Assessing fetal blood flow patterns before delivery and their impact on outcomes
Doppler Findings in the Fetal Cerebral Blood Vessels (VA/MCA) Within 24 Hours Before Delivery and Relation With Perinatal Outcome.
This study looks at how blood flow in a baby's brain changes just before birth to see if it can help predict how the baby will do after delivery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05599178 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the differences in blood flow patterns in fetal cerebral blood vessels within 24 hours before delivery, comparing fetuses with normal and adverse perinatal outcomes. It also investigates maternal and fetal characteristics that may affect the feasibility of Doppler sonography during early labor at term. Additionally, the study aims to assess the reliability of the Doppler technique by measuring intra- and inter-observer variation among participants.
Who should consider this trial
Good fit: Ideal candidates include pregnant individuals with singleton pregnancies at term, in cephalic presentation, and without known fetal anomalies.
Not a fit: Patients in advanced labor or with severe maternal medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding of fetal well-being and help predict adverse perinatal outcomes.
How similar studies have performed: Similar studies have shown promise in using Doppler ultrasound to assess fetal well-being, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Leuven
- University Hospitals Leuven, department of obstetrics and gynaecology — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Jute Richter, MD, PhD — UZ Leuven / KU Leuven
- Study coordinator: Bram Packet
- Email: bram.packet@kuleuven.be
- Phone: 00321648824
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.