OBJECTIVE: To compare, in pregnant women, the endocervical cell yield of the Cytobrush Cell Collector and the Cervex-Brush Cell Sampler with the standard cotton swab, and to determine the incidence of serious adverse events associated with the collection techniques. METHODS: In a randomized, controlled clinical trial, 352 pregnant women undergoing initial obstetric evaluation were randomly assigned to either the cotton swab and modified Ayers spatula, Cytobrush and modified Ayers spatula, or Cervex-Brush. The cytopathology laboratory, blinded to the Papanicolaou smear method, screened the smears using the Bethesda System guidelines. Statistical analyses were performed using the Pearson chi 2 and analysis of variance tests. RESULTS: There was an increased detection of endocervical cells in pregnant patients with both the Cytobrush and modified Ayers spatula (90.7%) and the Cervex-Brush (83.3%) methods, compared with the cotton swab and modified Ayers spatula (70.8%) (P = .0001 and P = .0233, respectively). There was no statistically significant difference between the Cytobrush-spatula and Cervex-Brush groups (P = .0956). Although there were more bloody Papanicolaou smears in the study groups, this was neither clinically nor statistically significant because all the samples were interpretable and repeat samples due to bloody specimens were not required. There were no serious adverse events associated with the study group methods. CONCLUSION: Performance of Papanicolaou smears using the Cytobrush and modified Ayers spatula and with the Cervex-Brush improved Papanicolaou smear adequacy as compared with the cotton swab and modified Ayers spatula. Despite an increased incidence of spotting following collection, these techniques were not associated with an increase in serious adverse events. Based on the cost per item and a clinically significant increase in endocervical cell yield, we recommend the Cytobrush and modified Ayers spatula for cytologic screening in pregnant women.
RCT Entities:
OBJECTIVE: To compare, in pregnant women, the endocervical cell yield of the Cytobrush Cell Collector and the Cervex-Brush Cell Sampler with the standard cotton swab, and to determine the incidence of serious adverse events associated with the collection techniques. METHODS: In a randomized, controlled clinical trial, 352 pregnant women undergoing initial obstetric evaluation were randomly assigned to either the cotton swab and modified Ayers spatula, Cytobrush and modified Ayers spatula, or Cervex-Brush. The cytopathology laboratory, blinded to the Papanicolaou smear method, screened the smears using the Bethesda System guidelines. Statistical analyses were performed using the Pearson chi 2 and analysis of variance tests. RESULTS: There was an increased detection of endocervical cells in pregnant patients with both the Cytobrush and modified Ayers spatula (90.7%) and the Cervex-Brush (83.3%) methods, compared with the cotton swab and modified Ayers spatula (70.8%) (P = .0001 and P = .0233, respectively). There was no statistically significant difference between the Cytobrush-spatula and Cervex-Brush groups (P = .0956). Although there were more bloody Papanicolaou smears in the study groups, this was neither clinically nor statistically significant because all the samples were interpretable and repeat samples due to bloody specimens were not required. There were no serious adverse events associated with the study group methods. CONCLUSION: Performance of Papanicolaou smears using the Cytobrush and modified Ayers spatula and with the Cervex-Brush improved Papanicolaou smear adequacy as compared with the cotton swab and modified Ayers spatula. Despite an increased incidence of spotting following collection, these techniques were not associated with an increase in serious adverse events. Based on the cost per item and a clinically significant increase in endocervical cell yield, we recommend the Cytobrush and modified Ayers spatula for cytologic screening in pregnant women.
Authors: Alan D Bolnick; Rani Fritz; Chandni Jain; Leena Kadam; Jay M Bolnick; Brian A Kilburn; Manvinder Singh; Michael P Diamond; Sascha Drewlo; D Randall Armant Journal: Reprod Sci Date: 2016-02-25 Impact factor: 3.060
Authors: Chandni V Jain; Leena Kadam; Marie van Dijk; Hamid-Reza Kohan-Ghadr; Brian A Kilburn; Craig Hartman; Vicki Mazzorana; Allerdien Visser; Michael Hertz; Alan D Bolnick; Rani Fritz; D Randall Armant; Sascha Drewlo Journal: Sci Transl Med Date: 2016-11-02 Impact factor: 19.319
Authors: Jay M Bolnick; Hamid-Reza Kohan-Ghadr; Rani Fritz; Alan D Bolnick; Brian A Kilburn; Michael P Diamond; D Randall Armant; Sascha Drewlo Journal: Sci Rep Date: 2016-09-23 Impact factor: 4.379