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

NCT ID: NCT05599178

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-23

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Ultrasonography, Doppler Obstetric Labor Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Term gestation

Ultrasound examination in early labor

Intervention Type OTHER

Combined trans-abdominal and trans-perineal ultrasound examination

Interventions

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Ultrasound examination in early labor

Combined trans-abdominal and trans-perineal ultrasound examination

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jute Richter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven / KU Leuven

Locations

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University Hospitals Leuven, department of obstetrics and gynaecology

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Bram Packet

Role: CONTACT

00321648824

Facility Contacts

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Bram Packet, MD

Role: primary

00321648824

Other Identifiers

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S66995

Identifier Type: -

Identifier Source: org_study_id

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