Doppler Findings in the Fetal Cerebral Blood Vessels (VA/MCA) Within 24 Hours Before Delivery and Relation With Perinatal Outcome.
Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Oct 25, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how blood flow in the brain of a fetus changes in the hours before delivery and how these changes relate to the health of the baby after birth. The researchers want to compare the blood flow patterns between healthy and unhealthy outcomes, and they are also looking at factors that might make it easier or harder to use a special ultrasound technique called Doppler sonography during early labor. Additionally, they will check how reliable this technique is by seeing if different doctors get the same results when measuring blood flow.
To participate in this study, women must be at least 18 years old and have a single baby due between 37 and 42 weeks of pregnancy. The baby should be in the correct position for delivery, and there should be no serious health issues affecting the baby or the mother. Participants will undergo Doppler ultrasound within 24 hours of delivery, and they should be willing to provide informed consent to join the study. This research is currently recruiting participants, and it aims to gather important information that could help improve care for mothers and babies during labor.
Gender
FEMALE
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.
About Universitaire Ziekenhuizen Ku Leuven
Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Leuven, , Belgium
Patients applied
Trial Officials
Jute Richter, MD, PhD
Principal Investigator
UZ Leuven / KU Leuven
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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