None listed
Conditions
Brief summary
The primary aims of the trial are (within the context of the RCT A*STEROID) 1) To evaluate the effects of betamethasone and dexamethasone on fetal cardiovascular status as assessed by the ultrasound parameters of umbilical artery Doppler, middle cerebral artery Doppler, ductus venosus Doppler, uterine artery Doppler, and myocardial performance index. 2) To evaluate the effects of betamethasone and dexamethasone on fetal cardiovascular status as assessed by computerized cardiotocograph (cCTG) using Dawes-Redman criteria. 3) To evaluate the effects of betamethasone and dexamethasone on placental weight, morphology and histological evidence of villous maturation postpartum, and correlate this with placental ultrasound and uterine artery Doppler findings.
Interventions
Dexamethasone (antenatal corticosteroid) - 2 syringes of 12 mg dexamethasone (dexamethasone sodium phosphate - a non-sulphite containing preparation) administered as 2 intramuscular injections, 24 hours apart. (Performed as part of parent A*STEROID trial, ACTRN 12608000631303 - drugs not administered by this trial's investigators)
Observational component: Fetal cardiovascular and behavioural effects of corticosteroids (as measured by ultrasound and cardiotocograph) in the first week after mater
Dexamethasone (antenatal corticosteroid) - 2 syringes of 12 mg dexamethasone (dexamethasone sodium phosphate - a non-sulphite containing preparation) administered as 2 intramuscular injections, 24 hours apart. (Performed as part of parent A*STEROID trial, ACTRN 12608000631303 - drugs not administered by this trial's investigators) Observational component: Fetal cardiovascular and behavioural effects of corticosteroids (as measured by ultrasound and cardiotocograph) in the first week after maternal corticosteroid administration. Correlation with neonatal and early childhood outcome.
Sponsors
Dr Amanda Henry
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Women are eligible for the trial if they are at risk of preterm birth at less than 34 weeks gestation, are aged 18-50, have a singleton or twin pregnancy, have no contraindications to the use of antenatal corticosteroids and give informed consent to both the A*STEROID trial and this trial.
Exclusion criteria
Women are not eligible if they have chorioamnionitis requiring urgent delivery, a higher order multiple pregnancy, have already received antenatal corticosteroids, have known fetal lung maturation, are in the second stage of labour, have an abnormal morphology scan, are taking digoxin or pure beta-blocker, have psychiatric illness precluding informed consent, or have insufficient English for valid consent.
Outcome results
None listed