None listed
Conditions
Brief summary
In Australia, hypoxic peripartum death (stillbirth or neonatal death of mature infants after the onset of labour in an otherwise healthy pregnancy) is one of the top three causes of mortality in singleton term pregnancies. In addition, there is significant neonatal morbidity (neonatal encephalopathy, respiratory distress, acidosis, admission to the neonatal intensive care unit) associated with intrapartum hypoxia. Furthermore, these babies frequently require rapid delivery by emergency caesarean section which carries considerably more maternal and neonatal risk than less urgent procedures. We have found that combining the fetal cerebro-umbilical ratio (CUR) (measured by ultrasound) as a functional measure of fetal wellbeing, and maternal serum placental growth factor (PlGF) as a biomarker of placental function, at >37 weeks of gestation defines women at greatest risk of fetal compromise in labour. We therefore propose a pilot randomised controlled trial (RCT) to test whether introduction of this test can reduce intrapartum fetal compromise at term. Our primary outcome measure of fetal compromise will be a composite of emergency caesarean section for fetal compromise or severe adverse neonatal outcomes (cord arterial pH <7.1 and/or Lactate >6 mmol/L or Base Excess >12 or Apgar <5 at 5 minutes) or fetal/neonatal death. A pre-labour test which identifies babies most at risk of compromise in labour will address a critically unmet need in obstetrics as there is currently no good antenatal test for the prediction or risk assessment for intrapartum fetal compromise at term.
Interventions
Screening test at 37 weeks gestation for fetal compromise consisting of: - maternal placental growth factor blood test (PlGF) (single blood test, collected by phlebotomist or doctor, collected at pathology service or antenatal clinic setting); and - ultrasound scan of fetal dopplers, specifically the cerebro-umbilical ratio (CUR) (single USS of approximately 45mins duration, performed in antenatal clinic setting by qualified sonographer or obstetric doctor). A screen positive test result is defined as a CUR of <= 1.27 AND PlGF level <= 81 pg/ml. For participants who screen 'positive' (increased risk of fetal distress) obstetrician to recommend induction of labour within 7 days (induction will be undertaken by qualified midwife or resident/registrar/consultant, will occur in antenatal ward and birthing suite).
Sponsors
Study design
Eligibility
Inclusion criteria
Singleton pregnancy, with cephalic presentation, planning a vaginal birth.
Exclusion criteria
Multiple pregnancy, maternal BMI>40, known fetal anomaly or growth restriction, previous caesarean section, known rupture of membranes, pathological umbilical artery dopplers.