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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.


Recruitment information / eligibility

Status Suspended
Enrollment 100
Est. completion date September 1, 2024
Est. primary completion date April 19, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 44 Years
Eligibility Inclusion Criteria: - singleton term (37 0/7 - 41 6/7 weeks of gestation) pregnancies delivered by a scheduled nonlaboring term singleton caesarean deliveries Exclusion Criteria: - Pregnancies complicated by fetal malformations, stillbirth, preterm deliveries.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Fetal Echography
Fetal ultrasound and its parameters

Locations

Country Name City State
Italy Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn - Napoli Italia

Sponsors (1)

Lead Sponsor Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary The venous umbilical cord pH at birth was correlated with ultrasound doppler parameters the investigators recordered venous umbilical cord pH and all fetal doppler parameters pre-intervention
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