Cullimore Victoria, Newhouse Rebecca, Baker-Rand Holly, Brentnall Adam R, Chu Kim, Denton Karin, McWilliams Lorna, Sargent Alex, Sundar Sudha, Crosbie Emma J, Morrison Jo
Department of Gynaecological Oncology, Somerset NHS Foundation Trust, Taunton, UK.
Faculty of Health and Life Sciences, University of Exeter, Exeter, UK.
BMJ Open. 2025 May 30;15(5):e092701. doi: 10.1136/bmjopen-2024-092701.
Cervical screening rates in the UK are falling, limiting our ability to prevent cervical cancer. Peak incidence of cervical cancer coincides with average age of childbirth, and women with young children are less likely to be screened. Current UK guidelines advise waiting 12 weeks after delivery to perform cervical screening, but this recommendation is not based on evidence from the era of liquid-based cytology or high-risk human papillomavirus (HPV) testing. New mums suggested offering cervical screening at 6 weeks postdelivery, in conjunction with the postnatal check-up with the general practice team in primary care. This study aims to assess the feasibility and acceptability of a paired-sample study design for cervical screening at 6 weeks and 12 weeks postnatal.
A study of 100 participants will be performed to assess feasibility and acceptability of cervical screening at both 6 weeks and 12 weeks postnatal, with urine self-sampling using a Colli-pee collection device at each time point. This will inform whether women are prepared to undergo cervical screening at 6 weeks postnatal and the feasibility of a future pair-wise diagnostic test accuracy (of HPV and abnormal cervical cytology) study or whether alternative study designs are needed. Participants must be aged 24.5-64 years old and eligible for the National Health Service Cervical Screening Programme (NHS CSP). At each appointment, participants will complete a questionnaire about their experience and thoughts regarding screening. Substudies ask participants who withdraw or decline to participate their reasons, to identify barriers. The study will be closed for recruitment once 100 participants have completed the 6-week screen in Postnatal Instead of Normally-Timed Cervical Screening (PINCS-1) or if recruitment is poor and 50% not recruited by 6 months, indicating that a paired-sample design is not feasible.
Ethical approval for PINCS-1 was given by the Stanmore Research Ethics Committee. The results, including participant feedback at each stage, built into the trial design, will inform the design of large studies to determine accuracy and clinical impact of cervical screening at 6 weeks postnatal, identifying whether giving choice (eg, from timing of appointments and/or offering self-sampling) will improve screening uptake. Data will inform the sample size needed for future studies to have adequate power. Results will also inform future NHS CSP management. Results will be shared via scientific publication and via conventional and social media channels accessed by young women.
ISRCTN10071810.
英国宫颈癌筛查率正在下降，这限制了我们预防宫颈癌的能力。宫颈癌的发病高峰与平均生育年龄相符，有年幼子女的女性接受筛查的可能性较小。英国现行指南建议在分娩后12周进行宫颈癌筛查，但这一建议并非基于液基细胞学或高危型人乳头瘤病毒（HPV）检测时代的证据。新手妈妈们建议在产后6周进行宫颈癌筛查，并与初级保健机构的全科医疗团队进行的产后检查相结合。本研究旨在评估产后6周和12周进行宫颈癌筛查的配对样本研究设计的可行性和可接受性。
将对100名参与者进行研究，以评估产后6周和12周进行宫颈癌筛查的可行性和可接受性，在每个时间点使用Colli-pee收集装置进行尿液自我采样。这将为女性是否准备好在产后6周接受宫颈癌筛查以及未来进行配对诊断试验准确性（HPV和宫颈细胞学异常）研究的可行性提供信息，或者是否需要其他研究设计。参与者必须年龄在24.5至64岁之间，并有资格参加英国国家医疗服务体系宫颈癌筛查计划（NHS CSP）。在每次预约时，参与者将填写一份关于他们对筛查的体验和想法的问卷。子研究询问退出或拒绝参与的参与者原因，以确定障碍。一旦100名参与者完成了产后替代常规宫颈癌筛查（PINCS-1）中的6周筛查，或者如果招募情况不佳且6个月内50%的参与者未被招募，表明配对样本设计不可行，研究将停止招募。
PINCS-1获得了斯坦莫尔研究伦理委员会的伦理批准。研究结果，包括纳入试验设计的每个阶段的参与者反馈，将为大型研究的设计提供信息，以确定产后6周宫颈癌筛查的准确性和临床影响，确定给予选择（例如，预约时间和/或提供自我采样）是否会提高筛查参与率。数据将为未来研究所需的样本量提供信息，以确保有足够的效力。研究结果还将为未来NHS CSP的管理提供信息。研究结果将通过科学出版物以及年轻女性可访问的传统媒体和社交媒体渠道分享。
ISRCTN10071810
