LIFT trial
Research type
Research Study
Full title
Lifting the Impacted fetal head; the Fetal Pillow and Tydeman Tube trial
IRAS ID
321718
Contact name
Andrew Shennan
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
This study compares 2 devices - the Fetal Pillow and the Tydeman Tube. Both devices are CE marked and available via the NHS Supply Chain. The Fetal Pillow is routinely used in some UK obstetric units, and the Tydeman Tube is a novel device which is being introduced into clinical practice.
These devices are used to help when there is difficulty delivering a baby’s head during a caesarean section in late labour, known as an impacted fetal head. An impacted fetal head is a common and potentially serious complication which can cause significant harm to mother and baby. There is no current recommendation for how best to manage this complication.
We will use the Fetal Pillow and Tydeman Tube for women requiring a caesarean when their cervix is fully dilated, as this is the most common time when an impacted fetal head occurs. We will use the devices sequentially - the Fetal Pillow for 3-6 months followed by the Tydeman Tube for 3-6 months. We will compare clinical outcomes between each device group, and against a historical cohort.
It is difficult to predict when an impacted fetal head may occur, and this is sometimes before the cervix is fully dilated. We will perform an additional observational sub-study using the Tydeman Tube during caesarean sections when the cervix is 7-9cm dilated and an impacted fetal head is encountered unexpectedly. We will collect clinical outcomes from these participants and compare them with outcomes from a historical cohort with no device used.
As an impacted fetal head is a medical emergency, we will seek consent to collect outcome data from women after their caesarean section, before discharge from hospital. We will ask participants and clinicians to fill in questionnaires regarding acceptability and usability of both devices.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
25/YH/0140
Date of REC Opinion
18 Aug 2025
REC opinion
Further Information Favourable Opinion