparison group (N=5061) were obtained from the Missouri Title X program and adjusted based on age, race, ethnicity, and income. To make an accurate comparison that would account for the difference in the 2 populations, we used our simulation model to estimate total Contraceptive CHOICE Project costs and total comparison group costs. We reported all costs in 2013 dollars to account for inflation. Results Among the Contraceptive CHOICE Project participants who were included, the uptake of intrauterine devices and implants was 76.1% compared with 4.8% among the comparison group. The estimated contraceptive cost for the simulated Contraceptive CHOICE Project group was $4.0 million vs $2.3 million for the comparison group. The estimated numbers of unintended pregnancies and births averted among the simulated Contraceptive CHOICE Project group compared with the comparison group were 927 and 483, respectively, which represented a savings in pregnancy and maternity care of $6.7 million. We estimated that the total cost savings for the state of Missouri attributable to the Contraceptive CHOICE Project was $5.0 million (40.7%) over the project duration. Conclusion A program providing counseling and no-cost contraception yields substantial cost savings because of the increased uptake of highly effective contraception and consequent averted unintended pregnancy and birth.