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Background-In the female genital tract, vaginal colposcopy, endometrial mucosal integrity and inflammatory mediators are potential in vivo biomarkers of microbicide and contraceptive safety.Study Design-A randomized, blinded crossover trial of 18 subjects comparing effects of Gynol II (putative inflammatory gel), HEC (putative inert gel) and no gel exposure on endometrial and vaginal epithelial integrity and endometrial and vaginal inflammatory markers (IL-1β, IL-6, IL-8, MCP-1, MIP-1α, MIP-1β, RANTES, TNF-α, IL-1RA, IL-10, SLPI).Results-Gynol II was associated with more vaginal lesions. No endometrial disruptions were observed across conditions. In the vagina, RANTES (p=0.055) and IL-6 (p=0.04) were higher after HEC exposure than at baseline. In the endometrium, IL-1β (p=0.003) and were lower after Gynol II cycles than after no gel.Conclusions-Gynol II and HEC may modulate inflammatory markers in the vagina and endometrium. How these changes relate to infection susceptibility warrants further study.

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Objective: To evaluate accuracy of ultrasound for symptomatic first trimester pregnancies based on presenting signs and symptoms. Methods: Ultrasound diagnosis at first presentation was compared with ultimate clinical diagnosis for 1880 pregnant women who presented with complaints of vaginal bleeding and/or abdominal pain. Sensitivity, specificity, positive (PPV) and negative predictive values (NPV) and overall diagnostic accuracy of initial ultrasound impression were calculated and stratified by initial serum hCG levels, pain and bleeding. Results: At initial presentation 739 (39%) received a diagnostic ultrasound. A definitive ultrasound diagnosis of ectopic pregnancy (EP) at presentation resulted in low sensitivity, but excellent specificity and a high PPV. When the ultrasound diagnosis was suspicious but not definitive for EP, sensitivity increased (p < 0.0001) but PPV decreased (p = 0.005) Sensitivity (p < 0.0001) and PPV (p = 0.02) of initial ultrasound for EP was higher with a higher serum hCG level. Test characteristics of initial ultrasound were not substantially altered when stratified by the presence or absence of pain; ultrasound was less accurate when bleeding was the chief complaint (p = 0.0001). Conclusion:The accuracy of an initial ultrasound evaluation in detecting EP is highest with a high hCG. Care must also be taken in the interpretation of ultrasound when the findings are not definitive, or when a patient has bleeding. The presence of pain did not significantly alter the accuracy of ultrasound. Support: NIH Grant R01-HD036455 OP35.04Prediction of location of a nonviable pregnancy when ultrasound is nondiagnostic