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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Singleton pregnancy.

Term gestation (37-42 weeks).

Fetus in cephalic presentation.

No known fetal chromosomal or (severe) congenital anomaly.

Disqualifiers

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.

Trial population

"Low-risk" pregnant women

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ultrasound examination in early labor

    Other intervention

    Combined trans-abdominal and trans-perineal ultrasound examination

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Term gestation1 intervention

Trial outcomes

Primary outcomes

1

Differences in VPR (Vertebro-Placental Ratio) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3

Time frame
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

1

Differences in other doppler parameters (PI VA, PI MCA, CPR) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3.

Time frame
VPR measured in early labor (=< 4cm of cervical dilatation) - perinatal outcome score assessed at delivery - timespan between both observations variable, expected <12 hours.
2

Differences in maternal and fetal characteristics between successful and unsuccessful doppler examinations (observations) of the fetal VA and MCA respectively.

Time frame
Assessed in early labor (=< 4cm of cervical dilatation)

Other outcomes

Sponsors and contacts

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