What matters most: impacted fetal head at caesarean birth

Sometimes during a caesarean birth, a baby’s head can become lodged deep in the pelvis and be difficult to deliver. This is known as impacted fetal head. This happens in around 1 in every 10 unplanned caesarean births. When this happens, the medical team may use special techniques to help the baby to be born safely.

All caesarean births carry some risks. When a baby’s head is difficult to deliver, those risks can be higher for both the mother and the baby. We know this can be a very difficult experience, and we want to help make sure that care is as good as it can be for everyone going through it.

Right now, researchers and healthcare teams don’t always measure the same things when they study this type of birth. This makes it hard to compare findings, share learning, and improve care over time.

We want to understand what are the most important outcomes are for mothers and babies who have experienced interventions to manage an impact fetal head at caesarean birth. This will help us decide a final core outcome set.

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Why have I been invited to participate?

You have been invited because you are:

• A woman who has experienced an impacted fetal head at caesarean birth
• A partner of a woman who has experienced an impacted fetal head at caesarean birth

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Do I have to take part?

No, taking part in the research is entirely voluntary.  It is entirely up to you to decide whether or not you want to take part.  You will be given this information sheet prior to completing the survey and you will be given our contact information to ask any questions you might have before you participate.

If you decide to take part, you will be asked to complete a consent form before completing the survey.

You are free to withdraw at any time, without giving a reason. Once you have taken part in the survey, you are free to withdraw your data up until the data analysis begins, after which time it will not be possible to separate your data from that of others due to anonymisation.

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What would taking part involve?

This project consists of one survey in which you will be:

You will be shown groups of different things that can happen to a mother or baby during or after this type of birth. For each group, we will ask:

• Which of these feels most important to measure and keep track of?
• Which feels least important to measure and keep track of?

There are no right or wrong answers. We just want to know what matters most to you.

Your responses will inform the development of a core outcome set for research and clinical practice in this area.

You do not have to answer all of the questions. However, we hope you will answer as many questions as possible, as this will provide the best possible information about your views.

The online survey is expected to take approximately 20 minutes, however you can take as much time filling in the survey as you require.

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Can I take a break part way through answering questions?

Yes of course. You do not have to answer all the questions in one go.

If you would like to take a break, use the 'Next' button to save your answers. When you return use the same browser and device.

Once you have completed each page, please do press the 'next' or 'submit' button so we receive your responses to that point.

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Can I ask for help to complete the questions?

Please do feel free to ask someone to help you navigate Thiscovery or answer the questions, if you would like. This could be a family member or friend, for example.

If you ask for help, please do answer the questions from your own point of view, rather than the views of the person helping.

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Is there a deadline for completing the questions?

The deadline for completing questions is [insert date here]. Please do answer all the questions you wish to by this date.

Before you start

• To take part you need to be over the age of 18 and:
  
  • someone who has had an emergency caesarean birth
  • the partner of someone who has had an emergency caesarean birth
• We will not ask you to describe any of your experiences. You do not have to answer all of the questions if you don’t want to.
• The survey should take around 20 minutes
• If you would like to receive a summary of the results, we will ask you to provide us with your name and email address at the end.
• You do not have to complete the survey all at once but if you do need to take a break, use the same device and browser when you return
• Prize draw: One of five £10 Amazon shopping vouchers. You don't need to finish the survey to enter.

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What are the possible benefits of taking part?

We cannot promise that taking part in the survey will benefit you directly, but the findings will help to determine the final core outcome set. By taking part in this study, you will have an opportunity to share your views on what needs to be measured for women and babies who experience an impacted fetal head during caesarean birth. This is a key step in developing a standardised approach to outcome measurement in this important area. Some people like to know they are contributing to research designed to help others.

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What are the possible disadvantages and risks involved in taking part?

Talking about caesarean birth can be difficult. We won’t ask you to answer any questions about previous experiences you might have had; we are just interested in knowing your views on important outcomes. You do not have to answer any questions you do not want to and can stop at any time. If you find taking part in this project distressing in any way, please get in touch directly with us via help@thiscovery.org.

Helpful organisations for pregnancy and birth related trauma include AIMS (+44 (0) 300 365 0663; helpline@aims.org.uk) and the Birth Trauma Association (support@birthtraumaassociation.org.uk).

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We will need to use information from you for this research project.

