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A Single-Arm Comparison Study with Cervical Cytology to Evaluate the Efficacy of HPV Screening in Pregnant Women

A Single-Arm Comparison Study with Cervical Cytology to Evaluate the Efficacy of HPV Screening in Pregnant Women

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030240280
Enrollment
5000
Registered
2024-08-20
Start date
2024-10-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer pregnant woman, cervical cancer, HPV screening, cytology screening

Interventions

Cervical abrasion and colposcopy
cervical abrasion, colposcopy

Sponsors

Mizushima Taichi
Lead Sponsor
Miyagi Etsuko
Collaborator

Eligibility

Sex/Gender
Female

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

MeasureTime 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

MeasureTime 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

Public ContactTaichi Mizushima

Yokohama City University Hospital

tmizushi@yokohama-cu.ac.jp+81-45-787-2800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026