Evaluation of Neonatal Acute Hypoxia at Delivery Using Fetal Physiology and Eucapnic pH Assessment

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

This study aims to improve understanding of how fetuses respond to oxygen deprivation during labor by re-evaluating cardiotocography (CTG) recordings using a physiology-based interpretation approach and comparing these findings with umbilical cord blood gas measurements at birth, including eucapnic pH assessment.

The study will include term pregnancies and combines retrospective data analysis with prospective enrollment. Researchers will investigate whether physiology-based CTG interpretation can better identify signs of fetal compromise and whether eucapnic pH may improve the distinction between respiratory and metabolic acidosis. Findings may contribute to improving fetal monitoring strategies and the assessment of newborn condition at birth.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Singleton pregnancies

Term neonates (gestational age =or> 37 weeks)

Availability of clinical data, such as

CTG tracing within 90 minutes before delivery

Disqualifiers

Major fetal anomalies

Incomplete or missing CTG or blood gas data

Elective cesarean sections without labor

Trial population

The study population consists of women with term singleton pregnancies undergoing labor and delivery at a tertiary referral center. The study includes both retrospectively identified deliveries and prospectively enrolled pregnancies with available intrapartum cardiotocography (CTG) recordings and umbilical cord arterial blood gas analysis.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Pregnant women who deliver neonates presenting hypoxia

Trial outcomes

Primary outcomes

1

Detection of fetal decompensation using physiology-based CTG interpretation

proportion of cases in which physiology-based CTG interpretation identified features of fetal decompensation not evident in conventional interpretation

Time frame
From labor admission until delivery (assessment performed using CTG recordings obtained within 90 minutes before delivery)

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: