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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

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Study Contact

Study Contact

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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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
women full term pregenancy in active stage of labor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Elwani Eldremey Elsenousy, Professor, Assiut University

Publications and helpful links

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General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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