Investigating the acceptability and accuracy of cervical screening and self-sampling in postnatal women to coincide with the 6-week postnatal check-up
Lead Research Organisation:
Taunton & Somerset NHS Foundation Trust
Department Name: Taunton and Somerset Hospital
Abstract
The NHS Cervical Screening Programme (NHS CSP) has been hugely successful since introduction in 1998 in the UK. However, in 2018, screening rates were at a historical low, with screening rates down to 50% in some areas, especially in younger women & new mums, despite cervical cancer peak incidence occurring in this 25-35 year age group.
The peak incidence of cervical cancer coincides with the time when women are having children. During pregnancy and the postnatal period, women have multiple interactions with healthcare professionals and discussions regarding screening for a range of conditions. Pregnancy provides an ideal opportunity to inform, educate and facilitate the uptake of cervical screening. In a previous quality improvement study, we improved the screening uptake rate in our local postnatal population by 8% with educational packages aimed at pregnant women and midwives. As part of this work we conducted a number of focus groups, seeking ideas from key stakeholders. One idea, generated by new mums, young women with cervical cancer, GPs and practice nurses, was that cervical screening should be performed at the 6-week postnatal check up. This check up is well-attended by women, & means that they do not have to find time a few weeks later to prioritise their own healthcare in a separate appointment. Finding time to attend appointments was a key limiting factor identified by new mums & women with cervical cancer. Another factor was a reluctance to have a vaginal examination, which urine self-testing might improve.
Currently postnatal screening is performed after 12-weeks postnatal. This is on the basis of one study of conventional cervical screening ('Pap' smear), when cells from wooden slides were spread directly onto glass slides by the smear-taker. However, we now use liquid-based cytology (LBC), where cells collected on the cervical screening brush are transferred into a pot of special collection liquid, before being transferred to a slide in the lab, using specialist equipment. These LBC samples are much clearer and easier to examine under a microscope. This means that blood from periods or postnatal bleeding/discharge, called lochia, is less of a problem compared to old-style 'Pap' smears. We have also recently changed to primarily testing for high risk Human Papilloma Virus (HR HPV) on this LBC sample, with cytology only performed for those with HR HPV detected. However, despite the lack of evidence to support the current cervical screening schedule, this 12-week time-point remains, until we have data to support a change to combining cervical screening with the 6-week postnatal check up appointment.
We will ask several questions, to help design the best future, much larger study that will be needed to confirm that a 6-week check is safe and improves screening uptake.
1. What are pregnant women and new mums' views on screening at the 6-week postnatal check?
2. What are pregnant women and new mums' views on self-testing at the 6-week postnatal check?
3. Will women attend for a 6-week cervical screening test in a feasibility study and, if they do, would they be willing to have a repeat test at 12-weeks to allow direct comparison?
4. Will it be feasible to randomise women individually to either 6- or 12-weeks tests, or would we need to design future studies differently, e.g by randomising screening times by GP practice or regionally?
5. How well does self-testing with urine samples compare with LBC samples in postnatal women?
We hope these data will inform how to plan a larger study to test the effect of changing to 6-week postnatal testing within the NHS Cervical Screening Programme on the accuracy of testing and ability to prevent cervical cancer, and see whether this improves cervical screening rates in postnatal women.
The peak incidence of cervical cancer coincides with the time when women are having children. During pregnancy and the postnatal period, women have multiple interactions with healthcare professionals and discussions regarding screening for a range of conditions. Pregnancy provides an ideal opportunity to inform, educate and facilitate the uptake of cervical screening. In a previous quality improvement study, we improved the screening uptake rate in our local postnatal population by 8% with educational packages aimed at pregnant women and midwives. As part of this work we conducted a number of focus groups, seeking ideas from key stakeholders. One idea, generated by new mums, young women with cervical cancer, GPs and practice nurses, was that cervical screening should be performed at the 6-week postnatal check up. This check up is well-attended by women, & means that they do not have to find time a few weeks later to prioritise their own healthcare in a separate appointment. Finding time to attend appointments was a key limiting factor identified by new mums & women with cervical cancer. Another factor was a reluctance to have a vaginal examination, which urine self-testing might improve.
