Clinical trial NCT05599178: Doppler Findings in the Fetal Cerebral Blood Vessels (VA/MCA) Within 24 Hours Before Delivery and Relation With Perinatal Outcome.
Official title: Doppler Findings in the Fetal Cerebral Blood Vessels (VA/MCA) Within 24 Hours Before Delivery and Relation With Perinatal Outcome.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ultrasonography, Doppler
Obstetric Labor Complications
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: "Low-risk" pregnant women

Brief 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.


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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Differences in other doppler parameters (PI VA, PI MCA, CPR) 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.
measure: Differences in maternal and fetal characteristics between successful and unsuccessful doppler examinations (observations) of the fetal VA and MCA respectively.
timeFrame: Assessed in early labor (=< 4cm of cervical dilatation)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven, department of obstetrics and gynaecology
Study officials:
affiliation: UZ Leuven / KU Leuven
name: Jute Richter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: