Clinical trial NCT04640467: Prediction of Late Fetal Growth Restriction Using Cerebroplacental Ratio
Official title: Prediction of Late Fetal Growth Restriction in Uncomplicated Pregnancies Using Cerebroplacental Ratio: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Growth Retardation
Stillbirth
Neonatal Respiratory Failure
Neonatal Death
Keywords: Cerebroplacental ratio
Fetal growth restriction
Term pregnancy
Doppler ultrasound
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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) with cephalic presentation

Brief summary: 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

Detailed 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 .

Eligibility criteria: 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.

Primary outcomes:
measure: A composite of adverse neonatal outcomes
timeFrame: Up to 48 hours After delivery
Secondary outcomes:
measure: Operative delivery (instrumental and caesarean section) for intrapartum fetal compromise (IFC)
timeFrame: At time of delivery
measure: Demographic characteristics of the cohort
timeFrame: Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm)
measure: Estimated fetal weight
timeFrame: At Ultrasound examination at Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm)
measure: Birth weight
timeFrame: Immediatly after delivery
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women's Health Hospital, Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Mariam Sobhy, MBBCH
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Ahmed Aboelhasan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Moustafa Gadalla, MD
role: PRINCIPAL_INVESTIGATOR
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