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

November 23, 2025 updated by: Soliman Mohamed Soliman Alazhary, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All women who come to Women's Health Assiut university hospital in labor and meet the inclusion criteria after informed consent.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
women full term pregenancy in active stage of labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Using 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.
Immediately after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Elwani Eldremey Elsenousy, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 17, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 23, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 23, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 10min CTG monitoring accuracy.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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