DO WE NEED TO BE USING THE BADGERNET ELECTRONIC MATERNITY RECORDS TO TAKE PART?
Yes. At the moment we are only recruiting sites that use the BadgerNet electronic maternity records. This is because we have an agreement in place with Clevermed Ltd (developer of BadgerNet platform) which facilitates extraction of de-identified data from participating sites.
MY SITE DOES NOT OFFER CERVICAL RIPENING. CAN WE STILL TAKE PART?
Yes. If you are using BadgerNet electronic maternity records you can take part regardless of the method and setting of cervical ripening offered within your unit.
WILL WE GET ACCRUAL FOR OUR PATIENT DATA INCLUDED IN THE STUDY?
Yes. Accrual will be allocated centrally by the study team for de-identified patient record extracted from your site. You will also get accrual for each patient completing the online survey (allocation based on postcode given at time of completion of survey).
HOW LONG WILL THE STUDY LAST?
We will be collecting data for 20 months in total. The expected end date is November 2022.
WILL WE GET FEEDBACK ON THE QUALITY OF OUR DATA?
Yes. De-identified will not be checked at the individual patient data level, but aggregate data by site is routinely reviewed by the study statistician to look for outliers, common errors and key missing data. If there are any data issues identified with the data from your site the study midwife will work with the local CHOICE Champion to help resolve these.
IS THE DATA WE SEND TO YOU SECURE?
Yes. Only de-identified data is sent from site to the study researchers based at the University of Edinburgh. All de-identified data is encrypted before secure transfer to the study researchers, and access to this de-identified data is restricted to the study team only.
What happens if a women is booked for IOL CHOICE site but ends up giving birth at a CHOICE site (or vice versa)?
The Data extract will only take data from sites that are consented for CHOICE. It will look at Care location at Booking and Care location at Birth if both of these are CHOICE sites the data will be extracted.
Can we take part if we do not offer OP IOL ?
Can we stay in the study take part if our IOL practice changes after SIV?
Yes, but please let us know if your local practices change
Can we take part if we don’t use BadgerNet maternity?
No, at the moment we are only recruiting sites that use the BadgerNet maternity records system. This may change in the future and so you can register your interest at CHOICE.Study@ed.ac.uk if you would like to be kept informed about changes to site feasibility.
Are women randomised to OP IOL/hospital IOL?
No, this is an observational cohort study and we are collecting clinical data collected as part of routine care.
Can women access the online survey outwith the BadgerNet maternity portal?
No, eligibility is determined through the BadgerNet and only eligible women are invited to participate by way of URL for the online survey
Is the postnatal survey only for women at the five qCHOICE sites?
No, women at all CHOICE Study sites that use Push Notifications sites will be invited to complete a survey.
How do women provide informed consent for qCHOICE survey and interviews?
The survey uses an online consent process, and CHOICE Study researchers will gain informed consent from women and birth partners who agree to interview.
What information is available about the CHOICE Study?
We have a range of information available: posters for clinical areas, participant informations sheets and Study leaflets. Women and staff can also the study materials section.
How do women access information about the CHOICE Study?
The participant information sheet can be found in the recommended reading section of Badgernet maternity notes from booking, and will be signposted to women after an induction is booked.
Is the CHOICE Study information only available in English?
No, our study leaflets and poster are also available in: Tamil, Urdu, Polish, Bulgarian and Romanian
How do women opt out of the CHOICE Study?
Women who opt out of secondary data use will not be included in CHOICE. Additionally, women can tell their obstetrician or midwife or the local CHOICE Champion and they can then record that on the Badgernet maternity record.
Do I need to inform women about the postnatal survey?
No, women will receive Push notifications about the survey. However, it would be helpful if you are able to mention the survey to women who are having an induction of labour.
Which women are eligible to complete the postnatal survey?
Any woman who has had a successful induction of labour at or after 39 weeks gestation, and her baby is alive and well, is eligible to take part in the postnatal survey and may be invited to interview.
We are one of the five qCHOICE sites, how many interviews will there be?
We aim to conduct ten staff interviews, three focus groups and record five induction of labour consultations at each participating site. We will work with the Choice Champion and/or local research midwives to arrange these.
Why did we decide on the primary outcome as admission to a neonatal unit (NNU) within 48 hours of birth for 48 hours or more?
NNU admission was chosen as it is a marker of neonatal morbidity, it is the number one core outcome defined for studies of IOL (with stakeholder involvement), admission of a term baby to a NNU separates mother and babies and interrupts the normal bonding process, and it is expensive and is associated with increased postnatal stay for mothers (offsetting any potential gains from a reduced antenatal inpatient stay).
We have restricted it to within 48 hours of birth to ensure it reflects NNU that is likely to be associated with IOL, as opposed to postnatal causes.
Still have questions? Get in touch with the study team: CHOICE.Study@ed.ac.uk and follow us on Twitter @_CHOICEstudy