Pregnancy Trials
Comparing two methods of starting an induction of labour in pregnant women (balloon at home versus hormone gel in hospital) to assess chance of vaginal birth
The induction of labour rate in New Zealand is high. Mechanical methods of induction in hospital are safe and effective. However, most women in New Zealand have induction using pharmacological methods. Trials are needed to determine the safety and effectiveness of outpatient induction with balloon catheter. Outpatient balloon induction has the potential to give women more choice and improve satisfaction, and to save on health care costs, while maintaining safe outcomes for mothers and their babies.
This trial aims to compare two management protocols for initial management of induction of labour. To demonstrate safety, clinical effectiveness and cost effectiveness for mothers and babies who are allowed to go home after commencing a balloon induction, versus remaining in hospital after commencing a prostaglandin induction.
If outpatient balloon induction is found to be as safe and effective as inpatient prostaglandin induction in low-risk women, then district health boards can incorporate this protocol into their clinical guidelines. Moreover, this evidence-based recommendation can be added to the Auckland Consensus Guideline (2014), enabling consistency of practice across the country.
Status: Recruitment complete
Sites: Auckland, Dunedin, Hawke's Bay, Hutt Valley, North Shore, Taranaki, Tauranga, Waikato, Waitemata, Waitakere, Wellington, Whakatāne
ANZCTR number: ACTRN12616000739415
Contact: m.wise@auckland.ac.nz
Researchers are conducting 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 started this main trial they conducted the C*STEROID Feasibility Study to provide more information about how best to conduct the main trial. The Feasibility Study helped 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 support or prevent women from taking part and what factors support or prevent midwives and doctors contributing to the study. It also helped 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.
Status: Recruitment complete.
ANZCTR number: ACTRN12618002028280
Contact: csteroid@auckland.ac.nz
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.
ANZCTR number: ACTRN12618000339257
Contact: ecobabe@auckland.ac.nz
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
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
Microdrop Administration of Phenylephrine and Cyclopentolate Eye Drops in Neonates
This study aims to find out if low dose versus very low dose pupil dilating eye microdrops are effective in premature infants, and if the eye drops are associated with a low risk of harm.
Retinopathy of prematurity (ROP) is a major cause of blindness in babies born before 31 weeks gestational age or with a birth weight less than 1250 g. Because of the risk of permanent blindness, this group of premature infants have routine ROP eye examinations (ROPEE) involving administration of mydriatic (pupil dilating) eye drops.
Phenylephrine with cyclopentolate or tropicamide are the eye drop regimens used, but in neonatal units in Australia and New Zealand there is a wide variety of regimens in use. Regimens vary in concentration, drop volume and frequency of administration.
Mydriatics have been associated with clinically significant cardiovascular, respiratory and gastrointestinal adverse effects, and there is evidence low dose regimens are just as effective. Therefore, it is hoped this trial will provide guidance for clinical practice to help reduce the exposure of excessive doses that some premature infants are receiving.
Status: Recruitment completed
Sites: Wellington, Christchurch, Dunedin, Invercargill, Auckland
ANZCTR number: ACTRN12619000795190
Contact: lisa.kremer@otago.ac.nz
Newborn Infant Trials
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
The most effective and best tolerated dose of caffeine to reduce intermittent hypoxaemia
Research has led to improvements in neurodevelopmental outcomes for infants born very preterm, but there has been little research on long-term neurodevelopmental outcomes for infants born late preterm. In very preterm infants, both apnoea and intermittent hypoxaemia are common and are associated with worse neurodevelopmental outcomes. Caffeine has been shown to improve intermittent hypoxaemia in very preterm infants, but there are no data to show if this is the case in late preterm infants. This trial is designed to determine the safest and most effective dose of caffeine in late preterm infants before wider studies to investigate the effects of caffeine on neurodevelopment in this group can be initiated.
Status: Recruitment completed
Sites: Auckland, Middlemore
ANZCTR number: ACTRN12618001745235
Contact: j.alsweiler@auckland.ac.nz
PAEAN – Erythropoietin for hypoxic ischaemic encephalopathy in newborns
A lack of oxygen (hypoxia) or low blood supply (ischaemia) before or during birth can destroy cells in a newborn baby's brain. The damage caused by the lack of oxygen continues for some time afterwards. One way to try to reduce this damage is to induce hypothermia cooling the baby or just the baby's head for hours to days. Erythropoietin (Epo) given in the first week after birth shows promise as a treatment that may also help. This study is to find out
whether Epo plus induced hypothermia (cooling) of near term newborn babies who have suffered from low blood or oxygen supply to the brain at birth reduces death and disability in survivors at two years of age.
The target population is 300 newborn term or near term infants(greater than or equal to 35+0 weeks gestation) with hypoxic ischaemic encephalopathy who are receiving, or planned to receive hypothermia and who are able to be recruited in time to allow study treatment to commence before 24 hours of age.
Status: Recruitment complete
Sites: Auckland, Christchurch, Middlemore, Waikato,Wellington
ANZCTR number: ACTRN12614000669695
Contact: paean@ctc.usyd.edu.au