Hypoxia Profiles Identified in Term Newborns With Cord pH <7.00

NCT07333599 | Recruiting

• 1 other identifier: 9618
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Acidemia and Hypoxia

Keywords

Hypoxia Neonatal; Neonatal acidosis; Neonatal Acidemia; Obstetrical Surgery; Newborns

Outcome Measures

Primary Outcomes (1)

• Apgar score

  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

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

Eligibility Criteria

• Age: 0 Days - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adult woman (≥ 18 years) with singleton pregnancy and cord arterial pH \< 7.00

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Gynécologie-Obstétrique - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Hypoxia; Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Georges-Emmanuel ROTH, Midwife

CONTACT

33.3.69.55.35.46; georges-emmanuel.roth@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: April 4, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 14, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

FR (1)