Hypoxia patterns in full-term newborns with very low umbilical cord pH
Official title: Hypoxia Profiles Identified in Term Newborns With Cord pH <7.00
Run by University Hospital, Strasbourg, France · NCT07333599 · Data updated 2026-11-12
This project tries to see if there are distinct hypoxia patterns and fetal heart-rate signs in full-term newborns whose umbilical cord arterial pH is below 7.00.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Days to 1 Day |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Status | Recruiting |
| Started | April 4, 2025 |
| Main results expected | August 2026 |
| Study ends | August 14, 2026 |
| Registry record updated | January 12, 2026 |
| Trial ID | NCT07333599 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult women (≥18 years) who delivered a singleton at term at Strasbourg University Hospital between 2014 and 2024 whose infants had an arterial cord pH below 7.00 and who have available CTG recordings.
✕Probably not a fit
Patients who are preterm (<37 weeks), have known congenital malformations, had intrauterine fetal death on admission, lack CTG recordings, or delivered outside the specified hospital or timeframe are unlikely to be included or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will perform a retrospective observational analysis of term singleton deliveries at Strasbourg University Hospital from January 1, 2014 to December 31, 2024, selecting infants with cord arterial pH <7.00. They will review cardiotocography (CTG) tracings, delivery records, and neonatal outcomes to identify profiles of hypoxia and timing relationships with clinical events. The focus is on characterizing fetal heart-rate changes and patterns associated with severe acidosis rather than testing an intervention. The analysis excludes preterm births, known congenital malformations, intrauterine fetal death on admission, and cases without CTG recordings.
Why it matters
Potential benefit: If successful, the findings could help clinicians recognize dangerous intrapartum hypoxia earlier, reduce delayed diagnoses and unnecessary obstetric interventions, and improve newborn neurological outcomes.
How similar studies have gone: Previous research linking fetal heart rate patterns to neonatal acidemia has shown mixed results with persistent inter-observer variability, so this work builds on existing but not definitive evidence.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Service de Gynécologie-Obstétrique - CHU de Strasbourg - France
Strasbourg, France Recruiting
Study contacts
- Study coordinator: Georges-Emmanuel ROTH, Midwife
- Email: georges-emmanuel.roth@chru-strasbourg.fr
- Phone: 33.3.69.55.35.46
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.