Quantitative Assessment of Signal Loss in Cardiotocograph... | NCT06906744

Studies
Quantitative Assessment of Signal Loss in Cardiotocography Using External Recording

NCT06906744

Sponsor

University Hospital, Strasbourg, France

Status

Recruiting

Last Update Posted

Apr 2, 2025Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Maternal Heart Rate

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2024Actual

Primary Completion Date

Dec 22, 2025Estimated

Completion Date

Dec 22, 2025Estimated

First Submitted Date

Mar 25, 2025

First Submission Date that Met QC Criteria

Mar 25, 2025

First Posted Date

Apr 2, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2025

Last Update Posted Date

Apr 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of signal loss during fetal heart rate (FHR) recording during labor.		during labor

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Georges-Emmanuel ROTH, Midwife	Contact	33.3.69.55.35.46		georges-emmanuel.roth@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Gynécologie-Obstétrique CMCO - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France