Lifting the Impacted Fetal Head; the Fetal Pillow and Tydeman Tube Trial (LIFT)

Guy's and St Thomas' NHS Foundation Trust

Status: Not yet enrolling

Conditions: Impacted Fetal Head; Full Dilatation Caesarean Section

Treatments: Device: Fetal Pillow; Device: Tydeman Tube

Study type: Interventional

Funder types: Other

Identifiers

NCT07372768

TCF 190908

Details and patient eligibility

About

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.

Full description

An impacted fetal head is a common complication encountered in 11% of all emergency caesarean sections and 65% of those performed at full dilatation. A recent UK Obstetric Surveillance Survey (UKOSS) highlighted significant maternal and neonatal complications secondary to an impacted fetal head, with 3% of babies dying or suffering a severe injury, and 6.1% of mother's requiring admission to intensive care, emphasizing the need to evaluate techniques and new devices to aid delivery. NHS resolution's early notification scheme implicated an impacted fetal head as a contributing factor in 9% of all severe neonatal brain injuries in 2019. There is no consensus amongst clinicians on the best management of an impacted fetal head, and with exponentially rising rates of intrapartum caesarean sections, improved management tools are urgently required.

This study will compare maternal and neonatal outcomes using two devices to aid delivery of an impacted fetal head at full dilatation caesarean section (FDCS)- the Tydeman Tube, a new UK Conformity Assessed (UKCA) and European Conformity (CE) marked device, and the Fetal Pillow, an existing CE marked device used commonly in clinical practice. There will be a separate observational sub study evaluating the use of the Tydeman Tube for managing an impacted fetal head at 7-9cm dilated. The study will also explore the acceptability of both devices to women and clinicians using postnatal questionnaires.

Participants will be all women requiring a full dilatation caesarean section who meet eligibility criteria. The study will be run in two consecutive arms - firstly, obstetricians and midwives will be trained to use the Fetal Pillow. The Fetal Pillow will then be introduced into clinical practice for 3-6 months. Following this the Fetal Pillow will be removed from clinical practice. Midwives and Obstetricians will then be trained to use the Tydeman Tube, which will be introduced into clinical practice for a further 3-6 months. During the Tydeman Tube arm of the trial, women undergoing caesarean section at 7-9cm who are found to have an impacted fetal head unexpectedly at the time of caesarean section are eligible for the observational sub study. If the operating surgeon believes the Tydeman Tube is required for the clinical situation then it may be used.

The trial is a prospective observational comparison trial with an additional observational sub study. The results of this study will be used to improve understanding on the best management techniques for an impacted fetal head.

Enrollment: 80 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Fetal Pillow

Active Comparator group

Description:

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.

Treatment:

Device: Fetal Pillow

Tydeman Tube

Active Comparator group

Description:

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.

Treatment:

Device: Tydeman Tube