The Relationship Between Umbilical Cord ph and Feto-maternal Doppler Studies in Scheduled Nonlaboring Term Singleton Caesarean Deliveries

Suspended

• Conditions: Fetal Hypoxia; Fetal Conditions

• Registration Number: NCT04364308
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2020-04-19
• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-29
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The venous umbilical cord pH at birth was correlated with ultrasound doppler parameters	pre-intervention	the investigators recordered venous umbilical cord pH and all fetal doppler parameters

Trial Locations

Locations (1)

Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -; 🇮🇹 Napoli, Italia, Italy