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

NCT07372768 | Not Yet Recruiting DMC

• 1 other identifier: TCF 190908
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Full Dilatation Caesarean Section; Impacted Fetal Head

Keywords

Impacted fetal head; Caesarean section; Full dilatation caesarean section; Tydeman Tube; Fetal Pillow

Outcome Measures

Primary Outcomes (1)

• Time from uterine incision to delivery

  Seconds

  4 weeks

Secondary Outcomes (25)

• Uterine incision to closure time

  4 weeks

• Estimated blood loss

  4 weeks

• Requirement of blood products

  4 weeks

• Volume of blood products

  4 weeks

• Presence of uterine angle extensions

  4 weeks

Study Arms (2)

Fetal Pillow

ACTIVE COMPARATOR

The Fetal Pillow will be used for women undergoing full dilatation caesarean section who meet eligibillity criteria during the recruitment period of 3-6 months.

Device: Fetal Pillow

Tydeman Tube

ACTIVE COMPARATOR

The Tydeman tube will be used for women undergoing full dilatation caesarean section who meet eligibility criteria during the recruitment period of 3-6 months. In addition the Tydeman Tube will be used at the discretion of the operating clinician during caesarean sections performed at 7-9cm where an impacted fetal head is encountered unexpectedly.

Device: Tydeman Tube

Interventions

Fetal Pillow DEVICE

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.

Fetal Pillow

Tydeman Tube DEVICE

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.

Tydeman Tube

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing caesarean section at full dilataion for fetal pillow arm, or caesarean section at 7 or more centimetres dilated for the tydeman tube arm
• Singleton pregnancy
• Cephalic presentation

You may not qualify if:

• Allergy to silicone rubber
• Major congenital abnormalities
• Major anomaly of the fetal head (i.e. large encephalocele)
• Intrauterine death
• Suspected chorioamnionitis
• Active genital infection inc. Herpes Simplex Virus
• Cervical dilatation \<10cm for fetal pillow arm and \<7cm for tydeman tube arm
• Gestational age \<37 weeks
• non-cephalic presentation

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Officials

• Andrew Shennan, MD

  King's College London / Guy's and St Thomas'

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura van der Krogt, MBBS

CONTACT

+4420 7836 5454.; laura.c.van_der_krogt@kcl.ac.uk

Andrew Shennan, MD

CONTACT

andrew.shennan@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential arms with 2 different treatments. 3-6 months using first device (Fetal Pillow), 3-6 months using second device (Tydeman Tube).

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 28, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share