Fetal Scalp Stimulation Versus Fetal Blood Sampling in Labour (FIRSST)

February 15, 2024 updated by: Deirdre J Murphy, University of Dublin, Trinity College

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Deirdre J Murphy, MD
  • Phone Number: 01 4085200
  • Email: murphyd4@tcd.ie

Study Contact Backup

  • Name: Yulia Shahabuddin, MRCOG
  • Phone Number: 01 4085200
  • Email: yshahabu@tcd.ie

Study Locations

  • Ireland
      • Dublin, Ireland, D8
        • Coombe Women & Infants University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Nulliparous women
  • Singleton pregnancy
  • Cephalic presentation
  • Gestational age 37+0 weeks or greater
  • Abnormal CTG that requires second-line testing (FBS or dFSS)

Exclusion Criteria:

  • Contraindication to FBS
  • Limited understanding of English
  • At the discretion of the responsible obstetrician in cases where there is urgency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Diagnostic test: 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.
Active Comparator: 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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Caesarean section (CS)
Time Frame: at birth
All caesarean sections will be in labour in the context of an abnormal CTG
at birth

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Caesarean section , primary indication fetal concerns
Time Frame: at birth
abnormal CTG, or meconium, or low pH on FBS
at birth
Caesarean section, primary indication poor progress
Time Frame: at birth
Poor progress in first or second stage of labour
at birth
Caesarean section, failed attempt at assisted vaginal birth
Time Frame: at birth
Failed vacuum or forceps in second stage of labour
at birth
Assisted vaginal birth (AVB) (all cases)
Time Frame: at birth
Vacuum or forceps or sequential (vacuum and forceps)
at birth
Assisted vaginal birth, primary indication fetal concerns
Time Frame: at birth
abnormal CTG, or meconium, or low pH on FBS
at birth
Assisted vaginal birth, primary indication poor progress
Time Frame: at birth
Poor progress in second stage of labour
at birth
Spontaneous Vaginal Birth (SVB)
Time Frame: at birth
unassisted birth
at birth
Decision Delivery Interval (DDI) for emergency CS >30 minutes
Time Frame: during labour up until time of birth
Decision delivery interval prolonged
during labour up until time of birth
Decision Delivery Interval (DDI) for AVB >15 minutes
Time Frame: during labour up until time of birth
Decision delivery interval prolonged
during labour up until time of birth
Perinatal death
Time Frame: up to 7 days of age
intrapartum or early neonatal death
up to 7 days of age
Late perinatal death
Time Frame: 8-28 days of life
after 7 days up to 28 days of age
8-28 days of life
Apgar score at 5 minutes <7
Time Frame: age 5 minutes
low Apgar score at 5 minutes
age 5 minutes
pH umbilical artery <7.00 or Base Excess artery <-12.0
Time Frame: immediately after birth
arterial cord blood acidosis
immediately after birth
Admission to neonatal unit (NNU)
Time Frame: from birth up until 28 days
admission all causes
from birth up until 28 days
Neonatal encephalopathy (as defined by authors)
Time Frame: from birth up until 28 days
protocol definition
from birth up until 28 days
Therapeutic hypothermia
Time Frame: indicated within 6 hours of birth
treatment for encephalopathy
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
clinical assessment recording abnormal findings - tone, reflexes, gag
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
traumatic injury or abnormal bleeding
at birth or with first 7 days of life
Major obstetric haemorrhage >1000mL
Time Frame: up to 24 hours after birth
postpartum haemorrhage
up to 24 hours after birth
Obstetric Anal Sphincter Injury (OASI - all degrees)
Time Frame: at birth
injury either spontaneous or with episiotomy
at birth
Referral to perinatal mental health services
Time Frame: from birth up to six weeks after birth
psychological symptoms warranting referral
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
acceptability
from birth up to 7 days after birth
Number of second-line tests (dFSS or FBS)
Time Frame: during labour up until birth
each event (rather than samples taken)
during labour up until birth
Number of inconclusive/uninterpretable dFSS procedures
Time Frame: during labour up until birth
no clear acceleration or variability borderline
during labour up until birth
Number of failed FBS procedures
Time Frame: during labour up until birth
no sample or reliable result achieved
during labour up until birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Dublin, Trinity College

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National University of Ireland, Galway, Ireland
Royal College of Surgeons, Ireland
University of Limerick
University College Cork
Health Research Board, Ireland
Health Research Board - Trials Methodology Research Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Deirdre J Murphy, MD, Trinity College, University of Dublin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DIFA019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Subject to request to PI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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