Normal PregnancyNCT07250620
Comparison Between Using 10min CTG in Fetal Monitoring Instead of 30min Monitoring in Low Resources Overcrowded Hospitals.
An observational study of Normal Pregnancy and Labor Active Dilated Cm, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Normal Pregnancy, Labor Active Dilated Cm
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 17 Dec 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women who come to Women's Health Assiut university hospital in labor and meet the inclusion criteria after informed consent.
Who may be able to join
- 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).
Who cannot join
- • Multiple gestation.
- Known major fetal anomaly.
- Non-vertex presentation.
- Indication for continuous CTG (e.g., meconium-stained liquor, antepartum hemorrhage).
- Maternal refusal.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Normal Pregnancy, Labor Active Dilated Cm
- Keywords
- CTG, Fetal monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| women full term pregenancy in active stage of labor | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start17 Dec 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Normal PregnancyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soliman Mohamed Soliman Alazhary, Assiut University
- Investigators
- Elwani Eldremey Elsenousy, Professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250620
- Sponsor's protocol ID
- 10min CTG monitoring accuracy.
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 37194903Alfirevic 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.
PubMed 28157275Garabedian 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.
PubMed 28403965
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of 10-Minute Vs 30-Minute CTG in Intrapartum Fetal Monitoring.
- ClinicalTrials.gov ID
- NCT07250620
- Acronym / sponsor ID
- 10min CTG monitoring accuracy.
- Conditions
- Normal Pregnancy, Labor Active Dilated Cm
- Keywords
- CTG, Fetal monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 17 Dec 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women full term pregenancy in active stage of labor | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women who come to Women's Health Assiut university hospital in labor and meet the inclusion criteria after informed consent.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- • Multiple gestation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Results publication: PubMed 37194903Tomich 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.
- Results publication: PubMed 28157275Alfirevic 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.
- Results publication: PubMed 28403965Garabedian 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elwani Eldremey Elsenousy, Professor study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Pregnancy and Labor Active Dilated Cm, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soliman Mohamed Alazhary, Master (+20 1143883568, Soliman.alazhary@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07250620, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.