Which test best spots fetal distress during labor? large study pits lactate against ECG analysis
NCT ID NCT04779294
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two ways to check if a baby is getting enough oxygen during labor: measuring lactate from a tiny scalp blood sample and analyzing the fetal heart's electrical signal (STAN). Researchers will look at which method better identifies babies at risk of low oxygen, using umbilical cord blood pH after birth as the reference. The study includes about 700 full-term, single-baby pregnancies with certain risk factors. Results may help doctors choose the most accurate monitoring tool.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If one method proves superior, it could help doctors detect fetal distress more accurately during labor, potentially reducing birth complications.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly improve outcomes. Results may show no clear winner or may not apply to all pregnancies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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694 people
The number who actually took part.
- Started
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Sep 2018
- Finished
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Oct 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Women in labour who are monitored with CTG and FBS scalp lactate. CTG monitoring is achieved by an internal scalp electrode combined with a pressure-sensitive external contraction transducer. FBS is performed at the decision of the obstetrician. Capillary blood is obtained from the fetal head and analyzed with a bed-side test (Lactate Pro). The monitoring procedures described above are identical with the current clinical routine at the department. The department utilizes S31 fetal monitors (Neoventa Medical AB©, Sweden), which are equipped with the hard and software tool for ST analysis. Once the scalp electrode is attached, ST analysis will be performed and recorded continuously. ST information is blinded in labor, i.e. clinical management will only be based on CTG and FBS if indicated.
- Ages
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18 to 60 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Singleton pregnancy * Cephalic presentation * Gestational age ≥36+0 weeks at delivery * Presence of antpartum or intrapartum risk factors for fetal hypoxia according to Norwegian guidelines and therefore indication for electronic fetal monitoring with scalp electrode . Exclusion Criteria: * Multiple pregnancies * Breech presentation * Gestational age \< 36+0 weeks * Contraindications for placement of a scalp electrode (HIV or HBV or HCV pos)
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Oslo University Hospital
Oslo, 0424, Norway
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