Evidence map›Paper›PMID 36195894›Full record

Trial reportTrials2022

Digital fetal scalp stimulation (dFSS) versus fetal blood sampling (FBS) to assess fetal wellbeing in labour-a multi-centre randomised controlled trial: Fetal Intrapartum Randomised Scalp Stimulation Trial (FIRSST NCT05306756).

D J Murphy, Y Shahabuddin, S Yambasu, K O'Donoghue, D Devane, A Cotter, G Gaffney, L A Burke, E J Molloy, F Boland

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT05306756 naterminatednot on this map

Fetal Scalp Stimulation (FSS) Versus Fetal Blood Sampling (FBS) to Assess Fetal Wellbeing in Labour - a Multi-centre Randomised Controlled Trial.

TypeinterventionalSponsorUniversity of Dublin, Trinity CollegeRan2022 to 2023Enrolled40ConditionsIntrapartum Fetal DistressArmsFetal Blood Sampling (FBS), digital Fetal Scalp Stimulation (dFSS)
NCT07035028 narecruitingnot on this mapstarted 2024, after this paper: background citation

Evaluation of Fetal Response to Intrapartum Digital Fetal Scalp Stimulation Upon Detection of Suspected Loss of Fetal Well-being in Suspicious and Pathologic Cardiotocographic Recordings, to Identify Intrapartum Fetal Hypoxia.

TypeinterventionalSponsorInstituto de Investigación Sanitaria de la Fundación Jiménez DíazRan2024 to 2025Enrolled182ConditionsFetal Hypoxia, Fetal MonitoringArmsDigital fetal scalp stimulation dFSS
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Fetal scalp stimulation for assessing fetal well-being during labour.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Trial
  3. Tools or culture? Human factors, not technology, drive cesarean section rates for suspected fetal distress.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 1 country.

D J MurphyAcademic Department of Obstetrics and Gynaecology, Coombe Women & Infants University Hospital & Trinity College, University of Dublin, Dublin, Ireland. murphyd4@tcd.ie.ORCID http://orcid.org/0000-0001-6074-6718
Y ShahabuddinAcademic Department of Obstetrics and Gynaecology, Coombe Women & Infants University Hospital & Trinity College, University of Dublin, Dublin, Ireland.
S YambasuAcademic Department of Obstetrics and Gynaecology, Coombe Women & Infants University Hospital & Trinity College, University of Dublin, Dublin, Ireland.
K O'DonoghuePregnancy Loss Research Group, Department of Obstetrics & Gynecology, University College Cork, Cork, Ireland.
D DevaneUniversity of Galway, School of Nursing and Midwifery, HRB-Trials Methodology Research Network, Evidence Synthesis Ireland and Cochrane Ireland, Galway, Ireland.
A CotterDepartment of Obstetrics and Gynecology, University of Limerick, Limerick, Ireland.
G GaffneyDepartment of Obstetrics and Gynaecology, University of Galway, Galway, Ireland.
L A BurkeDepartment of Economics, Cork University Business School, University College Cork, Cork, Ireland.
E J MolloyDepartment of Paediatrics, Trinity College Dublin, Dublin, Ireland.
F BolandData Science Centre and the Department of General Practice, RCSI, Dublin, Ireland.
Trinity College Dublin · IEUniversity College Cork · IEOllscoil na Gaillimhe – University of Galway · IETrials Methodology Research Network · IEUniversity of Limerick · IE

Funding

Health Research Board DIFA-FA-019
6 · The paper itself

Abstract

backgroundCardiotocography (CTG) is a screening test used to detect fetal hypoxia in labour. It has a high false positive rate resulting in many potentially unnecessary caesarean sections. Fetal blood sampling (FBS) is a second-line test of the acid-base status of the fetus. It is used to provide either reassurance that it is safe for labour to continue or objective evidence of compromise so that delivery can be expedited. Digital fetal scalp stimulation (dFSS) to elicit a fetal heart rate acceleration is an alternative less invasive second-line test of fetal wellbeing. This study aims to provide robust evidence on the role of these two second-line tests in assessing fetal wellbeing and potentially preventing operative delivery.

methodsA multi-centre parallel group randomised controlled trial (RCT) is planned in four maternity centres in Ireland. The study aims to recruit 2500 nulliparous women with a term (≥37+0 weeks) singleton pregnancy who require a second-line test of fetal wellbeing in labour due to an abnormal CTG. Women will be allocated randomly to dFSS or FBS on a 1:1 ratio. The primary outcome is caesarean section. With 1250 women in each arm, the study will have 90% power to detect a difference of 5-6%, at a two-sided alpha significance level of 5%, assuming a caesarean section rate of at least 20% in the dFSS group. DISCUSSION: If the proposed study shows evidence that dFSS is a safe, reliable and effective alternative to FBS, this would have ground-breaking implications for labour management worldwide. It could potentially lead to a reduction in invasive procedures and emergency caesarean sections.

trial registrationClinicalTrials.gov NCT05306756. Registered on 31 March 2022. The trial commenced enrolment on 10 May 2022. Ethical committee approval has been granted by the Research Ethics Committee (REC) of each hospital: Dublin/CWIUH REC: 12.06.2019; Cork/UCC REC: 29.11.2019; Galway/NUIG REC: 06.09.2019; Limerick/UL REC: 30.09.2019.

Indexed as

Labor, ObstetricScalpCardiotocographyFemaleFetal BloodHeart Rate, FetalHumansPregnancyCaesarean sectionCardiotocographyDigital fetal scalp stimulation (dFSS)Fetal blood sampling (FBS)LabourRandomised controlled trial

Identifiers

PMID36195894
PMCPMC9531493
OpenAlexW4301395961

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.