Lifting the Impacted Fetal Head; the Fetal Pillow and Tydeman Tube Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fetal Pillow, Tydeman Tube.
- Who it may be relevant to
- Registry conditions: Impacted Fetal Head, Full Dilatation Caesarean Section. Basic parameters: from 16 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
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 eleva - 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 upward
Primary outcome measures
- Time from uterine incision to delivery [Time frame: 4 weeks]
Secondary outcome measures (12)
- Uterine incision to closure time [Time frame: 4 weeks]
- Estimated blood loss [Time frame: 4 weeks]
- Requirement of blood products [Time frame: 4 weeks]
- Volume of blood products [Time frame: 4 weeks]
- Presence of uterine angle extensions [Time frame: 4 weeks]
- Presence of visceral injury [Time frame: 4 weeks]
- Need for hysterectomy [Time frame: 4 weeks]
- Presence of genital tract trauma [Time frame: 4 weeks]
- Admission to HDU/ITU [Time frame: 4 weeks]
- Maternal death [Time frame: 4 weeks]
- Length of stay [Time frame: 4 weeks]
- Wound infection [Time frame: 4 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- van der Krogt L, Rosen O'Sullivan H, Hall M, Seed PT, Briley A, Tydeman G, Shennan A. LIFT: Lifting the Impacted fetal head; the Fetal Pillow(R) and Tydeman(R) Tube trial: protocol for a prospective observational study to evaluate two disimpaction devices. BMC Pregnancy Childbirth. 2026 Jun 12. doi: 10.1186/s12884-026-09191-1. Online ahead of print. PMID 42286533
Identifiers
NCT: NCT07372768 · TCF 190908