Trial reportBJOG : an international journal of obstetrics and gynaecology2025
Digital Foetal Scalp Stimulation Versus Foetal Blood Sampling to Assess Foetal Well-Being in Labour: A Multicentre Randomised Controlled Trial.
Trial report in BJOG : an international journal of obstetrics and gynaecology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05306756 (Fetal Scalp Stimulation), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Fetal Scalp Stimulation (FSS) Versus Fetal Blood Sampling (FBS) to Assess Fetal Wellbeing in Labour - a Multi-centre Randomised Controlled Trial.
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
objectiveTo establish whether digital foetal scalp stimulation (dFSS) performs better than foetal blood sampling (FBS) in terms of reducing the rate of caesarean section (CS) in labour, without adversely affecting perinatal outcomes.
designA multicentre parallel-group randomised controlled trial.
settingMaternity centres in Ireland. POPULATION: The study aimed to randomise 2500 nulliparous women who required a second-line test of foetal well-being in labour due to abnormal cardiotocography (CTG).
methodsParticipants were randomly allocated to dFSS or FBS in a 1:1 ratio. Analysis was according to the published protocol and included a meta-analysis of the pilot study data and trial data.
main outcome measuresThe primary outcome was CS.
resultsDue to lower-than-expected randomisations, the trial concluded early. Of 534 consented participants, 124 had a second-line test of foetal well-being in labour and 43 (34.7%) were randomised; 20 to dFSS and 23 to FBS. The rate of CS was 40.0% (8/20) in the dFSS group and 47.8% (11/23) in the FBS group (absolute difference 7.8%; OR 0.73, 95% CI 0.22-2.44). The rate of CS was lower in the dFSS group when the trial data were included in a meta-analysis with the pilot data (n = 50), although the confidence limits were wide (OR 0.41, 95% CI 0.17-0.96). There was no significant difference in rates of adverse perinatal and maternal outcomes. Of the nonrandomised participants who received a second-line test, 65% (53/81) received dFSS.
conclusionsThe small sample size limits the ability to conclude whether dFSS performs better as a second-line test of foetal well-being in labour than FBS. A clinician preference for dFSS was apparent, even though robust evidence is lacking.
trial registrationThis trial was prospectively registered on ClinicalTrials.gov on the 31st of March 2022. CLINICALTRIALS: gov Identifier: NCT05306756 (Access at https://clinicaltrials.gov/study/NCT05306756?cond=fetal%20blood%20sampling&rank=3).
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