These questions have been asked by UKMidSS reporters and others during the set-up phase of UKMidSS and during the studies we have conducted so far. If you have a question which is not answered here please contact us on email@example.com
Why did UKMidSS previously only include alongside midwifery units (AMUs) and not other midwifery-led settings?
When UKMidSS was set-up we initially aimed to include all AMUs because they account for around 80% of women who start labour care in a midwifery-led setting. As this was successful we are now including freestanding midwifery units (FMUs) too and we hope to be able to expand to include all midwifery-led settings, i.e. home births, in the future.
How do you decide what studies to run using UKMidSS?
The topics for the first four studies were decided upon after consultation with senior midwives, the Royal College of Midwives and maternity care researchers in the NPEU and elsewhere. Suggestions for further studies have been discussed at our Study Days and are considered by the UKMidSS Steering Group. If you have an idea for a study please get in touch.
I’m a UKMidSS Reporter, but I don’t know what I’m supposed to do – can you help?
Yes, thank you for contributing to UKMidSS! As a UKMidSS Reporter you are our main point of contact for UKMidSS in your AMU or FMU. You are also responsible for reporting data to us every month for UKMidSS studies. There is more information in the Guide for UKMidSS Reporters in your white site folder and on the Information for Reporters page on this website. Also on this page our recorded webinars and these are also a good place to start. If you’re having problems, contact us on firstname.lastname@example.org
When does the study start and how long will it last?
The study will start on 1st September 2019 and continue for 12 calendar months, until 31st August 2020. You should start identifying your cases from 1st September and you will receive your first monthly report request email (for your figures for September) on 1st October 2019.
What is a 'case'?
For the PPH Study a 'case' is any woman who gives birth in the midwifery unit and:
who has a PPH requiring transfer to an obstetric unit, where the primary or secondary indication for transfer is PPH (for example, including transfer for retained placenta or perineal trauma where the woman has an associated PPH in the midwifery unit) OR
who receives care from an obstetrician in a midwifery unit for a PPH without transfer to an obstetric unit.
Does a 'case' have to give birth in the midwifery unit? What if they transfer during labour to the obstetric unit?
For this study 'cases' do have to give birth in the midwifery unit. If a woman receives care in the midwifery unit, but is transferred before birth she should not be reported as a case. Any women who deliver on the midwifery unit, irrespective of type of delivery, can be considered as cases if they subsequently have a PPH on the midwifery unit.
What is the definition of PPH? Is it estimated blood loss ?500ml ?
There is no element of estimated blood loss in the definition. The case definition is PPH requiring transfer to obstetric unit or obstetric care. Any woman who has a PPH and is transferred for PPH or who sees an obstetrician for PPH is a case, irrespective of blood loss volume. This also includes women who are transferred for retained placenta or perineal trauma where the woman also has an associated PPH in the midwifery unit.
What figures do I need to report each month?
The number of cases in the midwifery unit in the previous month.
The number of women who gave birth in the midwifery unit in the previous month.
Do we have to identify a ‘control’ for each case for this study?
Yes, for this study we are asking you to select one ‘control’ (or comparison woman) for each ‘case’.
Why are you asking for data about a 'control' as well as the 'case'?
One of the things we want to do in this study is compare the characteristics and care of the 'case', i.e women who have a PPH requiring obstetric care, with other more typical women who gave birth in the midwifery unit and who did not have a PPH (or had a PPH that did not require obstetric intervention).
How do we identify the 'control' – can we just choose any comparison woman?
It's really important that the control is identified carefully and in the same way everywhere. That way we know that our comparison group is representative of women giving birth in midwifery units. For each case, we are asking you to identify one control. To identify the control, make a note of the date and time the case gave birth. Then check your unit birth register or electronic records to find the woman who gave birth in the midwifery unit immediately before the case. That woman is your control for that case.
What happens if the woman giving birth immediately before the case was also a case?
In this instance you should go further back in your register to identify the non-case woman who delivered before each case. For example, if you have two cases one after the other, your controls for these two cases would be the first two non-case women who gave birth in the midwifery unit immediately before the first case.
What happens once I report a case?
In your confirmation email you will see a unique Case ID, beginning PH_ for each case you report. You should record each Case ID in the Case Log in your white UKMidSS folder alongside identifying details for each woman. We then ask you to send us detailed data on the case and one control for each case.
How do I send you data on our cases and controls?
When you report a case, data collection forms for each case and control are created automatically in OpenClinica, our data entry system. When you send us a monthly report you will receive a link to access OpenClinica in your confirmation email.
You will also need a username and password for OpenClinica. If you do not have these, please contact us.
Note: Case IDs and data collection forms are created automatically in OpenClinica when you report a case. You do not ever need to click on the Add New Subject link in OpenClinica.
Once you have access to the woman’s electronic or paper notes you can enter the data in the forms in OpenClinica. We have put sample forms on our website before the start of the study – these are for information only and should not be used to send us data. There is a detailed guide to entering data using OpenClinica in your white UKMidSS folder and on our website: https://www.npeu.ox.ac.uk/ukmidss/reporters.
For the case and control forms, Section 1 contains questions intended to check (a) whether the woman fits the case definition and (b) whether the control has been correctly selected. When entering data in any form, Section 1 should always be completed first.
I've reported a case, but realise that I made a mistake and the woman wasn't a case after all. What should I do?
Please contact us on email@example.com and give us the Case ID of the woman concerned. Please do not 'stop' or change the 'status' of the case in OpenClinica in any way.
Do we have to respond to the monthly reporting emails within a certain period of time?
We don't have a time limit, but you will receive an email every month so it will be easier for you if you don't get too far behind. We will contact you to remind you if we haven't hear from you for a couple of months.
Can we only enter the more detailed data on our cases at the end of the month? It might be harder to track down women's notes once they've gone home.
At the beginning of every month we will ask you to report on your cases for the previous month. As soon as you report a case a unique 'Case ID' and data collection forms will be automatically generated for that woman and you will be able to enter data using OpenClinica. If you wish to identify cases and collect the data you will need from women's notes as you go along you may use our Sample Data Collection Forms to record the data prior to entering it on OpenClinica at a later date.
I've already used OpenClinica to enter data on cases and controls for previous studies (the Previous PPH Study, Severe Obesity Study and Neonatal Admission Study) but I can't see my PPH Study cases - where are they?
To see your PPH Study cases you need to click on the Change Study/Site link at the top of the screen in OpenClinica. You will then be able to switch to see yourPPH cases. To check that you are looking at the correct screen, you should see UKMidSS: PPH Study at the top of the screen and your Case IDs should all begin with PH_.
Do we need any particular software to report to UKMidSS?
Our reporting and data collection systems use email and web browsers, the programme that you use to access the internet. UKMidSS should work with the following browsers, but in every case we recommend updating your browser to the latest possible version:
Internet Explorer (version 11 or later)
Microsoft Edge (all versions)
Firefox (version 47 or later)
Chrome (version 49 or later)
If you use Google Chrome to access OpenClinica you will see a message saying that Firefox and Internet Explorer are recommended. Don’t worry, Google Chrome will work just as well. If you have any problems please email us on firstname.lastname@example.org
I haven’t received my OpenClinica password, or my OpenClinica password doesn’t work. What should I do?