Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT04640467
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:
NCT04640467
Study Brief:
Protocol Section:
NCT04640467