Metabolic AcidosisNCT05259202
Value of Fetal Scalp Lactate Sampling During Labour in Cases of Abnormal Fetal Heart Rate
An observational study of Metabolic Acidosis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
ST-analysis of the foetal ECG (STAN®) is another second line technique for intrapartum foetal monitoring. Combining ST-analysis with standard CTG interpretation aims to identify hypoxic foetuses more accurately than CTG alone. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metabolic Acidosis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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: women monitored by STAN in active labour with singleton term fetus in cephalic presentation
Who may be able to join
- patient with labor monitoring by ST segment analysis (STAN) according to current guidelines
- patient who received a fetal lactate sample for fetal heart rate classified as pathological for more than 60 minutes
Who cannot join
- STAN guidelines not respected before installation and during work
- misclassification of fetal heart rate
- obstetrical complications during labor
Trial locations and contacts
1 site in 1 country.
DUPORT-PERCIER Marie, MD contact
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
WALTZING Aude, resident, 663801641 ext. 33, a-waltzingrenault@chu-montpellier.fr
About this study
Official title: Value of Fetal Scalp Lactate Sampling During Labour in Cases of Abnormal Fetal Heart Rate During Labor Over 60 Minutes Without a Significant ST-event
ST-analysis of the foetal ECG (STAN®) is another second line technique for intrapartum foetal monitoring. Combining ST-analysis with standard CTG interpretation aims to identify hypoxic foetuses more accurately than CTG alone. The STAN® method identifies changes in the ST-interval of the foetal ECG that occur in the presence of foetalcentral hypoxia The aim of this studie is to investigate if the foetal lactate blood sampling is still useful when STAN® monitoring is already being used as a second line technique for intrapartum foetal monitoring if the fetal heart rate is abnormal without a significant ST event Nowadays in the Montpellier hospital's protocol, the investigators have to check the value of lactate sampling in case of le STAN doesn't detect an ST event.
So this studie can change the Montpellier hospital's protocol and avoid useless fetal blood sampling
- Conditions
- Metabolic Acidosis
- Keywords
- serious metabolic acidosis, T segment analysis, Blood samples, instrumental delivery, Apgar score, admission to a neonatal ward
- Medical subject headings
- Acidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of serious metabolic acidosis
the incidence of serious metabolic acidosis (defined as pH < 7 and Bdecf > 12 mmol/L in the umbilical cord artery).
Measured: day 1
Secondary outcomes (2)
Number of the instrumental delivery
Apgar score
Measured: day 1
Number of the neonatal outcome
admission to a neonatal ward
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Feb 2022
- Primary completion1 May 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic AcidosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- WALTZING Aude, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259202
- Sponsor's protocol ID
- RECHMPL22_0070
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Fetal Scalp Lactate Sampling During Labour in Cases of Abnormal Fetal Heart Rate During Labor Over 60 Minutes Without a Significant ST-event
- ClinicalTrials.gov ID
- NCT05259202
- Acronym / sponsor ID
- RECHMPL22_0070
- Conditions
- Metabolic Acidosis
- Keywords
- serious metabolic acidosis, T segment analysis, Blood samples, instrumental delivery, Apgar score, admission to a neonatal ward
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 28 Feb 2022 (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.
ST-analysis of the foetal ECG (STAN®) is another second line technique for intrapartum foetal monitoring. Combining ST-analysis with standard CTG interpretation aims to identify hypoxic foetuses more accurately than CTG alone. The STAN® method identifies changes in the ST-interval of the foetal ECG that occur in the presence of foetalcentral hypoxia The aim of this studie is to investigate if the foetal lactate blood sampling is still useful when STAN® monitoring is already being used as a second line technique for intrapartum foetal monitoring if the fetal heart rate is abnormal without a significant ST event Nowadays in the Montpellier hospital's protocol, the investigators have to check the value of lactate sampling in case of le STAN doesn't detect an ST event.
So this studie can change the Montpellier hospital's protocol and avoid useless fetal blood sampling
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women monitored by STAN in active labour with singleton term fetus in cephalic presentation
Key inclusion criteria (2 listed)
- patient with labor monitoring by ST segment analysis (STAN) according to current guidelines
- patient who received a fetal lactate sample for fetal heart rate classified as pathological for more than 60 minutes
Key exclusion criteria (3 listed)
- STAN guidelines not respected before installation and during work
- misclassification of fetal heart rate
- obstetrical complications during labor
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
the incidence of serious metabolic acidosis
Time frame: day 1
the incidence of serious metabolic acidosis (defined as pH < 7 and Bdecf > 12 mmol/L in the umbilical cord artery).
2 secondary outcomes
Number of the instrumental delivery
Time frame: day 1
Number of the neonatal outcome
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Individual participant dataSharing planned: Undecided. NC
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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. This study is not recruiting at the moment.
DUPORT-PERCIER Marie, MD contact
WALTZING Aude principal investigator
University Hospital, Montpellier
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 Metabolic Acidosis, run by University Hospital, Montpellier 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 2 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: status not confirmed, as of the sponsor's last update on 28 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact WALTZING Aude, Resident (663801641 ext. 33, a-waltzingrenault@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of serious metabolic acidosis (time frame: day 1). 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 28 Feb 2022.