We are carrying out the C*STEROID Trial to find out whether giving mothers corticosteroid injections before having a planned caesarean section at 35 – 39+6 weeks of pregnancy will safely reduce the risk of short term breathing problems for babies. This trial will include over 2,500 mothers and their babies.

You can read about the trial in different languages at the following link: Trial information in other languages.

More than 58,000 babies are born by planned (also known as elective or pre-labour) caesarean section in New Zealand and Australia every year. Whichever way women birth there are some advantages and disadvantages for mother and baby, and this includes some disadvantages to planned caesarean section. Babies born by caesarean section before labour has started are more likely to experience short term breathing problems compared to babies born by vaginal delivery or by caesarean section after labour has started. While the overall risk of these breathing problems is low after 35 weeks gestation, we would like to assess whether giving mothers injections of corticosteroid can safely reduce this risk. If this is shown to be safe and effective it may decrease the number of babies needing breathing support and being admitted to the neonatal unit. We will also explore the effect of corticosteroids on the longer term development of children born to mothers who have participated in the trial.

Participation in this study is voluntary. If you are interested in taking part you will be provided with an information sheet and consent form to read and a member of the study team at your delivery hospital will review your eligibility to take part.

If you choose to take part you will receive two injections 24 hours apart in the week before your planned caesarean section. This will be either a corticosteroid (betamethasone) or placebo (saline, ‘salt water’). You will be asked to complete questionnaires at the time you enter the study and again six weeks after birth.

Your baby will have at least three or four blood sugar tests in the first 12 hours after birth. These require a small prick on baby’s heel to collect a few drops of blood. If your baby has a low blood sugar level this will be discussed with you and they will be treated.

Information about you and your baby/babies will be collected until six weeks after birth. We will ask to contact you from time to time until your child reaches eight years of age in order to invite you to take part in future studies to assess the later health and wellbeing of your child.

This study is designed to assess the benefits and risks of antenatal corticosteroid therapy for mothers and babies. We hope to improve the care for women and their babies in the future.

We believe that corticosteroids may reduce the risk of breathing problems and admission to the neonatal unit for breathing support. Corticosteroids may alter the chance of baby having low blood sugar levels after birth. This is a relatively common problem in newborn babies. Low blood sugars can affect baby’s longer-term health, particularly if left untreated. All babies in this study will have their blood sugar levels tested after birth and they will receive treatment if necessary.  

No health benefits or significant health harms have been seen in women receiving antenatal corticosteroids. The most common side effects are discomfort or bruising at the injection site. Rarely corticosteroids may result in gastrointestinal (tummy) upset, headache or insomnia.  

New Zealand

The C*STEROID Trial in New Zealand is led by Katie Groom (pictured above), a researcher at the Liggins Institute and an obstetrician at National Women’s Health, Auckland City Hospital. Her passion is to improve the health of New Zealand mothers and babies in an equitable way through effective clinical trials research. Katie’s work focuses on the use of antenatal corticosteroids as well as the prevention and treatment of major pregnancy complications such as preterm birth, fetal growth restriction and preeclampsia.

Katie Groom is Professor of Maternal and Perinatal Health and the Hugo Charitable Trust Fellow at the Liggins Institute, University of Auckland. She is a Subspecialist in Maternal and Fetal Medicine at National Women’s Health, Auckland City Hospital.

Australia

The C*STEROID Trial in Australia is led by Joanne Said (pictured above), the Head of the Maternal Fetal Medicine Unit at Joan Kirner Women’s & Children’s, Sunshine Hospital, Western Health, where she has successfully developed a comprehensive multidisciplinary, holistic care pathway for women with the most complex pregnancies.

Joanne Said is a Professor in the Department of Obstetrics and Gynaecology at the University of Melbourne.

Joanne Said is also the CPI for The PRECeDe Trial in Australia and New Zealand: 
The PRECeDe Trial (unimelb.edu.au)

The C*STEROID Trial is funded by grants from the Health Research Council of New Zealand (HRC), and Medical Research Future Fund (MRFF). Feasibility study: Hugo Charitable Trust, Lottery Health Research, Cure Kids, the A+ and other smaller local grants.

In developing The C*STEROID Trial we conducted a one year feasibility study at three sites in New Zealand. The feasibility study had the same inclusion criteria and trial procedures, and we asked women to share their experience in a follow-up survey after birth. Overall, 86% of women said that they would take part in the study again if they were in a similar position, and the same number said that they would recommend taking part to a friend. To read the published paper on C*STEROID Feasibility Study, follow the link here: https://bmjopen.bmj.com/content/12/9/e062309

To see the latest updates and our participants’ stories, visit our Facebook page.

To contact the C*STEROID team:

New Zealand - Research Coordinator on 022 4311 988 or email csteroid@auckland.ac.nz

Australia – email csteroid-trial@unimelb.edu.au