Cervical screening Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. 24.5 to 64 years 2. Has a uterine cervix and eligible for cervical screening 3. Currently pregnant or recently delivered 4. <6 weeks postpartum 5. Valid informed consent to cervical screening at 6 and 12 weeks postnatal
Exclusion criteria
Exclusion criteria: 1. <24.5 years old 2. Absence of uterine cervix or ineligible for cervical screening 3. Lack of valid informed consent to screening at 6 weeks postnatal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the acceptability and feasibility of a paired study design 1. Acceptability: 1.1. Recruitment and completion rates of undergoing testing at 6 and 12 weeks in the study. 1.2. Acceptability will be measured via a patient-reported outcomes questionnaire following testing at 6 and 12 weeks postnatal, including a 10-point visual analogue pain scale 2. Feasibility: How many women need to be approached for one to consent? Measured using study records | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluate acceptability of clinician-taken cervical samples and urine self-screening tests in those who decline, in those who consent both at 6 and 12 weeks using questionnaire data (measured in a 100-patient sub-study of all of those approached about the study) 2. Assess the quality of cervical samples from clinician-taken samples at 6-weeks postnatal against standard NHS Cervical Screening Programme criteria 3. To determine the agreement in HR HPV status at 6- and 12-weeks postnatal between clinician-taken cervical samples and self-testing using urine tests (using a 2-by-2 table to test for sensitivity, specificity, negative and postitive predictive values) | — |
Countries
England, United Kingdom