Hypoxia Profiles Identified in Term Newborns With Cord pH <7.00

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-1
SponsorUniversity Hospital, Strasbourg, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult woman (≥ 18 years)

Treated at Strasbourg University Hospital between January 1, 2014, and December 31, 2024

Singleton pregnancy

Cord arterial pH < 7.00

Disqualifiers

Gestational age < 37 weeks

Known congenital malformation

Intrauterine fetal death diagnosed upon admission

No cardiotocographic recording

Trial population

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

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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