NCT05306756: FIRSST

Fetal Scalp Stimulation Versus Fetal Blood Sampling in Labour

Terminated NA Last updated 20 February 2024

What this trial tests

NA trial testing Fetal Blood Sampling (FBS) in Intrapartum Fetal Distress in 40 participants. Terminated before completion.

Timeline

10 May 2022

Primary endpoint
1 May 2023

31 August 2023

Quick facts

Lead sponsor	University of Dublin, Trinity College
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	diagnostic
Enrollment	40
Start date	10 May 2022
Primary completion	1 May 2023
Estimated completion	31 August 2023
Sites	1 location across Ireland

Drugs / interventions tested

• Fetal Blood Sampling (FBS)
• digital Fetal Scalp Stimulation (dFSS)

Conditions studied

• Intrapartum Fetal Distress — all drugs for Intrapartum Fetal Distress →

Sponsor

University of Dublin, Trinity College

Who can join

18 and older, female only, with Intrapartum Fetal Distress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pregnant women have routine monitoring of the baby's heart rate when in labour. Women with complicated pregnancies require continuous monitoring using an electronic recorder called a CTG. The CTG produces a paper based recording which is interpreted by the midwife as showing normal, suspicious or abnormal features of the baby's heart rate. Babies quite commonly demonstrate abnormal features from time to time during the course of labour. In some cases the abnormal features are of sufficient concern to warrant delivery by emergency caesarean section. In most of these cases the baby is born in good condition and the question arises whether the caesarean section was unnecessary. In order to reduce the chance of an unnecessary caesarean section additional "second-line" tests can be offered. One such test is where a small drop of blood is taken from the baby's scalp. This test involves an internal examination with an instrument to visualise the baby's head and a small scratch to the baby's scalp. The blood is tested for acid which is an indicator of whether or not the baby is receiving enough oxygen. The test is called a fetal blood sample or FBS. An alternative test is where the doctor or midwife performs a vaginal examination with two fingers and gently rubs the baby's scalp in an attempt to cause an increase in the baby's heart rate. This is a healthy response suggesting that the baby is receiving enough oxygen. The test is called digital fetal scalp stimulation or dFSS. These two "second-line" tests have never been compared in a properly conducted head-to-head comparison. This study aims to compare dFSS and FBS in a large clinical trial completed within four of Ireland's largest maternity hospitals. This trial will generate important evidence of direct relevance to clinical care and patient outcomes.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fetal scalp stimulation for assessing fetal well-being during labour.
   Murphy DJ, Devane D, Molloy E, Shahabuddin Y. · · 2023 · cited 4× · PMID 36625680 · DOI 10.1002/14651858.cd013808.pub2
2. 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).
   Murphy DJ, Shahabuddin Y, Yambasu S, O'Donoghue K, et al · · 2022 · cited 4× · PMID 36195894 · DOI 10.1186/s13063-022-06794-9
3. Digital Foetal Scalp Stimulation Versus Foetal Blood Sampling to Assess Foetal Well-Being in Labour: A Multicentre Randomised Controlled Trial.
   Yambasu S, Boland F, O'Donoghue K, Curran C, et al · · 2025 · cited 1× · PMID 39780658 · DOI 10.1111/1471-0528.18068