Objective  To evaluate the performance and safety of the Kiwi Omnicup and compare it to conventional vacuum cups in routine clinical practice. Design  A randomised controlled trial of the Kiwi Omnicup versus conventional vacuum cups. Setting  Queen Charlotte's and Chelsea Hospital, a tertiary referral hospital in London from April 2001 to March 2004. Population  Women requiring assisted vaginal delivery by ventouse. Methods  Women were randomised to the Kiwi Omnicup (n = 206) or conventional vacuum cups (n = 198). Data regarding maternal demographics, labour, mode of delivery and maternal and neonatal outcome were collected. Main outcome measures  Failure of delivery with instrument of first choice. Results  The Kiwi Omnicup was less successful at delivery with instrument of first choice than the conventional ventouse, failure rate 30.1 versus 19.2% (RR 1.58; 95% CI 1.10–2.24). It was associated with a greater number of cup detachments (mean 0.68 compared with 0.28, with 44% compared with 18% having at least one detachment [P < 0.0001]). There was no difference in the incidence of severe maternal trauma, and there were no cases of serious neonatal injury. Conclusions  The Kiwi Omnicup is less successful than conventional ventouse in achieving vaginal delivery, but its safety profile is comparable.

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Objective: Changes in health care delivery and policies resulting from translational research efforts are intended to benefit a broad segment of the affected population. Yet, uptake of new approaches may not occur at the same level and/or pace in all groups, inadvertently increasing disparities in cancer outcomes. Our objective is to explore the impact of recently enacted legislation associated with routine mammography screening on Hispanic /Latino women living in Connecticut. Background: Breast densities are the non-fat (epithelial and stromal) breast tissue observable on screening mammograms. They are associated with a 4 to 6 fold increase in breast cancer risk and complicate the reading of screening mammograms, resulting in lowered sensitivity. Connecticut (CT) and many other states have enacted legislation requiring supplemental testing to be offered to women with dense breasts. Per CT statute, insurance companies must cover the cost of ultrasound screening of an entire breast/breasts for women with heterogeneously or extremely dense breasts. Additionally, personal information on breast density must be included in the mailed result following a screening mammogram. The intent is to improve early detection in women with dense breasts and to increase awareness of the greater risk of associated with dense breast tissue. Methods: After this law was enacted in 2008, we undertook a large prospective study of mammography screening in community based Hispanic/Latinas. We enrolled women seeking care in primary health care settings in the 4 CT cities with the largest H/L populations. Eligible women were ages 40-75, self-identified as H/L, and had negative history for breast cancer or breast biopsy. With 75% participation for baseline interview and 98% consent for medical record review, we report baseline interview data and mammography results (medical records) over a 2.5 - 4 year follow-up on 668 H/L women, ages 40-79, living in CT at the time of enrollment (2009-2011). Results: The women in this study were mostly foreign or Puerto Rican born (84%), lower socioeconomic status (51% with household incomes less than $10,000 per year; 54% less had than a high school education) than the general population; median age was 51. Nearly half (46.0%) reported no usual care provider. Only 14% reported speaking English "very well". Most women reported that they received a mammogram in the previous year (65.0%). 21.4% of women met the criteria for receiving additional bilateral ultrasound testing due to heterogeneously dense (19.2%) or extremely dense (2.3%) breast tissue on screening mammograms occurring during follow up. Of the 128 women eligible for follow-up ultrasound, 18 (14%) received this exam. Conclusion: Although state law requires patient notification of breast density and insurance coverage for supplementary bilateral ultrasound tests in women with moderate to extremely dense breasts, our results show low uptake in Hispanic/Latino women in CT. In this largely foreign born, English second language population, effective communication regarding breast cancer risk, breast density, and the availability of follow-up ultrasound or other testing may represent a significant cancer care challenge. Citation Format: Jones BA, Philpotts L, Cooley R, Silber A, Epstein L, Claye E. Impact of breast density legislation on Hispanic / Latinas in the Northeast, US. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr PD4-07.

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Introduction: Breast densities are the non-fat (epithelial and stromal) breast tissue observable on screening mammograms. Known to be associated with a 4 to 6 fold increase in breast cancer risk, dense breast patterns complicate the reading of screening mammograms resulting in lowered sensitivity. Little is currently known about the prevalence and/or predictors of breast density in Hispanic/Latino women living in the Northeast, US. Objective: The goal of this prospective study is to identify risk factors for high risk breast density patterns among a large cohort of Hispanic/Latino women with ancestral ties primarily to the Eastern Caribbean (Puerto Rico and the Dominican Republic) as well as Central and South America. Because the hormonal milieu is somewhat different in Hispanic/Latinas compared with White women, and likely also differs from that of Hispanic/Latinas living in other parts of the US, we explored the role of reproductive and physiological factors in high risk breast density patterns. Methods: We analyzed breast density predictors in an established cohort of 1,600 Hispanic/Latino women recruited from primary care clinics in 4 cities with the largest enclaves of Hispanic/Latinos in Connecticut. Hour-long telephone interviews provided baseline data on biological, medical care, and sociodemographic factors. We retrieved radiology records on 1570 (98.7%) consenting women. For this analysis, we report predictors of breast density among the 1,040 (65.4%) women who received at least one screening mammogram during 2 to 4 years of follow-up. Breast density classification was based on radiologist assigned BI-RADS classification. Associations between predictors and high risk breast density patterns were examined using chi square tests. Multivariate analyses were conducted using logistic regression; odds ratios (OR) and 95% confidence intervals (CI) are reported. Results: Of the 1,040 women who received at least one screening mammogram during the follow-up period, 280 (27%) women were identified as having high risk dense breasts (extremely or heterogeneously dense, i.e., greater than 50% of the breast composed of fibroglandular densities), while 760 women (73%) were classified as having nondense breasts (fatty or scattered fibroglandular densities), suggesting a lower prevalence of high risk breast density patterns in this population. In multivariate analysis, breast density predictors were similar to those reported for the general population (mostly White) women, and are similar to known risk factors for breast cancer. However, we found that Hispanic/Latinas with diabetes to be at significantly reduced odds of high risk breast density patterns. There was also evidence that the relationship between age at menarche and density was modified by BMI, with early age at menarche a risk factor among normal and underweight women only. Conclusion: Our findings suggest that Hispanic/Latino women may differ in breast density prevalence relative to the general population. However, we observed a protective effect of diabetes and a potential interaction between age at menarche and BMI. This investigation enhances our understanding of breast density in a subset of the Hispanic/Latino population and provides the basis for further research. Citation Format: Jones BA, Claye E, Philpotts L, Hooley R, Silber A, Epstein L. Risk Factors for high risk breast density patterns in Hispanic/Latinas living in the Northeast, US [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P2-13-02.