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NCT05599178
Doppler Findings in the Fetal Cerebral Blood Vessels (VA/MCA) Within 24 Hours Before Delivery and Relation With Perinatal Outcome.
Conditions: Ultrasonography, Doppler, Obstetric Labor Complications
Sex: Female
Ages: 18 Years – N/A
Enrollment: 120
Sponsor: Universitaire Ziekenhuizen KU Leuven
Summary
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.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.Assess reliability of the technique by measuring intra- and inter-observer variation in a subset of participants.
Eligibility Criteria
Inclusion Criteria:Singleton pregnancy.Term gestation (37-42 weeks).Fetus in cephalic presentation.No known fetal chromosomal or (severe) congenital anomaly.Normally grown fetus (ultrasound scan demonstrating normal fetal growth between 30-37 weeks of gestation, defined as an estimated fetal weight/abdominal circumference > 10th centile or crossing <2 quartiles compared to earlier growth ultrasound).Absence of pre-existing doppler or amniotic fluid abnormalities.Normal fetal heart rate tracing / CTG (excluding pre-existing hypoxia).Admission in early spontaneous labor or induction of labor with expected delivery < 24 hours.Maternal age >= 18 yearsWilling to give written informed consent.Exclusion Criteria: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.Patients not fulfilling all the inclusion criteria or refusing to give written informed consent.
Source: ClinicalTrials.gov (NCT05599178). StuddyBuddy aggregates publicly available trial information.