RecruitingNCT06906744RCFLoSUpdated Apr 2, 2025

Quantitative Assessment of Signal Loss in Cardiotocography Using External Recording

An observational study in Maternal Heart Rate, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-04-02.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
Started Feb 2024; still recruiting 2 years 8 months later.

Study type: Observational
Model: Case-control
Time perspective: Retrospective
Enrollment: 500
Ages: 18 Years to 45 Years
Sex: Female

Study summary

Signal loss in cardiotocography (CTG) recordings is numerous and frequent, whether due to artifacts in signal acquisition or confusion over inadvertent maternal heart rate recording, with various negative consequences for neonatal morbidity and unnecessary obstetric interventions. Data on this issue are 10 to 15 years old. CTG remains the primary method for assessing fetal well-being during labor, almost systematically.

Conditions studied

Maternal Heart Rate

Keywords

Maternal heart rate recording
Cardiotocography
Neonatal morbidity

In context

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 994 studies on the registry; 353 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: Female
Sampling method: Non-probability sample

Study population

Adult female (≥ 18 years old) with gestational age at delivery >36 weeks

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Inclusion criteria

Adult female (≥ 18 years old)
Patient treated at a hospital between February 1, 2024 and February 28, 2024
Having undergone cardiotocography in the labor and delivery room
Gestational age at delivery >36 weeks

Exclusion criteria

Exclusion Criteria:

Patient who has expressed opposition to the use of medical record data
Patient without CTG
Gestational age at delivery \<36 weeks

Study design

Observational model: Case-control
Time perspective: Retrospective
Enrollment: 500 participants (estimated)
Patient registry: No

What researchers measure

Primary outcomes

Percentage of signal loss during fetal heart rate (FHR) recording during labor.
Time frame: during labor

Study locations

1 of 1 sites recruiting

Service de Gynécologie-Obstétrique CMCO - CHU de Strasbourg - France
Strasbourg, 67091, France
- Georges-Emmanuel ROTH, Midwife · Contact · georges-emmanuel.roth@chru-strasbourg.fr · 33.3.69.55.35.46
- Georges-Emmanuel ROTH, Midwife · Principal investigator
- Armony LAURENT, Midwife · Sub investigator
- Sandra BEL, MD · Sub investigator
Recruiting

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Started Feb 2024 (actual). Primary completion is estimated for Dec 2025, 22 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 25, 2025
First posted: Apr 2, 2025
StartActual: Feb 22, 2024
Primary completionEst.: Dec 22, 2025
CompletionEst.: Dec 22, 2025
Last update: Apr 2, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06906744
Lead sponsor: University Hospital, Strasbourg, France
Responsible party: Sponsor
First posted: Apr 2, 2025
Start date: Feb 22, 2024
Primary completion: Dec 22, 2025 (estimated)
Completion: Dec 22, 2025 (estimated)
Last update: Apr 2, 2025

Study contacts

Georges-Emmanuel ROTH, Midwife

Contact

georges-emmanuel.roth@chru-strasbourg.fr

33.3.69.55.35.46

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Discussion

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