Fetal Scalp Stimulation Versus Fetal Blood Sampling in Labour

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. 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.

Conditions

• Intrapartum Fetal Distress

Interventions

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.

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.

Sponsors & Collaborators

• University College Cork

  collaborator OTHER

• University of Limerick

  collaborator OTHER

• Royal College of Surgeons, Ireland

  collaborator OTHER

• National University of Ireland, Galway, Ireland

  collaborator OTHER

• Health Research Board, Ireland

  collaborator OTHER

• Health Research Board - Trials Methodology Research Network

  collaborator OTHER

• University of Dublin, Trinity College

  lead OTHER

Principal Investigators

• Deirdre J Murphy, MD · Trinity College, University of Dublin

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-10

Primary Completion

2023-05-01

Completion

2023-08-31

Countries

• Ireland

Study Locations