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

Obstetric Labor Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599178
• Other study ID #: S66995
• Status: Recruiting
• Start date: December 23, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Bram Packet
• Phone: 00321648824
• Email: bram.packet[@]kuleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obstetric Labor Complications

Intervention

Other:
• Ultrasound examination in early labor
Combined trans-abdominal and trans-perineal ultrasound examination

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven, department of obstetrics and gynaecology	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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)