Abstract title: Digital Fetal scalp stimulation (dFSS) versus Fetal blood sampling (FBS) for women with abnormal fetal heart rate monitoring in labour: a multicentre non-inferiority randomised controlled trial.
Background: Fetal heart rate monitoring in labour is often abnormal which can result in the decision to deliver by caesarean section. Fetal blood sampling (FBS) is an invasive second line test of fetal wellbeing that provides either reassurance that labour can continue or confirmation that delivery should be expedited. Fetal scalp stimulation by digital massage (dFSS) is an alternative non-invasive second line test but has not been compared definitively with FBS.
Objective: To evaluate the effectiveness of dFSS as a second line test of fetal wellbeing in labour compared to FBS.
Design: Multi-centre non-infertiority randomised controlled trial.
Setting: Five maternity centres in Ireland.
Intended sample: 3000 women requiring a second line test of fetal wellbeing as a result of abnormal fetal cardiotocography.
Methods: Participants will be randomly allocated to dFSS or FBS. A transition phase will be conducted in each centre as a preliminary approach to increase awareness and confidence in dFSS before the randomisation phase commences.
Main outcome measures: The primary outcome is caesarean section in labour. Secondary maternal outcomes include operative vaginal delivery, postpartum haemorrhage, prolonged hospital stay and maternal satisfaction. Secondary perinatal outcomes include low Apgar scores, fetal acidosis, neonatal admission to the intensive care unit and encephalopathy requiring therapeutic hypothermia. Procedural outcomes include number of second line tests performed, number of reviews by obstetric staff and incidence of fetal blood sampling in the dFSS group. A cost-effectiveness analysis will be completed.
Implications: If the proposed study confirmed dFSS to be a reliable and effective alternative to FBS this would have ground breaking implications for the management of labour worldwide.
