About this trial
1. Assess differences in flow patterns in the fetal cerebral blood vessels within 24 hours before delivery between fetuses with a normal vs. adverse perinatal outcome. 2. Explore maternal and/or fetal characteristics that might influence technical feasibility of doppler sonography of the fetal cerebral blood vessels in early labor at term. 3. Assess reliability of the technique by measuring intra- and inter-observer variation in a subset of participants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Singleton pregnancy.
Term gestation (37-42 weeks).
Fetus in cephalic presentation.
No known fetal chromosomal or (severe) congenital anomaly.
Disqualifiers
Advanced labor (> 4cm of cervical dilatation) at the time of admission on the labor ward.
Severe pre-existing chronic maternal medical condition or poor obstetric history/antenatal complications associated with increased risk of adverse perinatal outcome (non-exhaustive e.g.: uncontrolled chronic hypertension, severe pre-eclampsia, uncontrolled (gestational) diabetes, maternal sepsis, major antepartum haemorrhage, intra-uterine infection, prolonged rupture of membranes > 18 hours, etc.).
Intra-uterine fetal demise / death.
Prelabour rupture of membranes with meconium-stained amniotic fluid.
Trial population
"Low-risk" pregnant women
Trial design
Cohort
Prospective
Treatments tested in this trial
Ultrasound examination in early labor
Other interventionCombined trans-abdominal and trans-perineal ultrasound examination
Treatment groups
Trial outcomes
Primary outcomes
Differences in VPR (Vertebro-Placental Ratio) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3
Secondary outcomes
Differences in other doppler parameters (PI VA, PI MCA, CPR) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3.
Differences in maternal and fetal characteristics between successful and unsuccessful doppler examinations (observations) of the fetal VA and MCA respectively.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.