Currently postnatal screening is performed after 12-weeks postnatal. This is on the basis of one study of conventional cervical screening ('Pap' smear), when cells from wooden slides were spread directly onto glass slides by the smear-taker. However, we now use liquid-based cytology (LBC), where cells collected on the cervical screening brush are transferred into a pot of special collection liquid, before being transferred to a slide in the lab, using specialist equipment. These LBC samples are much clearer and easier to examine under a microscope. This means that blood from periods or postnatal bleeding/discharge, called lochia, is less of a problem compared to old-style 'Pap' smears. We have also recently changed to primarily testing for high risk Human Papilloma Virus (HR HPV) on this LBC sample, with cytology only performed for those with HR HPV detected. However, despite the lack of evidence to support the current cervical screening schedule, this 12-week time-point remains, until we have data to support a change to combining cervical screening with the 6-week postnatal check up appointment.
We will ask several questions, to help design the best future, much larger study that will be needed to confirm that a 6-week check is safe and improves screening uptake.
1. What are pregnant women and new mums' views on screening at the 6-week postnatal check?
2. What are pregnant women and new mums' views on self-testing at the 6-week postnatal check?
3. Will women attend for a 6-week cervical screening test in a feasibility study and, if they do, would they be willing to have a repeat test at 12-weeks to allow direct comparison?
4. Will it be feasible to randomise women individually to either 6- or 12-weeks tests, or would we need to design future studies differently, e.g by randomising screening times by GP practice or regionally?
5. How well does self-testing with urine samples compare with LBC samples in postnatal women?
We hope these data will inform how to plan a larger study to test the effect of changing to 6-week postnatal testing within the NHS Cervical Screening Programme on the accuracy of testing and ability to prevent cervical cancer, and see whether this improves cervical screening rates in postnatal women.
Technical Summary
By 2019, cervical screening coverage rates in England can be as low as 50%, especially in women under 35 years; those in same-sex relationships; and those who were less well-educated or in lower socio-economic groups. The peak incidence of cervical cancer in 2016 was in the 25 to 30-year age group, which coincides with the average age of a first-time mother in England and Wales (29 years). During pregnancy and the postnatal period women have multiple interactions with healthcare professionals offering opportunities to inform, educate and facilitate the uptake of cervical screening. In a recent quality improvement project, we demonstrated how education of pregnant women and midwives improved cervical screening uptake by 8%. Stakeholder groups of new mums & general practice nurses indicated that combining cervical screening with the 6-wk postnatal check would improve uptake. Current NHS Cervical Screening Programme (NHS CSP) guidelines mandate a delay to >12 wks after delivery, based on results of 1 study using conventional cytology, which pre-dates HPV testing & liquid-based cytology; there are no data to support current practice.
We will examine attitudes of pregnant and postnatal women about timing of cervical screening & attitudes to self-testing using a quantitative & qualitative data. We will perform 2 separate feasibility studies comparing 6- and 12-week testing & self-test urine samples at 6-wks postnatal in a total of 200 women, to inform the design of a future large study to test the accuracy of 6 versus 12 week testing and whether 6-week postnatal testing effects clinical outcomes and screening uptake rates.
Due to increased prevalence of HPV vaccination, it is imperative to perform this study as soon as possible, before HPV-positive rates decline in this cohort and the number needed to test this hypothesis rise to a point where this study requires extremely high numbers.
We will examine attitudes of pregnant and postnatal women about timing of cervical screening & attitudes to self-testing using a quantitative & qualitative data. We will perform 2 separate feasibility studies comparing 6- and 12-week testing & self-test urine samples at 6-wks postnatal in a total of 200 women, to inform the design of a future large study to test the accuracy of 6 versus 12 week testing and whether 6-week postnatal testing effects clinical outcomes and screening uptake rates.
Due to increased prevalence of HPV vaccination, it is imperative to perform this study as soon as possible, before HPV-positive rates decline in this cohort and the number needed to test this hypothesis rise to a point where this study requires extremely high numbers.
