Lifting the Impacted Fetal Head; the Fetal Pillow and Tydeman Tube Trial

Summary

A single centre prospective observational comparison trial to compare the Tydeman Tube and Fetal Pillow, to aid delivery of the impacted fetal head at full dilatation caesarean section, and to evaluate the use of the Tydeman Tube at 7-9cm.

Conditions

• Impacted Fetal Head
• Full Dilatation Caesarean Section

Interventions

DEVICE

Fetal Pillow

The Fetal Pillow is a CE marked single use sterile device. It is used in Caesarean sections performed at full dilatation. The Fetal Pillow is designed to atraumatically elevate the fetal head out of the pelvis before a caesarean section begins, making the delivery safer, easier and less traumatic. It comprises of a base plate, which is placed posteriorly in the vagina between the fetal head and the vaginal wall. It is then slowly inflated with 180mls of water via a thin tube, which aims to elevate the fetal head. It is removed at the end of the caesarean section. Some evidence for the Fetal Pillow suggests it can reduce maternal and fetal complications from FDCS by enabling elevation of a deeply engaged head, with some studies demonstrating a reduction in uterine incision extensions, lower estimated blood lossand fewer neonatal intensinve care (NICU)admissions. However evidence is conflicting and newer randomised control trials suggest no difference in outcome when using the device.

DEVICE

Tydeman Tube

The Tydeman Tube is a UKCA/CE marked single use sterile device designed to aid delivery of an impacted fetal head at caesarean section. It consists of a semi-rigid wide bore silicone tube and flexible silicone cup.The tube is inserted into the vagina before or during caesarean section where an impacted fetal head is anticipated or encountered. It can be used from 7-10cm dilated. The cup fits against the baby's head. The tube is held by the assistant and used to elevate the head by pushing upwards. This disimpacts the head from the pelvis and brings it towards the surgeon's hand to enable delivery. The cup dissipates the force applied evenly over a wide area of the head which is intended to prevent fetal trauma. Once the surgeon has gained access below the head, the wide bore tube and design of the cup allows air to enter below the head during delivery to limit suction effect. Once the baby is delivered the Tydeman Tube is removed from the vagina.

Sponsors & Collaborators

• King's College London

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  lead OTHER

Principal Investigators

• Andrew Shennan, MD · King's College London / Guy's and St Thomas'

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

16 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-31

Primary Completion

2027-02-28

Completion

2027-04-30