Clinical trial NCT04364308: The Relationship Between Umbilical Cord ph and Feto-maternal Doppler Studies in Scheduled Nonlaboring Term Singleton Caesarean Deliveries
Official title: The Relationship Between Umbilical Cord ph and Feto-maternal Doppler Studies in Scheduled Nonlaboring Term Singleton Caesarean Deliveries
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Fetal Hypoxia
Fetal Conditions
Keywords: Fetal Doppler
Ultrasound exam
cesarean delivery
umbilical cord ph
scheduled cesarean delivery
cerebroplacental ratio
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the investigators enrolled only low-risk pregnant women

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The venous umbilical cord pH at birth was correlated with ultrasound doppler parameters
timeFrame: pre-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -
state: Italia
Study officials:
References: