Intrapartum Fetal DistressFIRSSTNCT05306756
Fetal Scalp Stimulation Versus Fetal Blood Sampling in Labour
A study testing Fetal Blood Sampling (FBS) and digital Fetal Scalp Stimulation (dFSS) in people with Intrapartum Fetal Distress, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intrapartum Fetal Distress
- What is being tested?
- Fetal Blood Sampling (FBS) and digital Fetal Scalp Stimulation (dFSS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- 10 May 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nulliparous women
- Singleton pregnancy
- Cephalic presentation
- Gestational age 37+0 weeks or greater
- Abnormal CTG that requires second-line testing (FBS or dFSS)
Who cannot join
- Contraindication to FBS
- Limited understanding of English
- At the discretion of the responsible obstetrician in cases where there is urgency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fetal Scalp Stimulation (FSS) Versus Fetal Blood Sampling (FBS) to Assess Fetal Wellbeing in Labour - a Multi-centre Randomised Controlled Trial.
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.
Read the detailed description
Continuous electronic fetal heart rate recording with cardiotocography (CTG) is a standard approach to monitoring fetal wellbeing in labour and is recommended for high-risk pregnancies. The aim is to identify fetal compromise early and intervene in order to reduce serious adverse events such as cerebral palsy and perinatal death. CTG abnormalities are relatively common and can lead to the decision to deliver by emergency caesarean section. In most cases the fetus is subsequently found to have been compensating for the stress of labour and is not actually compromised. Fetal blood sampling (FBS) is a second-line invasive test that provides information on the acid-base status of the fetus, reflecting hypoxia. It is used to provide either reassurance that labour can continue, or more objective evidence that delivery needs to be expedited. Clinical guidelines in the United Kingdom and Ireland have treated FBS as a gold standard test. Recent studies have questioned the validity and reliability of FBS, and also the logistic challenges of achieving a result in a timely manner. Fetal scalp stimulation (dFSS) by digital rubbing is an alternative less invasive test of fetal wellbeing in labour and is recommended in preference to FBS in US guidelines. This research aims to compare digital FSS and FBS in women with term singleton pregnancies and an abnormal intrapartum CTG, where additional information on fetal wellbeing is required. A multi-centre randomised controlled trial will be conducted. The clinical outcomes of interest will include caesarean section, assisted vaginal birth, low Apgar scores, cord blood acidosis, and admission to the neonatal unit. This trial will generate important evidence of direct relevance to clinical care and patient outcomes.
- Conditions
- Intrapartum Fetal Distress
- Being tested
- Fetal Blood Sampling (FBS), digital Fetal Scalp Stimulation (dFSS)
- Keywords
- randomised controlled trial, fetal blood sampling, fetal scalp stimulation, cardiotocography, caesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Blood Sampling (FBS)Diagnostic test
Vaginal examination, insert amnioscope through cervix, visualise fetal scalp, clean fetal scalp, apply ethyl chloride spray, wipe scalp with petroleum gel, small scalp scratch with sharp instrument, collect sample in heparinised capillary tube, analyse sample.
digital Fetal Scalp Stimulation (dFSS)Diagnostic test
Vaginal examination, insert one or two fingers through cervix onto fetal scalp, rub fetal scalp digitally for approximately 30-60 seconds, withdraw fingers and observe CTG for 5-10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Fetal Blood Sampling (FBS) | Active comparator | Fetal capillary blood samples will be collected in heparinised tubes and analysed in the delivery suite using the locally available gas analyser. The result of the first technically reliable sample, or the lowest reliable sample if multiple samples are tested, will be interpreted and acted upon according to the protocol, taking account of the clinical circumstances and the stage of labour:
pH ≥7.25 normal, continue and if indicated repeat in 60 minutes; pH 7.21-7.24 borderline, repeat in 30 minutes; pH ≤ 7.20 abnormal, deliver. Receives: Diagnostic Test: Fetal Blood Sampling (FBS) |
| digital Fetal Scalp Stimulation (dFSS) | Active comparator | The examiner will stimulate the fetal scalp digitally with the index and middle finger over a period of 30-60 seconds.The CTG will be observed over a 5-10 minutes interval after the dFSS and if a fetal heart rate acceleration (>15 bpm for 15 seconds) is observed the test will be considered normal. If there is an episode of normal variability (5-25 bpm) but there is no clear acceleration, the test will be considered borderline. If there is no FHR acceleration and no episode of normal variability with ongoing abnormal features, the test should be interpreted as abnormal in the same way as an abnormal FBS result.
FHR acceleration normal, if indicated repeat in 60 min; Uncertain acceleration/ normal variability borderline, repeat in 30 minutes; No Acceleration/ongoing abnormal features abnormal, deliver. Receives: Diagnostic Test: digital Fetal Scalp Stimulation (dFSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caesarean section (CS)
All caesarean sections will be in labour in the context of an abnormal CTG
Measured: at birth
Secondary outcomes (25)
Caesarean section , primary indication fetal concerns
abnormal CTG, or meconium, or low pH on FBS
Measured: at birth
Caesarean section, primary indication poor progress
Poor progress in first or second stage of labour
Measured: at birth
Caesarean section, failed attempt at assisted vaginal birth
Failed vacuum or forceps in second stage of labour
Measured: at birth
Assisted vaginal birth (AVB) (all cases)
Vacuum or forceps or sequential (vacuum and forceps)
Measured: at birth
Assisted vaginal birth, primary indication fetal concerns
abnormal CTG, or meconium, or low pH on FBS
Measured: at birth
Assisted vaginal birth, primary indication poor progress
Poor progress in second stage of labour
Measured: at birth
Spontaneous Vaginal Birth (SVB)
unassisted birth
Measured: at birth
Decision Delivery Interval (DDI) for emergency CS >30 minutes
Decision delivery interval prolonged
Measured: during labour up until time of birth
Decision Delivery Interval (DDI) for AVB >15 minutes
Decision delivery interval prolonged
Measured: during labour up until time of birth
Perinatal death
intrapartum or early neonatal death
Measured: up to 7 days of age
Late perinatal death
after 7 days up to 28 days of age
Measured: 8-28 days of life
Apgar score at 5 minutes <7
low Apgar score at 5 minutes
Measured: age 5 minutes
pH umbilical artery <7.00 or Base Excess artery <-12.0
arterial cord blood acidosis
Measured: immediately after birth
Admission to neonatal unit (NNU)
admission all causes
Measured: from birth up until 28 days
Neonatal encephalopathy (as defined by authors)
protocol definition
Measured: from birth up until 28 days
Therapeutic hypothermia
treatment for encephalopathy
Measured: indicated within 6 hours of birth
Abnormal neurological examination prior to discharge
clinical assessment recording abnormal findings - tone, reflexes, gag
Measured: at time of hospital discharge, assessed up to 28 days after birth
FBS related injury/complication to baby (as reported on neonatal examination)
traumatic injury or abnormal bleeding
Measured: at birth or with first 7 days of life
Major obstetric haemorrhage >1000mL
postpartum haemorrhage
Measured: up to 24 hours after birth
Obstetric Anal Sphincter Injury (OASI - all degrees)
injury either spontaneous or with episiotomy
Measured: at birth
Referral to perinatal mental health services
psychological symptoms warranting referral
Measured: from birth up to six weeks after birth
Maternal acceptability of procedure (defined by questionnaire)
acceptability
Measured: from birth up to 7 days after birth
Number of second-line tests (dFSS or FBS)
each event (rather than samples taken)
Measured: during labour up until birth
Number of inconclusive/uninterpretable dFSS procedures
no clear acceleration or variability borderline
Measured: during labour up until birth
Number of failed FBS procedures
no sample or reliable result achieved
Measured: during labour up until birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start10 May 2022
- Primary completion1 May 2023
- Study completion31 Aug 2023
Why it stopped: Insufficient randomizations due to changes in clinical practice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intrapartum Fetal DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients in labor with CTG abnormalities that warrant second-line testing of fetal wellbeing - randomized to digital fetal scalp stimulation (dFSS) versus fetal blood sampling (FBS)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- University College Cork, University of Limerick, Royal College of Surgeons, Ireland, National University of Ireland, Galway, Ireland, Health Research Board, Ireland, Health Research Board - Trials Methodology Research Network
- Responsible party
- Principal investigator, Deirdre J Murphy, University of Dublin, Trinity College
- Investigators
- Deirdre J Murphy, MD, Principal investigator, Trinity College, University of Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306756
- Sponsor's protocol ID
- DIFA019
- Acronym
- FIRSST
- Status last verified
- Feb 2024
- First submitted
- 14 Mar 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Subject to request to PI
Publications
Hughes O, Murphy DJ. Comparing second-line tests to assess fetal wellbeing in Labor: a feasibility study and pilot randomized controlled trial. J Matern Fetal Neonatal Med. 2022 Jan;35(1):91-99. doi: 10.1080/14767058.2020.1712704. Epub 2020 Jan 12.
