PRECeDe information for clinicians and midwives
Can corticosteroid injections administered to women with diabetes before a planned Caesarean section safely reduce the risk of breathing problems for newborn babies?
Background
The PRECeDe Trial is a randomised, double blind, placebo-controlled trial of antenatal corticosteroids prior to planned, pre-labour, elective CS between 35+0–39+6 weeks in women with gestational or pre-gestational diabetes.
The aim of the PRECeDe Trial is to find out whether giving pregnant women with diabetes corticosteroid injections before having a planned Caesarean section will safely reduce the risk of short-term breathing problems for babies.
The prevalence of diabetes in pregnancy, particularly gestational and Type 2, is increasing rapidly worldwide, accounting for 25% of all births at Western Health, Melbourne in 2020. Birth by Caesarean section (CS) is also on the rise, with one-third of all babies in Australia now born by CS. Women whose pregnancies are complicated by diabetes are more likely to deliver by CS than women without diabetes.
Compared to vaginal birth and CS in women without diabetes, CS in women with diabetes poses additional risks to baby due to respiratory morbidity. Fortunately, death from respiratory morbidity is rare in babies born at or near term; however, it may result in separation from the mother, invasive treatments, prolonged hospital stays, and/or lower rates of breastfeeding.
Maternal administration of corticosteroids prior to preterm birth before 35+0 weeks gestation provides protection against respiratory morbidity due to both respiratory distress syndrome and transient tachypnoea, perinatal death and neonatal adverse outcomes with little or no evidence of later harm.
What is less clear is if their use at gestational ages ≥35+0 weeks, specifically prior to planned CS, provides benefit without harm. Women with diabetes have been specifically excluded from most trials investigating antenatal corticosteroids, so we have no reliable data to inform practice for these women whose babies are most at risk for respiratory morbidity.
Corticosteroids before late preterm birth may be associated with an increased risk of neonatal hypoglycaemia and later developmental delay. We don’t yet know what the longer-term effects of corticosteroid exposure between 35+0–39+6 weeks may be on children or their mothers.
Given the rising rates of both diabetes in pregnancy and elective CS, there is an urgent need to provide the strongest level of evidence regarding the balance of benefits and risks of antenatal corticosteroids for women with diabetes, and their babies, born by elective CS. The PRECeDe trial is designed to provide this evidence.
What does PRECeDe involve for women?
The PRECeDe research team and local clinicians will approach women and coordinate the study procedures as follows:
- Invite eligible women to participate and obtain written consent
- Questionnaires at study entry and 6 weeks after delivery
- Two betamethasone or placebo injections ≥24 hours and <7 days prior to planned CS, given 24 hours apart
- Provide guidance and support for maternal hyperglycaemia aiming for euglycaemia if possible.
- Neonatal blood glucose monitoring according to the local practice guideline for monitoring neonatal hypoglycaemia in infants born to mothers with diabetes.
The remainder of clinical care will continue as usual.
Newsletter
Access the monthly PRECeDe newsletter here.
Contact us
The PRECeDe Clinical Research Coordinators can be contacted by email at precede-trial@unimelb.edu.au or by phone +61 412 019 915.
For urgent clinical enquiries, please contact the Principal Investigator Professor Joanne Said directly at jsaid@unimelb.edu.au.