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NCT Number: NCT07333599

Hypoxia Profiles Identified in Term Newborns With Cord pH <7.00

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.

Recruiting

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Key information

Age range

0 day–1 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Gynécologie-Obstétrique - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Georges-Emmanuel ROTH, Midwife

CONTACT

[email protected]

33.3.69.55.35.46

Georges-Emmanuel ROTH, Midwife

PRINCIPAL_INVESTIGATOR

Guillaume CAMPAGNE, Student

SUB_INVESTIGATOR

Lise LECOINTRE, MD

SUB_INVESTIGATOR

Sandra BEL, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Georges-Emmanuel ROTH, Midwife

CONTACT

[email protected]

33.3.69.55.35.46

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: RCFHypA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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