Actively Recruiting
Doppler Findings in the Fetal Cerebral Blood Vessels (VA/MCA) Within 24 Hours Before Delivery and Relation With Perinatal Outcome
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01
120
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing blood flow patterns in the brain vessels of fetuses within 24 hours before delivery to compare those with normal and adverse perinatal outcomes. The study also explores maternal and fetal factors that might affect the success of Doppler ultrasound examinations during early labor at term. Additionally, it assesses the reliability of this ultrasound technique by checking consistency between different observers. Participants will undergo a combined trans-abdominal and trans-perineal ultrasound examination in early labor, defined as when cervical dilation is 4 cm or less. The study focuses on term pregnancies with fetuses in head-down position, and ultrasound measurements will be analyzed in relation to a perinatal outcome score assessed at delivery. The timing between ultrasound and delivery is expected to be less than 12 hours. During the study, researchers will collect ultrasound data, maternal and fetal characteristics, and perinatal outcome information. They will measure differences in vertebro-placental ratio and other Doppler parameters, and evaluate the success rate of the ultrasound exams. Participants will be monitored from early labor until delivery, and results will help understand the relationship between blood flow patterns and perinatal outcomes.
CONDITIONS
Brief Title
Doppler Findings in the Fetal Cerebral Blood Vessels (VA/MCA) Within 24 Hours Before Delivery and Relation With Perinatal Outcome.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Singleton pregnancy
- Term gestation between 37 and 42 weeks
- Fetus in cephalic (head-down) presentation
- No known fetal chromosomal or severe congenital anomalies
- Normally grown fetus with estimated fetal weight or abdominal circumference above the 10th percentile or stable growth between 30 and 37 weeks
- No pre-existing Doppler or amniotic fluid abnormalities
- Normal fetal heart rate tracing or cardiotocography indicating no pre-existing hypoxia
- Admission in early spontaneous labor or induction of labor with expected delivery within 24 hours
- Maternal age 18 years or older
- Willingness to provide written informed consent
You will not qualify if you...
- Advanced labor with more than 4 cm cervical dilatation at admission
- Severe chronic maternal medical conditions or poor obstetric history linked to higher risk of adverse outcomes, including uncontrolled hypertension, severe pre-eclampsia, uncontrolled diabetes, maternal sepsis, major antepartum hemorrhage, intra-uterine infection, or prolonged rupture of membranes over 18 hours
- Intra-uterine fetal death
- Prelabour rupture of membranes with meconium-stained amniotic fluid
- Failure to meet all inclusion criteria or refusal to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours before delivery
Participants undergo combined trans-abdominal and trans-perineal ultrasound examination of fetal cerebral blood vessels during early labor.
1 visit during early labor (in-person)
Duration - Up to 12 hours
Participants are observed for perinatal outcomes following the ultrasound examination until delivery.
Observation until delivery
Trial Site Locations
Total: 1 location
1
University Hospitals Leuven, department of obstetrics and gynaecology
Leuven, Belgium, 3000
Actively Recruiting
Research Team
B
Bram Packet
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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