Doppler Findings in the Fetal Cerebral Blood Vessels (VA/MCA) Within 24 Hours Before Delivery and Relation With Perinatal Outcome.

Universitaire Ziekenhuizen KU Leuven1 site in 1 country120 target enrollmentDecember 23, 2022

ConditionsUltrasonography, Doppler Obstetric Labor Complications

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ultrasonography, Doppler
Sponsor: Universitaire Ziekenhuizen KU Leuven
Enrollment: 120
Locations: 1
Primary Endpoint: Differences in VPR (Vertebro-Placental Ratio) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.
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.
Assess reliability of the technique by measuring intra- and inter-observer variation in a subset of participants.

Registry

clinicaltrials.gov

Start Date

December 23, 2022

End Date

December 31, 2025

Last Updated

last year

Study Type

Observational

Sex

Female

Investigators

Sponsor

Universitaire Ziekenhuizen KU Leuven

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Differences in VPR (Vertebro-Placental Ratio) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3

Time Frame: VPR measured in early labor (=< 4cm of cervical dilatation) - perinatal outcome score assessed at delivery - timespan between both observations variable, expected <12 hours.

Secondary Outcomes

Differences in other doppler parameters (PI VA, PI MCA, CPR) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3.(VPR measured in early labor (=< 4cm of cervical dilatation) - perinatal outcome score assessed at delivery - timespan between both observations variable, expected <12 hours.)
Differences in maternal and fetal characteristics between successful and unsuccessful doppler examinations (observations) of the fetal VA and MCA respectively.(Assessed in early labor (=< 4cm of cervical dilatation))