Actively Recruiting

Age: 0Days - 1Day
All Genders
NCT07333599

Hypoxia Profiles Identified in Term Newborns With Cord pH <7.00

Led by University Hospital, Strasbourg, France · Updated on 2026-01-12

400

Participants Needed

1

Research Sites

71 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Severe neonatal acidosis is an identified risk factor for neonatal encephalopathies and severe neurological sequelae such as cerebral palsy. While intrapartum origin of such deterioration is rare (approximately 20% of adverse outcomes in term infants), screening for hypoxia that can lead to the development of severe acidosis remains inadequate. This results in both delays in diagnosis and/or intervention, and a parallel increase in obstetric interventions (cesarean sections and operative vaginal deliveries) sometimes performed with inappropriate indications, thus contributing to unnecessary maternal and neonatal comorbidities. Difficulties in analyzing fetal heart rate (FHR) patterns are identified as an independent risk factor, particularly due to significant inter- and intra-observer variability, in an examination that is nevertheless central to assessing fetal well-being during labor. An FHR analysis based on a thorough understanding of the physiology of fetal adaptation to hypoxia could allow for better recognition of situations where fetal compensation for hypoxic stress is no longer possible, when adaptive mechanisms are exhausted. Given that FHR interpretation errors are implicated in 35 to 50% of adverse neonatal outcomes (peripartum death, early neonatal death, or irreversible brain damage), the preventability of these traumatic complications for families is systematically called into question. Furthermore, recent data suggest that defining hypoxia profiles associated with tracing characteristics would allow for more accurate identification of these situations, and for improved use of intervention in a more appropriate manner in terms of time and resources, in an attempt to reduce the incidence of neonatal complications of hypoxic origin involved in the development of severe neurological sequelae.

CONDITIONS

Official Title

Hypoxia Profiles Identified in Term Newborns With Cord pH <7.00

Who Can Participate

Age: 0Days - 1Day
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult woman (≥ 18 years)
  • Treated at Strasbourg University Hospital between January 1, 2014, and December 31, 2024
  • Singleton pregnancy
  • Cord arterial pH < 7.00
Not Eligible

You will not qualify if you...

  • Gestational age < 37 weeks
  • Known congenital malformation
  • Intrauterine fetal death diagnosed upon admission
  • No cardiotocographic recording

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Service de Gynécologie-Obstétrique - CHU de Strasbourg - France

Strasbourg, France, 67091

Actively Recruiting

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Research Team

G

Georges-Emmanuel ROTH, Midwife

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Hypoxia Profiles Identified in Term Newborns With Cord pH <7.00 | DecenTrialz