An observational study in Neonatal Acidemia and Hypoxia, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
This study aims to improve understanding of how fetuses respond to oxygen deprivation during labor by re-evaluating cardiotocography (CTG) recordings using a physiology-based interpretation approach and comparing these findings with umbilical cord blood gas measurements at birth, including eucapnic pH assessment.
The study will include term pregnancies and combines retrospective data analysis with prospective enrollment. Researchers will investigate whether physiology-based CTG interpretation can better identify signs of fetal compromise and whether eucapnic pH may improve the distinction between respiratory and metabolic acidosis. Findings may contribute to improving fetal monitoring strategies and the assessment of newborn condition at birth.
Cardiotocography (CTG) is widely used for intrapartum fetal surveillance; however, traditional pattern-recognition approaches may not always reflect the underlying fetal physiological response to hypoxic stress. Recently, physiology-based CTG interpretation frameworks have been proposed to improve identification of fetal compensation and decompensation mechanisms during labor.
Similarly, conventional interpretation of umbilical cord blood gas analysis may not adequately distinguish respiratory from metabolic components of neonatal acidemia. Eucapnic pH, calculated by correcting for the respiratory component of acid-base imbalance, has been proposed as a tool to better characterize metabolic compromise at birth.
This ambispective observational study aims to re-evaluate CTG tracings obtained during labor using a physiology-based interpretative framework and to integrate these findings with arterial umbilical cord blood gas parameters, including measured pH, base excess, pCO2, and calculated eucapnic pH.
The study includes a retrospective cohort of term singleton deliveries and a prospective cohort of consecutively enrolled term pregnancies undergoing intrapartum CTG monitoring. CTG recordings will undergo blinded re-evaluation by independent reviewers using physiology-based criteria. These findings will be integrated with maternal, intrapartum, and neonatal variables to explore relationships between CTG characteristics, types of hypoxic exposure, acid-base status, and neonatal outcomes.
The study aims to determine whether physiology-based CTG interpretation identifies fetal compromise not recognized using conventional interpretation methods and to evaluate the relationship between CTG findings, eucapnic pH, and neonatal condition at birth. The results may contribute to improving understanding of intrapartum fetal adaptation and refining strategies for fetal surveillance during labor.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 79 across 277 observational studies indexed under Hypoxia.
Browse Hypoxia studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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The study population consists of women with term singleton pregnancies undergoing labor and delivery at a tertiary referral center. The study includes both retrospectively identified deliveries and prospectively enrolled pregnancies with available intrapartum cardiotocography (CTG) recordings and umbilical cord arterial blood gas analysis.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will include term singleton pregnancies undergoing labor and delivery with available intrapartum cardiotocography (CTG) recordings and umbilical cord arterial blood gas analysis. Two cohorts will be included: a retrospective cohort of eligible deliveries occurring between 2018 and 2025 and a prospective cohort of consecutively enrolled term pregnancies from 2026 onward. This is an observational study with no experimental intervention, treatment allocation, or modification of standard clinical care. The study involves collection of clinical data and re-evaluation of CTG tracings using a physiology-based interpretation framework combined with assessment of cord blood gas parameters, including eucapnic pH.
Detection of fetal decompensation using physiology-based CTG interpretation
proportion of cases in which physiology-based CTG interpretation identified features of fetal decompensation not evident in conventional interpretation
Time frame: From labor admission until delivery (assessment performed using CTG recordings obtained within 90 minutes before delivery)
Plan to share: No — Individual participant data (IPD) will not be shared because the study involves retrospective and prospective collection of sensitive clinical and perinatal data, and data sharing may not be compatible with institutional policies, participant privacy protection, and applicable data protection regulations.
Start is estimated for Oct 2026; primary completion for Dec 2028, 26 months later.
Of 125 non-industry observational studies under Hypoxia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 74. This study's planned 26 months is above that.
Counting every sponsor, half of 155 studies reached it within 14 months; a quarter within 3 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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