An observational study in Fetal Growth Retardation, Stillbirth and Neonatal Respiratory Failure, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2021-01-13.
Sponsored by Assiut University · Observational
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
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
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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
•Women with uncomplicated singleton pregnancy who are planning a vaginal delivery
Exclusion Criteria:
•Multiple pregnancy
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 · Diagnostic Test: Cerebroplacental ratio
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.
Also known as: BPP
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).
Also known as: CPR
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
Time frame: Up to 48 hours After delivery
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.
Time frame: At time of delivery
Demographic characteristics of the cohort
Demographic characteristics of the cohort
Time frame: 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)
Time frame: 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
Time frame: Immediatly after delivery
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Assiut University