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RecruitingNCT05599178Updated Jul 1, 2024

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

An observational study in Ultrasonography, Doppler and Obstetric Labor Complications, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-01.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Dec 2022; still recruiting 3 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
Female
01

Study 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.
02

Conditions studied

  • Ultrasonography, Doppler
  • Obstetric Labor Complications
03

In context

Obstetric Labor Complications

89 studies on the registry are indexed under Obstetric Labor Complications; 25 are open to participants now.

This study's planned enrollment of 120 is below the median of 178 across 26 observational studies indexed under Obstetric Labor Complications.

Browse Obstetric Labor Complications studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

"Low-risk" pregnant women

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • Term gestation

    Other: Ultrasound examination in early labor

Interventions

  • OtherUltrasound examination in early labor

    Combined trans-abdominal and trans-perineal ultrasound examination

06

What researchers measure

Primary outcomes

  1. 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

  1. Differences in other doppler parameters (PI VA, PI MCA, CPR) 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.

  2. Differences in maternal and fetal characteristics between successful and unsuccessful doppler examinations (observations) of the fetal VA and MCA respectively.

    Time frame: Assessed in early labor (=< 4cm of cervical dilatation)

07

Study locations

1 of 1 sites recruiting
  • University Hospitals Leuven, department of obstetrics and gynaecology
    Leuven, 3000, Belgium
    • Bram Packet, MD · Contact · 00321648824
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05599178
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Oct 31, 2022
Start date
Dec 23, 2022
Primary completion
Sep 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jul 1, 2024

Study contacts

Bram Packet
Contact
bram.packet@kuleuven.be
00321648824
Jute Richter, MD, PhD
principal investigator · UZ Leuven / KU Leuven

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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