Clinical Trials in set up

Here we provide details of clinical trials supported by the ON TRACK Network that will soon recruit New Zealand mothers and babies. Currently there are two trials in set up that are anticipated to open recruitment soon, these trials will recruit pregnant women.

Pregnancy Trials

The C*STEROID Trial is a New Zealand-wide, placebo-controlled, randomised trial to assess the effects of corticosteroids given to the mother prior to a planned cesarean section (CS) at or near term on neonatal and later childhood health.

In New Zealand, more than 15,000 babies are born by CS each year and rates continue to rise. Planned CS poses some risk to babies, in particular, the need for admission to the neonatal unit (NNU) for breathing support which means mothers are separated from their baby.

When given to mothers expecting a preterm birth, corticosteroid injections save babies’ lives and improve neonatal and childhood health. Many clinicians therefore now prescribe these injections before a planned CS at or near term even though there has been limited research about this. As well as benefits these injections may lower blood sugar levels in babies and so possibly cause harm. This trial aims to find out whether giving mothers corticosteroid injections before planned CS birth at 35+0 to 39+6 weeks can safely reduce the risk of breathing problems for babies.

Status: Pre-recruitment. The trial is currently going through New Zealand approvals and is anticipated to open to recruitment later this year.

ANZCTR number: ACTRN12618002028280 (Feasibility Study)

Email contact: [email protected]
PROTECT Me: Assessing Antenatal Maternal Melatonin Supplementation in Fetal Growth Restriction to Improve Neurodevelopmental Outcomes. Fetal growth restriction (FGR) complicates over 30 million pregnancies globally. It significantly increases the risk of stillbirth, preterm birth and is a recognised causal pathway to the neurodevelopmental injury underlying subsequent cognitive and behavioural impairment and cerebral palsy. This is the first phase III randomised, placebo-controlled trial assessing the use of melatonin, a cheap and widely available supplement, in pregnancies complicated by early onset FGR to protect the unborn fetal brain and improve subsequent neurodevelopmental outcomes.

Status: Pre-recruitment. The trial is going through New Zealand research approvals and is anticipated to open across various New Zealand sites shortly.

ANZCTR number: ACTRN12617001515381

Email contact: [email protected]