An Ambispective, Observational Study to Evaluate the Cases of Neonatal Acute Hypoxia at Delivery Using Fetal Physiology-Based Interpretation 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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Silvio Tartaglia, MD, PhD
- 전화번호: +390630157024
- 이메일: silvio.tartaglia@policlinicogemelli.it
연구 연락처 백업
- 이름: Alessandro Petrecca, MD
- 전화번호: +390630157024
- 이메일: alessandro.petrecca@guest.policlinicogemelli.it
연구 장소
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Lazio
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Rome, Lazio, 이탈리아, 00168
- UOC di Ostetricia e Patologia Ostetrica
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연락하다:
- Concetta Cesare
- 전화번호: +390630158531
- 이메일: att@policlinicogemelli.it
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부수사관:
- Silvio Tartaglia, MD, PhD
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부수사관:
- Alessandro Petrecca, MD
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부수사관:
- Beatrice Valentini, MD
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부수사관:
- Roberta Rullo, MD
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부수사관:
- Alice Dal Miglio, MD
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부수사관:
- Federico Quintiliani, MD
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부수사관:
- Marta Vicidomini, MD
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부수사관:
- Tullio Ghi, MD, PhD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Detection of fetal decompensation using physiology-based CTG interpretation
기간: 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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공동 작업자 및 조사자
수사관
- 연구 책임자: Tullio Ghi, Chief, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 27264
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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