C*STEROID Feasibility Study
Can we safely reduce the risk of breathing problems for newborn babies by giving corticosteroid injections to their mothers before a planned caesarean section?
What is the C*STEROID Trial?
We are planning a large trial, called the C*STEROID Trial, to find out whether giving mothers corticosteroid injections before having a planned caesarean section from 35 weeks of pregnancy will safely reduce the risk of short term breathing problems for babies. This trial will include approximately 2600 mothers and their babies.
Please note: Recruitment to The C*STEROID Feasibility Study closed on Wednesday 25 March 2020 in view of Covid-19 and New Zealand’s alert level 4 status. Recruitment over the last nine months will allow us to meetour objectives for the Feasibility Study and we look forward to opening recruitment to the main C*STEROID Trial later this year.
What is the C*STEROID Feasibility Study?
Before we undertake this trial we are conducting the C*STEROID Feasibility Study to provide more information about how best to conduct the main trial. Taking part in the Feasibility Study will help us identify which women are willing to take part such a trial, the duration of follow up participants are willing to agree to, what factors that support or prevent women from taking part and what factors that support or prevent midwives and doctors contributing to the study. It will also help us work out the practicalities of the study. Results of the Feasibility Study will also contribute to the main trial.
Women undergoing a planned caesarean section at 35+0 to 39+6 weeks will be asked to participate by completing a questionnaire about their decision to take part or not take part in the study. Women who want to take part in the randomised controlled trial will also be given two injections of corticosteroid or placebo in the week before their planned caesarean section.
Why is the C*STEROID Feasibility Study and C*STEROID Trial important?
In New Zealand around 7000 babies are born by planned caesarean section each year. 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.
Who can take part in the C*STEROID Feasibility Study?
The C*STEROID Feasibility Study is taking place at National Women’s, Auckland City Hospital, Tauranga Hospital and Waikato Hospital in New Zealand. This study may be suitable for you if you are pregnant with one baby or twins and have a caesarean section planned at between 35+0 and 39+6 weeks gestation. There are some circumstances where this study is not suitable, for example if you have diabetes, if your baby/babies are very unwell or if you have already received corticosteroids in your current pregnancy.
Let your midwife or obstetrician know if you’d like to take part, or contact the C*STEROID research team to register your interest. If you are in Auckland you can contact the research midwives on 021 0831 4824 or outside of Auckland contact the research coordinator on 022 4311 988, or email us on firstname.lastname@example.org
What do I have to do to take part in the C*STEROID Feasibility Study?
- A questionnaire - You can choose to complete a questionnaire about your decision to take part in, or not take part in, the randomised clinical trial component of the C*STEROID Feasibility Study. This questionnaire will collect information on your age, ethnicity, your current and previous pregnancies and any information you have received about antenatal corticosteroids and caesarean section.
- Randomised clinical trial - If you agree to take part in the randomised controlled trial you will also receive two doses of study medication, either corticosteroid medication or an identical looking placebo, within 24 hours to 7 days before your planned birth. You will be asked to complete questionnaires at the time you enter the study and again six weeks after birth. Your baby/babies will have three or four blood sugar tests in the first 12 hours after birth. Blood sugar tests 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 he or she will be treated in the usual way. We will collect information about you and your baby/babies until you go home from hospital. We will contact you from time to time after that until your child reaches 8 years of age, to ask whether you are willing to take part in any planned follow up studies. These are optional.
Are there any risks?
Previous studies have shown no health benefits or significant health harms to women. There may be some discomfort or bruising at the injection site, however, the study medication will only be administered by an experienced health care professional. The use of maternal corticosteroids may potentially increase the risk of infection. While this has not been seen in previous trials we will collect this information to accurately assess any infection risk.
Find out more
You can email us: email@example.com
If you're in Auckland, contact the study midwives on 021 0831 4824.
If you're outside of Auckland, phone our clinical research coordinator Laura Mackay 022 4311 988.