cervical cancer pregnant woman, cervical cancer, HPV screening, cytology screening
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) 30 years of age or older 2) Less than 17 weeks pregnant
Exclusion criteria
Exclusion criteria: 1) No cervix 2) Undergoing treatment or history of invasive cancer of the cervix 3) Undergoing treatment or follow-up at a medical institution for precancerous lesion of the cervix or suspected precancerous lesion of the cervix 4) Other cases in which the subject is judged to be inappropriate by the physician's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test the non-inferiority of HPV screening to cytology screening for the detection rate of CIN2+ immediately after early pregnancy testing using a mathematical statistical model. | — |
Secondary
| Measure | Time frame |
|---|---|
| Descriptive statistics (background of target population), comparison of lesion detection rates between cytology and HPV screening, comparison by age group, comparison of risk of lesion progression by HPV subtype, HPV positivity rate at 1 year, comparison between testing methods, comparison of risk of lesion progression in cytology positive cases, rate of definitive results for testing methods, prognosis for each group classified as early pregnancy Assessment of adverse reactions | — |
Contacts
Yokohama City University Hospital