Methods
We performed a retrospective cohort study of all women delivered at our center in 2013 with cervical cytology within three years prior to delivery. Patients were excluded if they had a history of any procedures for cervical dysplasia, excluding biopsy. Individual patient medical record review was undertaken. Patients were presumed to be HPV positive with high or low-grade lesions on pap or HPV positive; patients were considered HPV negative with normal or atypical cells on pap with negative HPV on co-testing. The primary outcome was the rate of PTB (<37 weeks). Secondary outcomes included birth <34 weeks, spontaneous PTB, preterm premature rupture of membranes (PROM), and a perinatal morbidity composite. Multivariable logistic regression was performed to adjust for confounders, including demographic variables, diabetes, prior PTB, chronic hypertension and other genital infections. Assuming a 10% prevalence of HPV, a PTB rate of 16%, alpha of 0.05, and beta of 0.1, we needed 1963 patients to detect a 50% difference in the preterm birth rate.
Methods
We performed a retrospective cohort study of all women delivered at our center in 2013 with cervical cytology within three years prior to delivery. Patients were excluded if they had a history of any procedures for cervical dysplasia, excluding biopsy. Individual patient medical record review was undertaken. Patients were presumed to be HPV positive with high or low-grade lesions on pap or HPV positive; patients were considered HPV negative with normal or atypical cells on pap with negative HPV on co-testing. The primary outcome was the rate of PTB (<37 weeks). Secondary outcomes included birth <34 weeks, spontaneous PTB, preterm premature rupture of membranes (PROM), and a perinatal morbidity composite. Multivariable logistic regression was performed to adjust for confounders, including demographic variables, diabetes, prior PTB, chronic hypertension and other genital infections. Assuming a 10% prevalence of HPV, a PTB rate of 16%, alpha of 0.05, and beta of 0.1, we needed 1963 patients to detect a 50% difference in the preterm birth rate.
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