Maternal Heart RateRCFLoSNCT06906744
Quantitative Assessment of Signal Loss in Cardiotocography Using External Recording
An observational study of Maternal Heart Rate, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Maternal Heart Rate
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2024to 22 Dec 2025
- 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 to 45 years
- Women only
- Adult
Study population: Adult female (≥ 18 years old) with gestational age at delivery >36 weeks
Who may be able to join
- 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
Who cannot join
- Patient who has expressed opposition to the use of medical record data
- Patient without CTG
- Gestational age at delivery <36 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Gynécologie-Obstétrique CMCO - CHU de Strasbourg - France
Strasbourg, 67091
Georges-Emmanuel ROTH, Midwife, 33.3.69.55.35.46, georges-emmanuel.roth@chru-strasbourg.fr
Georges-Emmanuel ROTH, Midwife
About this study
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
- Maternal Heart Rate
- Keywords
- Maternal heart rate recording, Cardiotocography, Neonatal morbidity
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of signal loss during fetal heart rate (FHR) recording during labor.
Measured: during labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start22 Feb 2024
- Primary completion22 Dec 2025 (estimated)
- Study completion22 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Heart RateStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906744
- Sponsor's protocol ID
- 9239
- Acronym
- RCFLoS
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of Signal Loss in Cardiotocography Using External Recording
- ClinicalTrials.gov ID
- NCT06906744
- Acronym / sponsor ID
- RCFLoS / 9239
- Conditions
- Maternal Heart Rate
- Keywords
- Maternal heart rate recording, Cardiotocography, Neonatal morbidity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 22 Dec 2025 (estimated)
- Study completion
- 22 Dec 2025 (estimated)
- First posted
- 2 Apr 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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Adult female (≥ 18 years old) with gestational age at delivery >36 weeks
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patient who has expressed opposition to the use of medical record data
- Patient without CTG
- Gestational age at delivery <36 weeks
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
Percentage of signal loss during fetal heart rate (FHR) recording during labor.
Time frame: during labor
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 2 Apr 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Heart Rate, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Georges-Emmanuel ROTH, Midwife (33.3.69.55.35.46, georges-emmanuel.roth@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of signal loss during fetal heart rate (FHR) recording during labor. (time frame: during labor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2025.