Hypoxia Profiles Identified in Term Newborns With Cord pH <7.00 (RCFHypA)

December 31, 2025 updated by: University Hospital, Strasbourg, France
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Gynécologie-Obstétrique - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Georges-Emmanuel ROTH, Midwife
        • Sub-Investigator:
          • Sandra BEL, MD
        • Sub-Investigator:
          • Guillaume CAMPAGNE, Student
        • Sub-Investigator:
          • Lise LECOINTRE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The score is measured 1 minute and 5 minutes after birth.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 14, 2026

Study Registration Dates

First Submitted

December 31, 2025

First Submitted That Met QC Criteria

December 31, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9618 (Fred Hutch/University of Washington Cancer Consortium)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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