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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07250620
Enrollment
200
Registered
2025-11-26
Start date
2025-12-17
Completion date
2026-12-31
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Active Dilated Cm, Normal Pregnancy

Keywords

CTG, Fetal monitoring

Brief summary

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 beingImmediately after birthUsing fetal acidemia defined as (umbilical venous pH \< 7.25) as reference in detecting fetal will being and comparing results with 10-min & 30-min CTG monitoring to evaluate diagnostic accuracy of both in detecting fetal acidemia.

Contacts

Primary ContactSoliman Mohamed Alazhary, Master
Soliman.alazhary@gmail.com+20 1143883568
Backup ContactSeif Ahmed Ali, PHD
Seifali-2020@aun.edu.eg+20 1004971596

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026