Recruitment Completed

The following clinical trials are in follow up collecting data to analyse for the primary outcome.

Pregnancy Trials

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C*STEROID Feasibility

Researchers 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 the research team undertake this trial they conducted the C*STEROID Feasibility Study to provide more information about how best to conduct the main trial. The Feasibility Study is helping to identify which women are willing to take part in 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 to 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 took part in the randomised controlled trial were also given two injections of corticosteroid or placebo in the week before their planned caesarean section.

Recruitment to The C*STEROID Feasibility Study closed in March 2020.  The research team are now  looking forward to opening recruitment to the main C*STEROID Trial later this year.

Status: Recruitment complete.

ANZCTR number: ACTRN12618002028280

Contact: [email protected]

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The ECOBABe Study (Early Colonisation with Bacteria After Birth) is investigating whether babies born by caesarean section can be protected from a greater risk of some conditions, including childhood obesity and asthma, by being given their mothers' bacteria soon after birth.

Babies born by caesarean section miss out on the normal process of exposure to these bacteria, which happens during a vaginal birth. The bacteria may be an important part of developing babies’ digestive and immune systems. The study is trying to see if mimicking the normal process can help babies born by caesarean section.

Status: Recruitment complete. Recruitment to the study was completed earlier this year.

ANZCTR number: ACTRN12618000339257

Contact:  [email protected]

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GEMS Study

Gestational Diabetes Mellitus Trial of Diagnostic Detection Thresholds

Gestational diabetes (GDM) is a significant health problem affecting one in every 12 pregnant women or over 5,200 women in New Zealand annually. GDM has a major, negative impact on maternal and perinatal health with lifelong consequences. There is no consensus as to the degree of high blood glucose needed for the diagnosis of GDM or when treatment will be beneficial, due to a lack of high quality evidence.

This randomised trial compares important health outcomes for mothers and babies of treating women with GDM by the current criteria used in New Zealand with newly proposed criteria, that use a lower threshold and will diagnose more women as having GDM. Our results will show which diagnostic criteria is best for the health of mothers and babies, which is more cost-effective, and so provide the necessary information to guide clinical practice and policy in New Zealand, with global relevance.

Status: Recruitment complete

ANZCTR number: ACTRN12615000290594

Preterm Infant Trials

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Magnesium Sulphate at 30 to 34 weeks' gestational age: Neuroprotection Trial

Antenatal magnesium sulphate is recommended prior to preterm birth at less than 30 weeks’ gestation for neuroprotection of the fetus. Whether there are benefits at later gestations is uncertain. The primary aim of this randomised placebo controlled trial is to assess whether giving magnesium sulphate compared with placebo to women immediately prior to preterm birth between 30 and 34 weeks' gestation reduces the risks of death or cerebral palsy in their children at 2 years' corrected age.

Status: Recruitment completed.

ANZCTR number: ACTRN12611000491965

Newborn Infant Trials

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Higher IV protein intake for extremely low birthweight babies in the first week after birth on survival free from neurodevelopmental disability at 2 years' corrected age

Postnatal growth restriction, or faltering growth, is almost universal in extremely low birthweight (ELBW) babies. This is largely due to inadequate nutrition, as it is very difficult to maintain nutritional intake in the smallest babies, particularly in the first week after birth. ELBW babies are also at risk of adverse neurodevelopmental outcomes, likely also due, in part, to inadequate nutrition. Investigators have shown that increasing protein intakes in early life prevents faltering growth. They now propose to determine whether increased protein intake in early life in ELBW babies improves neurodevelopmental outcomes through a multicentre, double-blind randomised placebo-controlled trial. The findings of this trial will be of relevance to the management of all preterm babies because the intervention is simple and cheap.

Status: Recruitment completed.

ANZCTR number: ACTRN12612001084875