PubMed 31928269Yambasu S, Boland F, O'Donoghue K, Curran C, Shahabuddin Y, Cotter A, Gaffney G, Devane D, Molloy EJ, Murphy DJ. Digital Foetal Scalp Stimulation Versus Foetal Blood Sampling to Assess Foetal Well-Being in Labour: A Multicentre Randomised Controlled Trial. BJOG. 2025 Apr;132(5):557-564. doi: 10.1111/1471-0528.18068. Epub 2025 Jan 9.
PubMed 39780658Murphy DJ, Shahabuddin Y, Yambasu S, O'Donoghue K, Devane D, Cotter A, Gaffney G, Burke LA, Molloy EJ, Boland F. 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). Trials. 2022 Oct 4;23(1):848. doi: 10.1186/s13063-022-06794-9.
PubMed 36195894
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Scalp Stimulation (FSS) Versus Fetal Blood Sampling (FBS) to Assess Fetal Wellbeing in Labour - a Multi-centre Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05306756
- Acronym / sponsor ID
- FIRSST / DIFA019
- Conditions
- Intrapartum Fetal Distress
- Keywords
- randomised controlled trial, fetal blood sampling, fetal scalp stimulation, cardiotocography, caesarean section
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient randomizations due to changes in clinical practice
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- University College Cork, University of Limerick, Royal College of Surgeons, Ireland, National University of Ireland, Galway, Ireland, Health Research Board, Ireland, Health Research Board - Trials Methodology Research Network
- Study start
- 10 May 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Continuous electronic fetal heart rate recording with cardiotocography (CTG) is a standard approach to monitoring fetal wellbeing in labour and is recommended for high-risk pregnancies. The aim is to identify fetal compromise early and intervene in order to reduce serious adverse events such as cerebral palsy and perinatal death. CTG abnormalities are relatively common and can lead to the decision to deliver by emergency caesarean section. In most cases the fetus is subsequently found to have been compensating for the stress of labour and is not actually compromised. Fetal blood sampling (FBS) is a second-line invasive test that provides information on the acid-base status of the fetus, reflecting hypoxia. It is used to provide either reassurance that labour can continue, or more objective evidence that delivery needs to be expedited. Clinical guidelines in the United Kingdom and Ireland have treated FBS as a gold standard test. Recent studies have questioned the validity and reliability of FBS, and also the logistic challenges of achieving a result in a timely manner. Fetal scalp stimulation (dFSS) by digital rubbing is an alternative less invasive test of fetal wellbeing in labour and is recommended in preference to FBS in US guidelines. This research aims to compare digital FSS and FBS in women with term singleton pregnancies and an abnormal intrapartum CTG, where additional information on fetal wellbeing is required. A multi-centre randomised controlled trial will be conducted. The clinical outcomes of interest will include caesarean section, assisted vaginal birth, low Apgar scores, cord blood acidosis, and admission to the neonatal unit. This trial will generate important evidence of direct relevance to clinical care and patient outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients in labor with CTG abnormalities that warrant second-line testing of fetal wellbeing - randomized to digital fetal scalp stimulation (dFSS) versus fetal blood sampling (FBS)
| Arm | Type | Receives |
|---|---|---|
| Fetal Blood Sampling (FBS) | Active comparator | Diagnostic Test: Fetal Blood Sampling (FBS)Fetal capillary blood samples will be collected in heparinised tubes and analysed in the delivery suite using the locally available gas analyser. The result of the first technically reliable sample, or the lowest reliable sample if multiple samples are tested, will be interpreted and acted upon according to the protocol, taking account of the clinical circumstances and the stage of labour: pH ≥7.25 normal, continue and if indicated repeat in 60 minutes; pH 7.21-7.24 borderline, repeat in 30 minutes; pH ≤ 7.20 abnormal, deliver. |
| digital Fetal Scalp Stimulation (dFSS) | Active comparator | Diagnostic Test: digital Fetal Scalp Stimulation (dFSS)The examiner will stimulate the fetal scalp digitally with the index and middle finger over a period of 30-60 seconds.The CTG will be observed over a 5-10 minutes interval after the dFSS and if a fetal heart rate acceleration (>15 bpm for 15 seconds) is observed the test will be considered normal. If there is an episode of normal variability (5-25 bpm) but there is no clear acceleration, the test will be considered borderline. If there is no FHR acceleration and no episode of normal variability with ongoing abnormal features, the test should be interpreted as abnormal in the same way as an abnormal FBS result. FHR acceleration normal, if indicated repeat in 60 min; Uncertain acceleration/ normal variability borderline, repeat in 30 minutes; No Acceleration/ongoing abnormal features abnormal, deliver. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Nulliparous women
