Evaluation of Neonatal Acute Hypoxia at Delivery Using Fetal Physiology and Eucapnic pH Assessment (NOAH)
Neonatal Outcomes After Acute Hypoxia: Re-evaluating Cardiotocography Traces Using Fetal Physiology-Based Interpretation and Eucapnic pH Assessment
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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Silvio Tartaglia, MD, PhD
- 电话号码：+390630157024
- 邮箱：silvio.tartaglia@policlinicogemelli.it
研究联系人备份
- 姓名：Alessandro Petrecca, MD
- 电话号码：+390630157024
- 邮箱：alessandro.petrecca@guest.policlinicogemelli.it
学习地点
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Lazio
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Rome、Lazio、意大利、00168
- UOC di Ostetricia e Patologia Ostetrica
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接触：
- Concetta Cesare
- 电话号码：+390630158531
- 邮箱：att@policlinicogemelli.it
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副研究员：
- Silvio Tartaglia, MD, PhD
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副研究员：
- Alessandro Petrecca, MD
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副研究员：
- Beatrice Valentini, MD
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副研究员：
- Roberta Rullo, MD
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副研究员：
- Alice Dal Miglio, MD
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副研究员：
- Federico Quintiliani, MD
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副研究员：
- Marta Vicidomini, MD
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副研究员：
- Tullio Ghi, MD, PhD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Singleton pregnancies
- Term neonates (gestational age =or> 37 weeks)
Availability of clinical data, such as
- CTG tracing within 90 minutes before delivery
- Umbilical cord blood gas analysis (arterial sample)
- Signed informed consent (only for the prospective arm)
Exclusion Criteria:
- Major fetal anomalies
- Incomplete or missing CTG or blood gas data
- Elective cesarean sections without labor
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Pregnant women who deliver neonates presenting hypoxia
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Detection of fetal decompensation using physiology-based CTG interpretation
大体时间：From labor admission until delivery (assessment performed using CTG recordings obtained within 90 minutes before delivery)
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proportion of cases in which physiology-based CTG interpretation identified features of fetal decompensation not evident in conventional interpretation
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From labor admission until delivery (assessment performed using CTG recordings obtained within 90 minutes before delivery)
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合作者和调查者
调查人员
- 研究主任：Tullio Ghi, Chief、Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 27264
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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