Prediction of Late Fetal Growth Restriction Using Cerebroplacental Ratio

• Conditions: Neonatal Respiratory Failure; Fetal Growth Retardation; Stillbirth; Neonatal Death
• Interventions: Diagnostic Test: Biophsical profile; Diagnostic Test: Cerebroplacental ratio

• Registration Number: NCT04640467
• Lead Sponsor: Assiut University

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 .

Study Timeline

• Study First Submitted: 2020-09-19
• Study First Submitted QC: 2020-11-17
• Study First Posted: 2020-11-23
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-13
• Study Start: 2021-02-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women	Biophsical profile	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
Pregnant women	Cerebroplacental ratio	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

Primary Outcome Measures

Name	Time	Method
A composite of adverse neonatal outcomes	Up to 48 hours After delivery	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

Secondary Outcome Measures

Name	Time	Method
Birth weight	Immediatly after delivery	Birth weight in kilograms
Estimated fetal weight	At Ultrasound examination at Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm)	An ultrasonographic measurement using Hadlock formula (13)
Demographic characteristics of the cohort	Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm)	Demographic characteristics of the cohort
Operative delivery (instrumental and caesarean section) for intrapartum fetal compromise (IFC)	At time of delivery	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.

Trial Locations

Locations (1)

Women's Health Hospital, Assiut University Hospital; 🇪🇬 Assiut, Egypt