Doppler Findings in the Fetal Cerebral Blood Vessels (VA/MCA) Within 24 Hours Before Delivery and Relation With Perinatal Outcome.
NCT ID: NCT05599178
Last Updated: 2024-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2022-12-23
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Term gestation
Ultrasound examination in early labor
Combined trans-abdominal and trans-perineal ultrasound examination
Interventions
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Ultrasound examination in early labor
Combined trans-abdominal and trans-perineal ultrasound examination
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Jute Richter, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven / KU Leuven
Locations
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University Hospitals Leuven, department of obstetrics and gynaecology
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Bram Packet, MD
Role: primary
Other Identifiers
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S66995
Identifier Type: -
Identifier Source: org_study_id
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