Background and study aims
The aim of this trial is to find out if labour should be started a little earlier for women with babies who appear to be bigger than expected.
We want to find out if doing this could prevent problems for women and babies during birth. This issue has been identified as an important unanswered question for the NHS.
The results of this trial will help women, obstetricians and midwives decide on the best way to deliver bigger babies.
Why are we doing the trial?
In most cases women with big babies have a normal labour and birth. However, there is an increased chance that the birth may be more difficult, which could result in shoulder dystocia.
‘Shoulder dystocia’ is when the baby’s head has been born but one of the shoulders becomes stuck behind the woman’s pubic bone (one of the bones in the pelvis), delaying the birth of the baby’s body.
If this happens, the midwives and doctors will use different ways to help to free the baby’s shoulders, which usually allows the body to be born.
Most babies who experience shoulder dystocia will experience no complications. But in some cases there can be stretching of the nerves in the baby’s neck. This can cause loss of movement in the baby’s arm (Erb’s Palsy). In most cases the loss of movement is temporary, but for some babies this can be permanent.
We currently do not know the best way to deliver bigger babies. It may be that starting labour earlier, when babies are smaller, means that shoulder dystocia is less likely to happen. However, starting labour early may also have risks for women and babies.
The aim of this trial is to answer these important questions.
What will happen if I agree to take part?
If you would like to take part you will meet a member of the research team. They will explain the trial to you and ask you to sign a consent form.
You will be randomly selected to either have your labour induced (started) at around 38 weeks (the intervention group) or to continue as normal (the standard care group).
Once your baby has been born we will collect information from your hospital records about the birth. We will contact you when your baby is two and six months old and ask you questions about your and your baby’s health and well-being.
Even if you do not want to join the trial, you can still take part in the research. This is known as ‘the cohort study’.
Who has reviewed this trial?
To protect patients, this trial was reviewed and approved by South West - Exeter Research Ethics Committee (the REC) on 19 March 2018 [18/SW/0039].
The REC are an independent group of people who review all research carried out in the NHS to protect your safety, rights, well-being and dignity.
What information will you collect?
University Hospitals Coventry and Warwickshire (UHCW) are the sponsor for this trial and will act as the data controller. This means that they are responsible for looking after the information we collect about you and for making sure we are using it properly. The trial sites are the data processors and will be under the instruction of the trial sponsor. You can find out more about how your information is used, how to exercise your rights relating to processing personal information, and the contact details of the data protection officer at https://www.uhcw.nhs.uk/privacy/.
We will collect information from your hospital records about the birth of your baby and about your and your baby’s health during the time you are in hospital. This will include ethnic origin and health information, which is regarded as ‘special category personal data’. To protect your rights, we will use the minimum amount of personally identifiable information possible. We will collect your name, date of birth, address, phone number and email address from your medical records, so we can contact you about the research and make sure that relevant information about the trial is recorded for your care, and to oversee the quality of the research. In order to do this, individuals from the trials sponsor and regulatory authorities may review your medical notes and research records.
We will also use your information to contact you two and six months after your baby is born to ask you to fill in questionnaires about your and your baby’s health and well-being, and about what, if any, healthcare services you and your baby have used. If you tell us that your baby has had important health problems over this time, with your permission, we will collect information about these from your or your baby’s hospital and GP records, or we may contact you to discuss these problems further. When we receive your questionnaire, we will review your information and if we find that any important details are missing we will contact you to collect this.
If you have given permission, we may also contact you and ask if you are willing to take part in a face-to-face interview with a member of our research team about your experiences of taking part in the Big Baby Trial. With your permission, we would also like to interview your partner or birth partner to understand what their experience of taking part in the Big Baby Trial was like.
