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

Recruiting

• Conditions: Ultrasonography, Doppler; Obstetric Labor Complications

• Registration Number: NCT05599178
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-31
• Study Start: 2022-12-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in VPR (Vertebro-Placental Ratio) 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.

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University Hospitals Leuven, department of obstetrics and gynaecology; 🇧🇪 Leuven, Belgium