A Randomised Placebo-Controlled Trial of Antenatal Corticosteroids for Planned Birth in Twins: STOPPIT-3

This trial will try to find out if giving a drug called steroids to people expecting twins will help the babies breathe more easily after they are born.

Chief Investigators:
Prof Sarah Stock, University of Edinburgh [email protected]
Dr Sarah Murray, University of Edinburgh [email protected]

Lay summary

People expecting twins may have more problems than people expecting only one baby. Twins may be born earlier than expected.  They might have to go to a special unit called NICU (Neonatal Intensive Care Unit) after they are born, to help with their breathing. If this happens then this means the parents and babies are separated at a special time.

If a parent gets steroids when they are pregnant then this may help the babies’ lungs and make it easier for the babies to breathe when they are born. The babies may not need to go to NICU or, if they do have to go, then it won’t be for as long.

We don’t really know if steroids work for twins and we need to do more research about this. Steroids may help with breathing, or they may possibly affect things such as the babies’ growth and brain development.  There are no guidelines about giving steroids to people who are pregnant with twins and so each hospital has different rules about giving the drug. It would be very good if our research could show if steroids are helpful, or not.

Once the babies are born, we will see how they are developing. In STOPPIT-3 we will ask the parents to tell us about their children when they are 2 years old. This is a good time to get an indication of any long-term positive effects of ACS on babies’ health. After that, we will follow the children until they are 5 years old and will do this by looking at health records and school records.

We will ask at least 50 NHS hospitals in the UK to take part in this trial. At the hospital clinics, we will ask people who are pregnant with twins if they will take part. These people must be 35 weeks pregnant (or more) and having a planned birth (induction of labour/planned caesarean section). People in the trial will get either steroids or a placebo (dummy drug). Neither the doctors nor the people in the trial will know which treatment they are getting. The steroids or placebo will be given to the parent by an injection. When the babies are born, we will look at the results for each group and see if there are any problems. If we see that steroids work we will be able to use this drug in the NHS straight away. We hope this will be cheaper for the NHS. We will study the costs for the treatment to see if this is true. If people don’t take part in the trial, it will be up to each hospital if they offer the drug to the pregnant person as part of their ordinary maternity care.

We need to include 1,552 people in the trial and give them steroids or placebo, to see if there are any differences between the two groups. We will collect information (data) from clinical records for the parent and babies and put this in a database.

The long-term follow up for the children (age 3 – 5 years) is not included in STOPPIT-3 as the trial will only last until the children are 2 years old. We will set up a Twin Database and ask people taking part in STOPPIT-3 if we can keep their details for follow up in the future. This will also include the children’s details. The data collected as part of this trial will help future studies looking at the long- term outcomes of ACS, by linking records of trial data to long term outcome data in healthcare and education.

We hope we will be able to follow the children at various stages of development, possibly until adulthood, using health records and school information.

Public and patient involvement: We have the support of two charities who represent parents with twins, Twins Trust and the Multiple Births Foundation respectively. Parents will be asked to provide feedback on the way the trial is carried out. We’ll also ask parents about any documents produced during the trial. We will include ordinary people (lay representation) on trial oversight committees (a group of experts who advise on the progress of the trial) and set up a group of parents so we can ask them about things such as the information we give to patients and how we tell people about the results of the trial.

Thank you from the trial team:

Grantholders: Prof Sarah Stock, Dr Sarah Murray, Dr Manuela Deidda, Dr Kathleen Boyd, Prof Jane Norman, Prof John Norrie, Prof Rebecca Reynolds, Prof James Boardman, Dr Karen Luyt, Prof Asma Khalil, Prof Debra Bick, Ms Natasha Fenwick, Ms Jane Denton.

Trial manager and administrative team:
Trial Manager - Lauren Murdoch
Assistant Trial Manager – Karen Ponder
Administrator - Lorraine Adamson

Contact details:

Tel: 0131 651 9925

Email:
[email protected]
[email protected]
[email protected]

Edinburgh Clinical Trials Unit (ECTU), University of Edinburgh
Level 2, NINE Edinburgh BioQuarter, 9 Little France Road, Edinburgh EH16 4U