UnknownNot Applicable

Value of Fetal Scalp Lactate Sampling During Labour in Cases of Abnormal Fetal Heart Rate

France100 participantsStarted 2022-02-01

Plain-language 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. 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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * 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 Exclusion criteria: * STAN guidelines not respected before installation and during work * misclassification of fetal heart rate * obstetrical complications during labor

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

the incidence of serious metabolic acidosis

Timeframe: day 1

Trial details

NCT IDNCT05259202

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-05-01

Contact for this trial

WALTZING Aude, Resident

663801641 a-waltzingrenault@chu-montpellier.fr

View on ClinicalTrials.gov More Metabolic Acidosis trials