Postnatal Instead of Normally-timed Cervical Screening (PINCS)

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2024
INTERVENTION: To understand reasons for non‐participation and establish an up‐take rate, a sub‐study cohort of 100 potential participants will all be approached and the acceptance rate recorded. The reason given by who choose to not participate will be recorded anonymously for those willing to disclose reasons. At appointment 1, potential participants will discuss the study with a member of the research team, and if willing to take part, consent will be obtained and they will complete a 1‐page questionnaire. After delivery, a member of the study team will contact the participant to confirm ongoing willingness to participate and arrange a 6‐week screening appointment. A reminder notification will be conveyed in advance of the appointment. At appointment 2, 6‐weeks after delivery, consent will be confirmed and the participant will perform self‐testing with Coli‐pee sampler. A speculum examination will then be performed and a cervical sample taken using a cervical brush. Samples will be collected in accordance with the NHS CSP guidance by members of the study team who are registered on the Cervical Sample Takers Database. The appointment plan for 12‐week screening will be confirmed, and further appointment made. Following the appointment, the participant will complete a web‐based questionnaire. A reminder notification will be conveyed in advance of the next appointment. Participants will be made aware that the results of the cervical screening test will not be available until after thier 12‐week test is performed. At appointment 3 at 12‐weeks postnatal a Colli‐pee urine sample and cervical sample will be taken with a cervical brush. The participant will be informed of the management process in the case of an abnormal smear result. Following the appointment, the participant will com CONDITION: Cervical screening ; Cancer PRIMARY OUTCOME: 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 OUTCOME: 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); INCLUSION CRITERIA: 1. 24.5 to 64 years 2. Has a uterine cervi Xand 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
Epistemonikos ID: 5b83d6b60b71bbe3e5429a756124f24ab7e5fbba
First added on: Aug 28, 2024