- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07250620
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
Conditions
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
- Name: Soliman Mohamed Alazhary, Master
- Phone Number: +20 1143883568
- Email: Soliman.alazhary@gmail.com
Study Contact Backup
- Name: Seif Ahmed Ali, PHD
- Phone Number: +20 1004971596
- Email: Seifali-2020@aun.edu.eg
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.
Sponsor
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.
General 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.
- 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.
- 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.
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
Keywords
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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