Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT04364308 |
| Other study ID # |
358 |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2019 |
| Est. completion date |
September 1, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
University of Campania "Luigi Vanvitelli" |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Perinatal asphyxia is a crucial reason for neonatal and childhood morbidity and death. Fetal
and neonatal acidemia can be utilised as predictors for establishing such risk. Several
researches have reported a marked relation between low values of fetal pH with short- and
long-term adverse neonatal outcomes. Umbilical cord blood gas studies (UCGS) are considered
critical data that gives an objective and certified evaluation of the oxygenation and
metabolic status of the fetus. Before birth, the physician can evaluate fetal wellness
through cardiotocography and prenatal ultrasound. Other studies had examined the role of
fetal Doppler indices before birth and proposed that fetuses with lower impedance in the
middle cerebral artery (MCA) or low cerebroplacental ratio (CPR) are at increased risk of
adverse pregnancy outcome. However, no research has ever evaluated the possibility of a
correlation between ultrasonographic fetal evaluation and fetal umbilical cord pH as a
predictor of pre-delivery fetal pH.
The goal of our study was to discovered a potential association between the venous umbilical
ph cord blood at delivery and the ultrasonographic feto-maternal doppler indices in patients
with a scheduled nonlaboring term singleton caesarean deliveries (SCD), this research is a
novel finding.
Description:
the investigators included in our study only singleton term (37 0/7 - 41 6/7 weeks of
gestation) pregnancies delivered by a scheduled nonlaboring term singleton caesarean
deliveries.
This was an observational study carried out at a single university tertiary care center
For every patient, an ultrasound examination was performed within one day of delivery and the
fetal doppler indices were recorded. The umbilical venous pH were obtained immediately after
delivery and before placental detachment with heparinized syringes
The primary endpoints were CPR, umbilical (UA) and fetal MCA arteries indices. The second
endpoints analysed when measurable were ductus venosus (DV) and uterine artery (Ut)
pulsatility indices, all indices were examined using colour Doppler ultrasound according to a
standard procedure and CPR was evaluated as the ratio between the MCA and UA pulsatility
indices.
The venous umbilical cord pH at birth was correlated with ultrasound doppler parameters,
calculating the correlation coefficient r2 and P-value. Statistical significance was fixed at
P<0.05. the investigators performed a linear regression analysis to find the association
between the different ultrasound indices and the venous pH.
