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

NCT05599178 | Recruiting

• 1 other identifier: S66995
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.Assess reliability of the technique by measuring intra- and inter-observer variation in a subset of participants.

Conditions

Ultrasonography, Doppler; Obstetric Labor Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

Study Arms (1)

Term gestation

Other: Ultrasound examination in early labor

Interventions

Ultrasound examination in early labor OTHER

Combined trans-abdominal and trans-perineal ultrasound examination

Term gestation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

"Low-risk" pregnant women

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven, department of obstetrics and gynaecology

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jute Richter, MD, PhD

  UZ Leuven / KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bram Packet

CONTACT

00321648824; bram.packet@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 31, 2022
• Study Start: December 23, 2022
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

BE (1)