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Prediction of Late Fetal Growth Restriction Using Cerebroplacental Ratio

A

Assiut University

Status

Unknown

Conditions

Neonatal Respiratory Failure
Neonatal Death
Fetal Growth Retardation
Stillbirth

Treatments

Diagnostic Test: Biophsical profile
Diagnostic Test: Cerebroplacental ratio

Study type

Observational

Funder types

Other

Identifiers

NCT04640467
CPR in late growth restriction

Details and patient eligibility

About

To investigate the screening performance of CPR and biophysical profile score for the prediction of composite of adverse neonatal morbidity and mortality and operative delivery (CS or instrumental) for intrapartum fetal distress in low-risk pregnancies

Full description

Fetal growth is a dynamic process and its assessment requires multiple observations over time. In most women, placental function is sufficient to allow appropriate fetal growth throughout pregnancy, however in some, it may be not near term or during labor leading to intrapartum compromise Small for gestational age (SGA) is estimated fetal weight (EFW) or abdominal circumference (AC) below the 10th percentile of given reference ranges Fetal growth restriction (FGR) is fetus that has not achieved its growth potential. There are early-onset (< 32 weeks) and late-onset (≥ 32 weeks) types. Late FGR is defined as

  • AC/EFW < 3rd centile Or at least two out of three of:
  1. AC/EFW < 10th centile
  2. AC/EFW crossing centiles >2 quartiles
  3. Cerebroplacental ratio (CPR) <5th centile or Umbilical artery Pusitility Index(UAPI )>95th centile FGR fetuses will not necessarily be SGA at delivery and vice versa. In fact, most SGA are likely to be 'constitutionally' small CPR is the ratio of the Middle cerebral artery Pulsatility Index (MCAPI) to (UAPI). The CPR gradually rises until around the 34th week and subsequently slowly declines until term. Its use has been echoed recently because of association of an abnormal ratio with fetal distress in labor requiring emergency cesarean section , a lower cord pH, admission to the intensive care unit and poor neurological outcomes The biophysical profile (BPP) abnormalities that characterize late FGR include alteration of fetal breathing, oligohydramnios and loss of fetal heart rate reactivity on conventional cardiotocography ( CTG). It seems that BPP becomes abnormal only shortly before stillbirth .

Enrollment

200 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

  • •Women with uncomplicated singleton pregnancy who are planning a vaginal delivery

    • Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm)
    • Cephalic presentation

Exclusion criteria

  • •Multiple pregnancy

    • known SGA fetus.
    • Medical disorders with pregnancy: diabetes mellitus, hypertension, pre-eclampsia
    • Known fetal anomaly or aneuploidy or stillbirth.
    • Any contraindication of vaginal delivery eg. placenta previa.

Trial design

200 participants in 1 patient group

Pregnant women
Description:
Women with uncomplicated singleton pregnancy who are planning a vaginal delivery, gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm) and cephalic presentation
Treatment:
Diagnostic Test: Cerebroplacental ratio
Diagnostic Test: Biophsical profile

Trial contacts and locations

1

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Central trial contact

Mariam Sobhy, MBBCH

Data sourced from clinicaltrials.gov

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