C*STEROID Feasibility Study

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.

Before we undertake this trial we needed to conduct a C*STEROID Feasibility Study to provide more information about how best to conduct the main trial. The Feasibility Study helped us identify which women were willing to take part such a trial, the duration of follow up participants were willing to agree to, what factors support or prevent women from taking part and what factors support or prevent midwives and doctors contributing to the study. It also helped 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 were asked to participate by completing a questionnaire about their decision to take part or not take part in the study. Women who wanted to take part in the randomised controlled trial were also given two injections of corticosteroid or placebo in the week before their planned caesarean section.

The C*STEROID Feasibility Study took place at National Women’s, Auckland City Hospital, Tauranga Hospital and Waikato Hospital in New Zealand. This study was for women who were  pregnant with one baby or twins and had a caesarean section planned at between 35+0 and 39+6 weeks gestation. There were some circumstances where this study was not suitable, for example if the woman had diabetes, if the baby/babies was very unwell or if the woman had already received corticosteroids in their current pregnancy.

Participants could choose to complete a questionnaire about their decision to take part in, or not take part in, the randomised clinical trial component of the C*STEROID Feasibility Study. This questionnaire collected information on their age, ethnicity, current and previous pregnancies and any information already received about antenatal corticosteroids and caesarean section.

Participants who agreed to take part in the randomised controlled trial also received two doses of study medication, either corticosteroid medication or an identical looking placebo, within 24 hours to 7 days before their planned birth. They were asked to complete questionnaires at the time they entered the study and again six weeks after birth. The baby/babies had 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. Women whose babies had a low blood sugar level were treated in the usual way. We collected information about the women and their baby/babies until they left hospital, and we will contact them from time to time until the children reach 8 years of age, to ask if they are willing to take part in any planned follow up studies. These are optional.

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 was only administered by experienced health care professionals. The use of maternal corticosteroids may potentially increase the risk of infection. While this has not been seen in previous trials we collected this information to accurately assess any infection risk.

Find out more about the main C*STEROID Trial here.