Doppler Findings in the Fetal Cerebral Blood Vessels (VA/MCA) Within 24 Hours Before Delivery and… (NCT05599178) | Clinical Trial Compass
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Doppler Findings in the Fetal Cerebral Blood Vessels (VA/MCA) Within 24 Hours Before Delivery and Relation With Perinatal Outcome.
Belgium120 participantsStarted 2022-12-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differences in VPR (Vertebro-Placental Ratio) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3
Timeframe: VPR measured in early labor (=< 4cm of cervical dilatation) - perinatal outcome score assessed at delivery - timespan between both observations variable, expected <12 hours.