Impacted Fetal HeadLIFTNCT07372768
Lifting the Impacted Fetal Head; the Fetal Pillow and Tydeman Tube Trial
A study testing Fetal Pillow and Tydeman Tube in people with Impacted Fetal Head and Full Dilatation Caesarean Section, run by Guy's and St Thomas' NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Impacted Fetal Head, Full Dilatation Caesarean Section
- What is being tested?
- Fetal Pillow and Tydeman Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Cervical dilatation <10cm for fetal pillow arm and <7cm for tydeman tube arm
- Gestational age <37 weeks
- non-cephalic presentation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Andrew Shennan, MD contact
About this study
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.
Read the 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.
- Being tested
- Fetal Pillow, Tydeman Tube
- Keywords
- Impacted fetal head, Caesarean section, Full dilatation caesarean section, Tydeman Tube, Fetal Pillow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal PillowDevice
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.
Tydeman TubeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Tydeman Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from uterine incision to delivery
Seconds
Measured: 4 weeks
Secondary outcomes (25)
Uterine incision to closure time
Seconds
Measured: 4 weeks
Estimated blood loss
mLs
Measured: 4 weeks
Requirement of blood products
Yes/No
Measured: 4 weeks
Volume of blood products
Dependent on type of product
Measured: 4 weeks
Presence of uterine angle extensions
Yes/No
Measured: 4 weeks
Presence of visceral injury
Yes/No - visceral injuries may include ureter, cervix, bladder, bowel
Measured: 4 weeks
Need for hysterectomy
Yes/No
Measured: 4 weeks
Presence of genital tract trauma
Yes/No - genital tract trauma may include lacerations and haematomas
Measured: 4 weeks
Admission to HDU/ITU
Yes/No
Measured: 4 weeks
Maternal death
Yes/No
Measured: 4 weeks
Length of stay
Days
Measured: 4 weeks
Wound infection
Yes/No
Measured: 4 weeks
Endometritis
Yes/No
Measured: 4 weeks
Change in maternal haemoglobin (Hb)
Difference in measured Hb before caesarean and after caesarean
Measured: 4 weeks
Presence of birth trauma to the neonate
Yes/No - birth trauma may include intracranial haemorrhage, skull fracture, other fracture, facial nerve injury (bruising/facial nerve palsy/other nerve injury)
Measured: 4 weeks
Apgar score
Routine test taken of the newborn infant based on Appearance (colour), Pulse (heart rate), Grimace (reflexes), Activity (muscle tone) and Respiration (breathing) at 5 and 10 minutes - scored from 0-10 with lower scores indicating poor condition and need for assessment/intervention
Measured: 4 weeks
Resuscitation required
Yes/No
Measured: 4 weeks
Admission to special care baby unit (SCBU) or neonatal intensive care unit (NICU)
Yes/No
Measured: 4 weeks
Length of stay in higher care
Days
Measured: 4 weeks
Arterial cord pH measurement
Measures the acidity of a newborn's blood from the umbilical artery, reflecting fetal oxygenation and metabolic state at birth, with normal ranges around 7.18-7.38, lower values (<7.0) can signal distress, risk of neurological issues and often require neonatal observation
Measured: 4 weeks
Diagnosis of hypoxic-ischaemic encephalopathy (HIE)
Yes/No and Grading (1,2,3)
HIE is a brain injury from lack of oxygen and/or blood flow to the brain around the time of birth, affecting newborns. It is associated with potential long-term disability including cerebral palsy or developmental delay, and in severe cases death. Symptoms include seizures, poor feeding and altered alternates. It is graded as mild (Grade 1), moderate (Grade 2) and severe (Grade 3)
Measured: 4 weeks
Perinatal death
Yes/No
Measured: 4 weeks
Neonatal feeding
Measured: 4 weeks
Evaluation of Fetal Pillow / Tydeman tube using Lickert scale questionnaires (clinician)
Acceptability, ease of use, perception of impacted head and perception of ease of delivery will be assessed using Lickert scale questionnaires where participants will be asked to rate their level of agreement or feeling on a symmetrical scale, form one extreme to another (i.e. 'strongly disagree' to 'strongly agree')
Measured: 4 weeks
Acceptability of Fetal Pillow / Tydeman Tube using Lickert scan questionnaires (maternal)
Patients perception of the acceptability of the two devices will be assessed using Lickert scale questionnaires where participants will be asked to rate their level of agreement or feeling on a symmetrical scale, form one extreme to another (i.e. 'strongly disagree' to 'strongly agree')
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impacted Fetal HeadStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Sequential arms with 2 different treatments. 3-6 months using first device (Fetal Pillow), 3-6 months using second device (Tydeman Tube).
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Andrew Shennan, MD, Principal investigator, King's College London / Guy's and St Thomas'
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372768
- Sponsor's protocol ID
- TCF 190908
- Acronym
- LIFT
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 42286533
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifting the Impacted Fetal Head; the Fetal Pillow and Tydeman Tube Trial
- ClinicalTrials.gov ID
- NCT07372768
- Acronym / sponsor ID
- LIFT / TCF 190908
- Keywords
- Impacted fetal head, Caesarean section, Full dilatation caesarean section, Tydeman Tube, Fetal Pillow
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Jan 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequential arms with 2 different treatments. 3-6 months using first device (Fetal Pillow), 3-6 months using second device (Tydeman Tube).
| Arm | Type | Receives |
|---|---|---|
| Fetal Pillow | Active comparator | Device: Fetal PillowThe Fetal Pillow will be used for women undergoing full dilatation caesarean section who meet eligibillity criteria during the recruitment period of 3-6 months. |
| Tydeman Tube | Active comparator | Device: Tydeman TubeThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Allergy to silicone rubber
- Major congenital abnormalities
- Major anomaly of the fetal head (i.e. large encephalocele)
- Intrauterine death
- Suspected chorioamnionitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal PillowThe 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 | Fetal Pillow |
| Tydeman TubeThe 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. | Device | Tydeman Tube |
Primary outcome
Time from uterine incision to delivery
Time frame: 4 weeks
Seconds
25 secondary outcomes
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
Endometritis
Time frame: 4 weeks
Change in maternal haemoglobin (Hb)
Time frame: 4 weeks
Presence of birth trauma to the neonate
Time frame: 4 weeks
Apgar score
Time frame: 4 weeks
Resuscitation required
Time frame: 4 weeks
Admission to special care baby unit (SCBU) or neonatal intensive care unit (NICU)
Time frame: 4 weeks
Length of stay in higher care
Time frame: 4 weeks
Arterial cord pH measurement
Time frame: 4 weeks
Diagnosis of hypoxic-ischaemic encephalopathy (HIE)
Time frame: 4 weeks
Perinatal death
Time frame: 4 weeks
Neonatal feeding
Time frame: 4 weeks
Evaluation of Fetal Pillow / Tydeman tube using Lickert scale questionnaires (clinician)
Time frame: 4 weeks
Acceptability of Fetal Pillow / Tydeman Tube using Lickert scan questionnaires (maternal)
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Derived from this study: PubMed 42286533van 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Shennan, MD contact
Andrew Shennan, MD principal investigator
King's College London / Guy's and St Thomas'
Questions about this trial
What is this clinical trial studying?
A study testing Fetal Pillow and Tydeman Tube in people with Impacted Fetal Head and Full Dilatation Caesarean Section, run by Guy's and St Thomas' NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura van der Krogt, MBBS (+4420 7836 5454., laura.c.van_der_krogt@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from uterine incision to delivery (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07372768, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.