An observational study in Fetal Hypoxia, Fetal Distress and Low Apgar Score, sponsored by Assiut University. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Assiut University · Observational
Cardiotocography (CTG) is the standard method for monitoring fetal heart rate and uterine contractions during labor to detect signs of fetal hypoxia. However, human CTG interpretation is often subjective and subject to high interobserver variability, even among experienced clinicians. Multimodal artificial intelligence (AI) models have emerged as potential diagnostic aids capable of evaluating CTG tracings. This prospective diagnostic accuracy study aims to evaluate the diagnostic performance of Gemini Flash 3.6 in interpreting intrapartum CTG recordings according to the 2015 International Federation of Gynecology and Obstetrics (FIGO) guidelines, and to compare its accuracy directly against independent human expert obstetricians.
Participants include pregnant women admitted in active labor at term with a singleton cephalic pregnancy undergoing continuous CTG monitoring. De-identified digital images of the final 60 minutes of CTG tracing prior to delivery will be independently evaluated by Gemini Flash 3.6 and three expert obstetricians. Each evaluator will classify the tracings into one of three FIGO categories: Normal, Suspicious, or Pathological. All evaluators will be blinded to clinical details, delivery outcomes, and other observers' interpretations.
The primary objective is to assess the diagnostic sensitivity of Gemini Flash 3.6 in identifying neonates with a 5-minute Apgar score less than 7. Secondary objectives include comparing the diagnostic performance of the AI model with that of individual expert obstetricians, measuring interobserver agreement among all raters, and assessing associations with 1-minute Apgar scores and umbilical artery blood gas parameters. The AI model will be used solely as an investigational research tool, and its evaluations will not be available to the clinical team or used to guide patient care.
23 studies on the registry are indexed under Fetal Hypoxia; 6 are open to participants now.
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Pregnant women admitted in active labor at term (gestational age 37+0 weeks or greater) with singleton pregnancies in cephalic presentation undergoing routine continuous intrapartum cardiotocography (CTG) monitoring at Abutig Specialized Hospital and Women's Health Hospital, Assiut University, Egypt.
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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.
Women with singleton term pregnancies (gestational age ≥ 37 + 0 weeks) in cephalic presentation admitted to the labor ward in active labor who undergo routine continuous intrapartum cardiotocography (CTG) monitoring immediately preceding delivery. De-identified digital CTG tracings from this cohort are independently evaluated by Gemini Flash 3.6 and three expert obstetricians according to the 2015 FIGO consensus guidelines, and validated against neonatal outcomes including 1-minute and 5-minute Apgar scores as well as umbilical artery blood-gas analysis where available.
Sensitivity of Gemini Flash 3.6 for Identifying Neonates With a 5-Minute Apgar Score Less Than 7
Sensitivity is defined as the percentage of neonates with a confirmed 5-minute Apgar score less than 7 who are correctly identified as having a "Pathological" CTG tracing by Gemini Flash 3.6. Intrapartum CTG tracings from the final 60 minutes of labor immediately preceding delivery are interpreted according to the 2015 FIGO guidelines. For binary diagnostic performance analysis, a "Pathological" CTG represents a positive test result, while "Normal" and "Suspicious" CTGs represent negative test results. Sensitivity is calculated as \[True Positives / (True Positives + False Negatives)\] \* 100 and reported with a 95% confidence interval.
Time frame: 5 minutes after birth
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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