RecruitingPhase 3ACTRN12620000914965

The C*STEROID Trial: Corticosteroids before planned caesarean section from 35+0 to 39+6 weeks of pregnancy.

The C*STEROID Trial. Antenatal corticosteroids prior to planned caesarean section delivery from 35+0 to 39+6 weeks gestation; a randomised controlled trial assessing the effects on neonatal respiratory morbidity and glycaemic control.

Sponsor

The University of Auckland

Enrollment

2,548 participants

Start Date

Oct 7, 2020

Study Type

Interventional

Conditions

Transient tachypnoea of the newborn Neonatal hypoglycaemia Caesarean section delivery Respiratory distress syndrome

Summary

Birth by planned caesarean section poses some risk to babies, in particular, the need for admission to the neonatal unit for breathing support. Corticosteroid injections given to mothers expecting a preterm birth reduce neonatal respiratory morbidity but is not known if corticosteroids before a planned caesarean section at or near term have the same effect. Limited research suggests that as well as benefits on babies’ breathing these injections may lower babies’ blood sugar levels and so possibly cause harm. The C*STEROID Trial is a multi-centre, placebo-controlled, randomised trial to assess the effects of corticosteroids given to mothers before a planned caesarean section at or near term on neonatal and childhood health.

Eligibility

Sex: Females

Plain Language Summary

Simplified for easier understanding

When babies are born by planned caesarean section, they miss out on the hormonal and physical changes that happen during labour — changes that help prepare the lungs for breathing. As a result, some babies born by planned caesarean have trouble breathing at birth and may need time in the neonatal unit for breathing support. Corticosteroid injections given to mothers before a premature birth are known to help babies' lungs mature, but it's not clear whether they also help for planned caesareans at or near full term (35 to 40 weeks). The C*STEROID Trial is a large multi-centre, randomised, placebo-controlled study that will find out whether giving corticosteroid injections to mothers one to seven days before a planned caesarean section at 35 to nearly 40 weeks gestation reduces the risk of breathing problems in their babies. Researchers will also track longer-term child health outcomes to make sure the treatment is safe. You may be eligible if you are pregnant with a singleton or twin pregnancy, your baby is alive, you are between 35 and nearly 40 weeks pregnant, and your caesarean is planned at least 24 hours but less than 7 days away. Women with diabetes (pre-existing or gestational) or a major fetal abnormality, or who have already received corticosteroid injections in this pregnancy, are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Two doses of 11.4mg betamethasone by intramuscular injection into the thigh, arm or buttock, 24 hours apart given within seven days of planned caesarean section. Adherence will be assessed by review o

Locations(23)

Royal Hospital for Women - Randwick

NSW,QLD,SA,VIC, Australia

The Royal Women's Hospital - Parkville

NSW,QLD,SA,VIC, Australia

St George Hospital - Kogarah

NSW,QLD,SA,VIC, Australia

Joan Kirner Women’s and Children’s Hospital - St Albans

NSW,QLD,SA,VIC, Australia

Mercy Hospital for Women - Heidelberg

NSW,QLD,SA,VIC, Australia

Royal North Shore Hospital - St Leonards

NSW,QLD,SA,VIC, Australia

Box Hill Hospital - Box Hill

NSW,QLD,SA,VIC, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,SA,VIC, Australia

Womens and Childrens Hospital - North Adelaide

NSW,QLD,SA,VIC, Australia

Ballarat Health Services (Base Hospital) - Ballarat Central

NSW,QLD,SA,VIC, Australia

Liverpool Hospital - Liverpool

NSW,QLD,SA,VIC, Australia

Monash Medical Centre - Clayton campus - Clayton

NSW,QLD,SA,VIC, Australia

The Northern Hospital - Epping

NSW,QLD,SA,VIC, Australia

Townsville University Hospital - Douglas

NSW,QLD,SA,VIC, Australia

Ipswich Hospital - Ipswich

NSW,QLD,SA,VIC, Australia

Epworth Freemasons (Clarendon Street) - East Melbourne

NSW,QLD,SA,VIC, Australia

Djerriwarrh Health Service - Bacchus Marsh - Bacchus Marsh

NSW,QLD,SA,VIC, Australia

Barwon Health - Geelong Hospital campus - Geelong

NSW,QLD,SA,VIC, Australia

Campbelltown Hospital - Campbelltown

NSW,QLD,SA,VIC, Australia

Fiona Stanley Hospital - Murdoch

NSW,QLD,SA,VIC, Australia

John Hunter Hospital - New Lambton

NSW,QLD,SA,VIC, Australia

Mater Mother's Hospital - South Brisbane

NSW,QLD,SA,VIC, Australia

Auckland, Waikato, Wellington, Christchurch, Whangarei, New Zealand

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ACTRN12620000914965