In the UK, it is very rare that a woman dies during late pregnancy or during or after the birth (this risk is less than one in 10,000). It is also uncommon that a baby dies in the first 28 days after the birth (the risk is less than one in 400). If either of these things happens while you are taking part in this trial, it is important to us that we try to keep any distress to you and your family to a minimum. To help us achieve this, with your permission, we will check your baby’s hospital records before we send the two questionnaires to you (two and six months after the birth) or invite you to take part in an interview or further studies. When we check, your baby’s records, if we find that your baby has died we will contact you through the hospital bereavement service, or an experienced member of the research team will contact you direct by phone. It is important for us to know if you or your baby has died and if so, what caused this. To give us access to this information, we would like your permission to look at linked information held by an organisation called NHS Digital, who look after healthcare information. We would only collect this information if you did not fill in your follow-up questionnaires. We will collect your and your baby’s NHS numbers from your medical records to do this.
Do I have to take part?
It is entirely up to you whether or not you take part in the trial or any other part of the research. You do not have to take part and there will be no difference in any aspects of the care that you receive if you choose not to take part. If you want to take part, you will have an opportunity to discuss this sheet with us, and ask us any questions you may have. We will then ask you to sign a consent form to confirm you have agreed to take part. Even after signing the consent form, if you change your mind you can withdraw from the trial at any time, without having to give a reason. This will not affect the care you receive.
What happens when the research trial stops?
At the end of the trial, which will take 42 months, we will analyse the information we have collected to decide if starting labour early is the best thing to do for women and their babies. In the future, these results will help women who are expecting big babies decide if they should be induced.
Whichever part of the trial you join, we would like to keep the information we hold on you and your baby after the end of the trial. This is so that we can contact you as your baby is growing up (or we can contact your child when he or she has grown up) to find out if anything related to the birth has affected their longer-term health. So that we can do this, we would like your permission to look at Hospital Episode Statistics for you or your child (or both). We will collect your and your baby’s NHS number to do this.
What will happen if I don't want to carry on with the trial?
Taking part in the research trial is entirely voluntary. If you do not want to continue in the trial, you can withdraw at any time without giving a reason and without it affecting your care in any way. If you decide to withdraw from the trial you can choose to have no further contact from us. However, we will keep the information about you that we have already collected if you do this. Your rights to access, change or move your information are limited as we need to manage your information in specific ways in order for the research to be reliable and accurate.
Will information about me and my baby be kept confidential?
Yes. All information we collect about you and your baby is strictly confidential. Once you have agreed to take part in the trial, we will store your contact details in a secure database which the trial team can access. Research information we collect for the trial will refer to you by a unique trial number, so the risk of you being identified is very low. We will hold contact details and research information in separate parts of the database. In rare circumstances a senior researcher from the trial team may need to pass on information we receive during the trial if there is a concern about a significant risk of harm to you or your baby, or to other people. They will only pass information to a person with authority to deal with such concerns and if possible the researcher will explain to you what information they are passing on and why. All information will be stored securely and held at the Perinatal Institute and the Warwick Clinical Trials Unit, in line with all relevant UK laws, and only authorised staff will have access to it.
Who will be able to see my information?
Occasionally we will access your or your baby’s medical records to make sure the information we have collected about you both is accurate. Only authorised staff will do this.
The people who analyse the information will not be able to identify you. We will ask for your permission to tell your GP that you are taking part in the clinical trial. If you do not want us to tell your GP, you will not be able to take part.
Only authorised staff will have access to your personal details and be able to trace your identity. At the end of the study, we will store the information we collect for the trial about you and your baby for at least 25 years if you are in the randomised trial or at least 10 years for the cohort study. This is in line with UK law.
What will happen to the results of this trial?
Once the trial is complete, we will prepare and publish a report. The results will be available to the hospitals that took part in the trial. We may share information relating to the trial in scientific meetings and it may be published in scientific journals. You will not be identified in any reports or publications and none of the information will be able to be traced to you personally. The results of the trial will be published on the Big Baby website.
The UoW privacy statement can be found here: https://warwick.ac.uk/services/idc/dataprotection/privacynotices/researchprivacynotice