Hypoxia Profiles Identified in Term Newborns With Cord pH <7.00

NCT ID: NCT07333599

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-04
• Study Completion Date: 2026-08-14

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 1 Day
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de Gynécologie-Obstétrique - CHU de Strasbourg - France

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Georges-Emmanuel ROTH, Midwife

Role: CONTACT

georges-emmanuel.roth@chru-strasbourg.fr

33.3.69.55.35.46

Facility Contacts

Georges-Emmanuel ROTH, Midwife

Role: primary

georges-emmanuel.roth@chru-strasbourg.fr

33.3.69.55.35.46

Other Identifiers

9618

Identifier Type: -

Identifier Source: org_study_id