Prediction of Late Fetal Growth Restriction Using Cerebroplacental Ratio

Study Overview
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Brief Summary
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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
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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: AC/EFW < 10th centile AC/EFW crossing centiles >2 quartiles 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 .

Official Title
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Prediction of Late Fetal Growth Restriction in Uncomplicated Pregnancies Using Cerebroplacental Ratio: a Prospective Cohort Study

Conditions
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Fetal Growth Retardation, Stillbirth, Neonatal Respiratory Failure, Neonatal Death

Intervention / Treatment
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* Diagnostic Test: Biophsical profile
* Diagnostic Test: Cerebroplacental ratio


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women<br>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 | Diagnostic Test: Biophsical profile<br>* There are five components measured during the biophysical examination. A score of 2 points is given for each component that meets criteria. The test is continued until all criteria are met or 30 minutes have elapsed. The points are then added for a possible maximum score of 10. A total score of 10 out of 10 or 8 out of 10 with normal fluid is considered normal. A score of 6 is considered equivocal, and a score of 4 or less is abnormal.<br>* Other names: BPP;Diagnostic Test: Cerebroplacental ratio<br>* CPR is the ratio of the Middle Cerebral Artery Pulsatility Index (MCA PI) to the Umbilical Artery Pulsatility Index (UA PI). The pulsatility indices will be measured from an automated trace of at least three consecutive waveforms of the relevant vessel in the absence of fetal breathing movements or uterine contractions. The angle of insonation will be as close to zero degrees as possible. The UA PI will be recorded from a free-floating section of cord, and the MCA PI will be obtained from the proximal third of the vessel (10, 14).<br>* Other names: CPR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite of adverse neonatal outcomes | Apgar score ≤7 at 5 min or resuscitation with intubation, chest compressions or medication, admission to NICU ≥ 48 hours or hypoxic ischemic encephalopathy or cerebral palsy or stillbirth or neonatal death within 28 days | Up to 48 hours After delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative delivery (instrumental and caesarean section) for intrapartum fetal compromise (IFC) | The diagnosis of IFC will be made by the treating obstetrician based on abnormal fetal heart rate patterns (classified according to National Institute for Health and Clinical excellence [NICE] guidelines ) (15) or presence of meconium stained liquor. | At time of delivery | 
| Demographic characteristics of the cohort | Demographic characteristics of the cohort | Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm) | 
| Estimated fetal weight | An ultrasonographic measurement using Hadlock formula (13) | At Ultrasound examination at Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm) | 
| Birth weight | Birth weight in kilograms | Immediatly after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebroplacental ratio, Fetal growth restriction, Term pregnancy, Doppler ultrasound