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Not yet recruiting NCT07250620

Comparison Between Using 10min CTG in Fetal Monitoring Instead of 30min Monitoring in Low Resources Overcrowded Hospitals.

— Observational Normal Pregnancy Labor Active Dilated Cm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Normal Pregnancy, Labor Active Dilated Cm. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Diagnostic Accuracy of 10-Minute Vs 30-Minute CTG in Intrapartum Fetal Monitoring.

Overview

Cardiotocography (CTG) is a cornerstone of intrapartum fetal monitoring but requires a minimum of 30 minutes for a reliable trace, creating a significant bottleneck in high-volume, low-resource settings like Egypt As it is time-consuming and resource intensive. This leads to delays in care and increased workload for healthcare providers. A shortened, yet accurate, CTG protocol could drastically improve workflow and resource allocation without compromising fetal safety.

Detailed description

In Egypt, labor wards in tertiary hospitals are often overcrowded with limited CTG machines and midwives. The requirement of a minimum 30-minute CTG trace creates bottlenecks in care and increases staff workload. Previous studies suggest that the first 10 minutes of a CTG may capture the essential features of fetal well-being. If validated, a shortened CTG could improve efficiency in high-volume maternity units without compromising neonatal outcomes. Using umbilical venous pH as the gold standard for fetal acid-base status, this study will directly compare the diagnostic accuracy of a 10-minute versus a 30-minute CTG protocol in low-risk laboring women. The aim is to evaluate whether a 10-minute CTG tracing is non-inferior to the standard 30 minute CTG in fetal assessment and predicting fetal acid-base status (umbilical venous pH) in term, low-risk pregnancies during the active first stage of labor.

Primary outcome measures

  • To compare the diagnostic accuracy (sensitivity, specificity, PPV, NPV) of a 10 minute CTG versus a standard 30-minute CTG in fetal monitoring and well being [Time frame: Immediately after birth]

Eligibility criteria

Inclusion criteria

  • Singleton pregnancy.
  • Gestational age ≥ 37 weeks.
  • Vertex presentation.
  • Active first stage of labor (cervical dilation ≥ 4 cm).
  • Low-risk pregnancy (no hypertension, diabetes, IUGR, or other significant complications).

Exclusion criteria

  • • Multiple gestation.
  • Known major fetal anomaly.
  • Non-vertex presentation.
  • Indication for continuous CTG (e.g., meconium-stained liquor, antepartum hemorrhage).
  • Maternal refusal.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Tomich MF, Leoni RS, Meireles PT, Petrini CG, Araujo Junior E, Peixoto AB. Accuracy of intrapartum cardiotocography in identifying fetal acidemia by umbilical cord blood analysis in low-risk pregnancies. Rev Assoc Med Bras (1992). 2023 May 15;69(6):e20221182. doi: 10.1590/1806-9282.20221182. eCollection 2023. PMID 37194903
  • Alfirevic Z, Devane D, Gyte GM, Cuthbert A. Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour. Cochrane Database Syst Rev. 2017 Feb 3;2(2):CD006066. doi: 10.1002/14651858.CD006066.pub3. PMID 28157275
  • Garabedian C, De Jonckheere J, Butruille L, Deruelle P, Storme L, Houfflin-Debarge V. Understanding fetal physiology and second line monitoring during labor. J Gynecol Obstet Hum Reprod. 2017 Feb;46(2):113-117. doi: 10.1016/j.jogoh.2016.11.005. Epub 2017 Jan 30. PMID 28403965

Identifiers

NCT: NCT07250620 · 10min CTG monitoring accuracy.

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