NCT05599178 Doppler Findings in the Fetal Cerebral Blood Vessels (VA/MCA) Within 24 Hours Before Delivery and Relation With Perinatal Outcome.
| NCT ID | NCT05599178 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Ultrasonography, Doppler |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-12-23 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2022-12-23 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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 years * Willing 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.
Contact & Investigator
Jute Richter, MD, PhD
PRINCIPAL INVESTIGATOR
UZ Leuven / KU Leuven
Frequently Asked Questions
Who can join the NCT05599178 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ultrasonography, Doppler. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05599178 currently recruiting?
Yes, NCT05599178 is actively recruiting participants. Contact the research team at bram.packet@kuleuven.be for enrollment information.
Where is the NCT05599178 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT05599178 clinical trial?
NCT05599178 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Jute Richter, MD, PhD at UZ Leuven / KU Leuven. The trial plans to enroll 120 participants.