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Clinical Trials/NCT07333599
NCT07333599
Recruiting
Not Applicable

Hypoxia Profiles Identified in Term Newborns With Cord pH <7.00

University Hospital, Strasbourg, France2 sites in 1 country400 target enrollmentStarted: April 4, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
University Hospital, Strasbourg, France
Enrollment
400
Locations
2
Primary Endpoint
Apgar score

Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
0 Days to 1 Day (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult woman (≥ 18 years)
  • Treated at Strasbourg University Hospital between January 1, 2014, and December 31, 2024
  • Singleton pregnancy
  • Cord arterial pH \< 7.00

Exclusion Criteria

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

Outcomes

Primary Outcomes

Apgar score

Time Frame: The score is measured 1 minute and 5 minutes after birth.

Apgar score: * 7 to 10 points: Healthy baby * 4 to 6 points: The baby needs some help (oxygen, stimulation, etc.) * 0 to 3 points: Urgent situation; the baby needs immediate care

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Strasbourg, France
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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