- Singleton pregnancy
- Cephalic presentation
- Gestational age 37+0 weeks or greater
- Abnormal CTG that requires second-line testing (FBS or dFSS)
Key exclusion criteria (3 listed)
- Contraindication to FBS
- Limited understanding of English
- At the discretion of the responsible obstetrician in cases where there is urgency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal Blood Sampling (FBS)Vaginal examination, insert amnioscope through cervix, visualise fetal scalp, clean fetal scalp, apply ethyl chloride spray, wipe scalp with petroleum gel, small scalp scratch with sharp instrument, collect sample in heparinised capillary tube, analyse sample. | Diagnostic test | Fetal Blood Sampling (FBS) |
| digital Fetal Scalp Stimulation (dFSS)Vaginal examination, insert one or two fingers through cervix onto fetal scalp, rub fetal scalp digitally for approximately 30-60 seconds, withdraw fingers and observe CTG for 5-10 minutes. | Diagnostic test | digital Fetal Scalp Stimulation (dFSS) |
Primary outcome
Caesarean section (CS)
Time frame: at birth
All caesarean sections will be in labour in the context of an abnormal CTG
25 secondary outcomes
Caesarean section , primary indication fetal concerns
Time frame: at birth
Caesarean section, primary indication poor progress
Time frame: at birth
Caesarean section, failed attempt at assisted vaginal birth
Time frame: at birth
Assisted vaginal birth (AVB) (all cases)
Time frame: at birth
Assisted vaginal birth, primary indication fetal concerns
Time frame: at birth
Assisted vaginal birth, primary indication poor progress
Time frame: at birth
Spontaneous Vaginal Birth (SVB)
Time frame: at birth
Decision Delivery Interval (DDI) for emergency CS >30 minutes
Time frame: during labour up until time of birth
Decision Delivery Interval (DDI) for AVB >15 minutes
Time frame: during labour up until time of birth
Perinatal death
Time frame: up to 7 days of age
Late perinatal death
Time frame: 8-28 days of life
Apgar score at 5 minutes <7
Time frame: age 5 minutes
pH umbilical artery <7.00 or Base Excess artery <-12.0
Time frame: immediately after birth
Admission to neonatal unit (NNU)
Time frame: from birth up until 28 days
Neonatal encephalopathy (as defined by authors)
Time frame: from birth up until 28 days
Therapeutic hypothermia
Time frame: indicated within 6 hours of birth
Abnormal neurological examination prior to discharge
Time frame: at time of hospital discharge, assessed up to 28 days after birth
FBS related injury/complication to baby (as reported on neonatal examination)
Time frame: at birth or with first 7 days of life
Major obstetric haemorrhage >1000mL
Time frame: up to 24 hours after birth
Obstetric Anal Sphincter Injury (OASI - all degrees)
Time frame: at birth
Referral to perinatal mental health services
Time frame: from birth up to six weeks after birth
Maternal acceptability of procedure (defined by questionnaire)
Time frame: from birth up to 7 days after birth
Number of second-line tests (dFSS or FBS)
Time frame: during labour up until birth
Number of inconclusive/uninterpretable dFSS procedures
Time frame: during labour up until birth
Number of failed FBS procedures
Time frame: during labour up until birth
Results and safety
The study was stopped early (reason given: Insufficient randomizations due to changes in clinical practice). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 31928269Hughes O, Murphy DJ. Comparing second-line tests to assess fetal wellbeing in Labor: a feasibility study and pilot randomized controlled trial. J Matern Fetal Neonatal Med. 2022 Jan;35(1):91-99. doi: 10.1080/14767058.2020.1712704. Epub 2020 Jan 12.
- Derived from this study: PubMed 39780658Yambasu S, Boland F, O'Donoghue K, Curran C, Shahabuddin Y, Cotter A, Gaffney G, Devane D, Molloy EJ, Murphy DJ. Digital Foetal Scalp Stimulation Versus Foetal Blood Sampling to Assess Foetal Well-Being in Labour: A Multicentre Randomised Controlled Trial. BJOG. 2025 Apr;132(5):557-564. doi: 10.1111/1471-0528.18068. Epub 2025 Jan 9.
- Derived from this study: PubMed 36195894Murphy DJ, Shahabuddin Y, Yambasu S, O'Donoghue K, Devane D, Cotter A, Gaffney G, Burke LA, Molloy EJ, Boland F. 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). Trials. 2022 Oct 4;23(1):848. doi: 10.1186/s13063-022-06794-9.
- Individual participant dataSharing planned: No. Subject to request to PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deirdre J Murphy, MD principal investigator
Trinity College, University of Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal Blood Sampling (FBS) and digital Fetal Scalp Stimulation (dFSS) in people with Intrapartum Fetal Distress, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient randomizations due to changes in clinical practice). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caesarean section (CS) (time frame: at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05306756, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.