All women who are referred to secondary care for cervical cerclage will be screened prior to their antenatal appointment by the C-STICH research nurse or PTB clinic nurse in each centre as a potential participant. The obstetrician or gynaecologist who will be providing the woman’s clinical care and performing the procedure will discuss preventative options and establish eligibility based on history and preferences.
For the majority of women, there will be a delay of at least one night before the cerclage procedure is undertaken, allowing adequate time for consideration of participation in the trial. In some circumstances, where a monitoring ultrasound scan shows a shortening cervix without bulging foetal membranes, the cerclage procedure might be performed the same day. In either situation, the indication for the cerclage will be discussed before the trial is introduced.
Consent to participate in C-STICH will be sought by the obstetrician, but the research nurse for the centre may be involved in the consent discussion. Women will be asked to confirm their consent to participate in the C-STICH trial by initialling the appropriate boxes on the consent form and signing the form in the presence of the person taking consent. Multiple copies will be available to ensure a copy is given to the women; one to be kept in the patient notes, one in the local site file and one sent to the C-STICH Trial Office.
The primary outcome of C-STICH is neonatal mortality at up to one month post-delivery. Rather than contact the trial participant to enquire of their child’s mortality, at the end of the trial a list of NHS numbers assigned to the children born to trial participants will be provided to the Health and Social Care Information Centre (HSCIC). The HSCIC will be asked to confirm if a death certificate has been issued against each number, and if so, the date of death. The participant will be made aware of this in the C-STICH Participant Information Sheet and their agreement will be recorded on the consent form.
All women approached should be recorded on the screening log, available in the investigator site file. This information will only be passed to the coordinating centre as an anonymous screening log.