NCT07250620

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Dec 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

November 16, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

December 17, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

November 16, 2025

Last Update Submit

November 23, 2025

Conditions

Keywords

CTGFetal monitoring

Outcome Measures

Primary Outcomes (1)

  • 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

    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

Study Arms (1)

women full term pregenancy in active stage of labor

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women only with full term pregnancy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • Multiple gestation.
  • Known major fetal anomaly.
  • Non-vertex presentation.
  • Indication for continuous CTG (e.g., meconium-stained liquor, antepartum hemorrhage).
  • Maternal refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

Related Links

Study Officials

  • Elwani Eldremey Elsenousy, Professor

    Assiut University

    STUDY CHAIR

Central Study Contacts

Soliman Mohamed Alazhary, Master

CONTACT

Seif Ahmed Ali, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Soliman Mohamed Alazhary

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 26, 2025

Study Start

December 17, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 26, 2025

Record last verified: 2025-11