This information will include your name and contact details if you have chosen to provide these. People will use this information to do the research or to check your records to make sure that the research is being done properly.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

University of Bristol is the sponsor of this research. University of Bristol is responsible for looking after your information. We will not share your information related to this research project with any other organisations.

We will keep all information about you safe and secure.

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.  

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What are your choices about how your information is used?

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.

You have the right to ask us to access, remove, change or delete data we hold about you for the purposes of the study. You can also object to our processing of your data. We might not always be able to do this if it means we cannot use your data to do the research. If so, we will tell you why we cannot do this

Data collected prior to withdrawal will be included in the study analysis unless a participant specifically requests that their data are removed. Once the data analysis has begun you cannot withdraw your data.

If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.

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How will we use information about you after the study ends?

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.

We will keep your study data for a maximum of 1 year. The study data will then be fully anonymised and securely archived or destroyed.

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What will happen to my data?

Your involvement in the study will remain confidential. This information will only be available to research staff and national bodies which monitor whether research studies are conducted properly. Your study data will be anonymised. This means that it will be given an identification number and any identifying information about you will be removed. Therefore, it will not be possible to identify you by name from any aspect of documentation or reporting for this research study. At the end of the study your data will be made “controlled access”. This mean that any access requests for data will be referred to the study committee for review on a case-by-case basis.

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What is controlled access?

The data set will be stored on the University of Bristol Secure Servers. All members of the core study team will have access to this data. Individuals in the wider steering group will receive parts of the data, as required, for analysis and discussion, and can access the full dataset by visiting the University of Bristol.

It is not envisaged that this data will be used for analysis outside the remit of this study, however, we will ask permission to use the data for subsequent analysis in the consent form.

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What will happen to the results of the research project?

We will publish the results of this study in the form of a report. We will also present the results at conferences focussed on women’s health and childbirth. All the people who are involved in this study will be able to access the results. You will not be identified as a named individual in any report or publication. We can also provide you with feedback about the study. You will be asked if you want to receive the report or summary information video by email at the end of the survey.

Who is organising the research?

This research is being organised by Dr Andrew Demetri, Honorary Research Fellow, who is part of research team at the University of Bristol, comprising clinicians and researchers.

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Who has reviewed the study?

Before any research is carried out it has to be checked by the University of Faculty of Health Sciences Research Ethics Committee and Health Regulation Authority (HRA). They make sure the research is safe and fair.

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Where can you find out more about how your information is used?

You can find out more about how we use your information:

• by visiting the HRA website: www.hra.nhs.uk/patientdataandresearch
• at www.bristol.ac.uk/secretary/data-protection/policy/research-participant-fair-processing-notice/
• by asking one of the research team
• by sending an email to data-protection@bristol.ac.uk, or
• by calling the University’s Data Protection Officer on (0117) 4556325.

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Contact details

If you have any questions about the study and want further information, please contact the study’s principal investigator, Dr Andrew Demetri, andrew.demetri@bristol.ac.uk

If you have any concerns and would like to contact someone who is independent of the study, please contact the University of Bristol Governance Team by email: research-governance@bristol.ac.uk

• As a thank you for taking part, you will be entered into a prize draw to win one of five £10 Amazon shopping vouchers. You do not need to finish the survey to enter.
• We are offering five prizes:
  
  • Five prizes of £10 Amazon shopping vouchers
  • No cash alternative available
• How to enter:
  
  • Provide your name and email at the end of the survey
  • You can enter even if you don’t finish the survey
  • You can also enter by emailing help@thiscovery.org before [X]
  • Only one entry per person
• Important dates:
  
  • Survey closes: [X]
  • Draw takes place: [X]
  • Winners contacted: within 6 weeks of the draw (by [X])
  • Prizes delivered: within 6 weeks of being contacted
• How winners are chosen:
  
  • Winners are selected at random
  • The draw is administered by Thiscovery
• How winners are contacted:
  
  • We’ll email you at the address you provide
  • You’ll have 7 days to respond
  • If you do not respond in time, we’ll select another winner
• Your privacy:
  
  • Thiscovery administers all prizes
  • The University of Bristol does not receive winner names
  • Your prize draw details are deleted 8 weeks after all prizes are delivered
• If you also consent to other uses of your email (like receiving results or learning about future opportunities), those details are kept for different periods as described in the privacy notice.
• Questions about the prize draw? Email help@thiscovery.org