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

NCT ID: NCT07250620

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-17

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Normal Pregnancy Labor Active Dilated Cm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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women full term pregenancy in active stage of labor

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Soliman Mohamed Soliman Alazhary

Dr.Soliman Mohamed Alazhary

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elwani Eldremey Elsenousy, Professor

Role: STUDY_CHAIR

Assiut University

Central Contacts

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Soliman Mohamed Alazhary, Master

Role: CONTACT

+20 1143883568

Seif Ahmed Ali, PHD

Role: CONTACT

+20 1004971596

References

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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.

Reference Type RESULT
PMID: 37194903 (View on PubMed)

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.

Reference Type RESULT
PMID: 28157275 (View on PubMed)

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.

Reference Type RESULT
PMID: 28403965 (View on PubMed)

Related Links

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Other Identifiers

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10min CTG monitoring accuracy.

Identifier Type: -

Identifier Source: org_study_id

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