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Prediction of Late Fetal Growth Restriction Using Cerebroplacental Ratio

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04640467
Enrollment
200
Registered
2020-11-23
Start date
2021-02-01
Completion date
2022-11-01
Last updated
2021-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Cerebroplacental ratio, Fetal growth restriction, Term pregnancy, Doppler ultrasound

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 .

Interventions

DIAGNOSTIC_TESTBiophsical profile

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.

DIAGNOSTIC_TESTCerebroplacental ratio

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).

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE

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.

Design outcomes

Primary

MeasureTime frameDescription
A composite of adverse neonatal outcomesUp to 48 hours After deliveryApgar 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

MeasureTime frameDescription
Operative delivery (instrumental and caesarean section) for intrapartum fetal compromise (IFC)At time of deliveryThe 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.
Demographic characteristics of the cohortGestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm)Demographic characteristics of the cohort
Estimated fetal weightAt 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)
Birth weightImmediatly after deliveryBirth weight in kilograms

Countries

Egypt

Contacts

Primary ContactMariam Sobhy, MBBCH
rrrrgds83@gmail.com+201095811120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026