NCT04364308

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

April 19, 2020

Last Update Submit

November 23, 2023

Conditions

Keywords

Fetal DopplerUltrasound examcesarean deliveryumbilical cord phscheduled cesarean deliverycerebroplacental ratio

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Fetal ultrasound and its parameters

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsthe investigators enrolled only pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

the investigators enrolled only low-risk pregnant women

You may qualify if:

  • singleton term (37 0/7 - 41 6/7 weeks of gestation) pregnancies delivered by a scheduled nonlaboring term singleton caesarean deliveries

You may not qualify if:

  • Pregnancies complicated by fetal malformations, stillbirth, preterm deliveries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -

Napoli, Italia, 80138, Italy

Location

MeSH Terms

Conditions

Fetal Hypoxia

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, research , gynecology and obstetrics, Principal Investigator

Study Record Dates

First Submitted

April 19, 2020

First Posted

April 28, 2020

Study Start

April 1, 2019

Primary Completion

April 19, 2020

Study Completion

September 1, 2024

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations