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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstetric Labor Complications; Ultrasonography, Doppler
• Intervention / Treatment: Other: Ultrasound examination in early labor

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Bram Packet; Phone Number: 00321648824; Email: bram.packet@kuleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • University Hospitals Leuven, department of obstetrics and gynaecology
    • Contact: Bram Packet, MD; Phone Number: 00321648824

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

"Low-risk" pregnant women

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Term gestation	Other: Ultrasound examination in early labor; Combined trans-abdominal and trans-perineal ultrasound examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Jute Richter, MD, PhD, UZ Leuven / KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2022
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications
• Other Study ID Numbers: S66995

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No