Quantitative Assessment of Signal Loss in Cardiotocography Using External Recording (RCFLoS)

March 25, 2025 updated by: University Hospital, Strasbourg, France
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Gynécologie-Obstétrique CMCO - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Georges-Emmanuel ROTH, Midwife
        • Sub-Investigator:
          • Armony LAURENT, Midwife
        • Sub-Investigator:
          • Sandra BEL, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2024

Primary Completion (Estimated)

December 22, 2025

Study Completion (Estimated)

December 22, 2025

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9239

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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