New trial tests inflatable pillow vs tube to free stuck baby heads in emergency C-Sections
NCT ID NCT07372768
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two devices—the Fetal Pillow (an inflatable balloon) and the Tydeman Tube (a manual tool)—used to lift a baby's head when it gets stuck during a full-dilatation C-section. Researchers will measure how quickly the baby is delivered and track complications like bleeding or injury. About 80 women with a single baby in head-down position will take part at one hospital in London.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fetal Pillow (inflatable device) and Tydeman Tube (manual device)
- What this could lead to
- If successful, this could show which device makes emergency C-sections safer and faster for both mother and baby when the fetal head is stuck.
- What could go wrong
- This is a small, single-center observational study, not a randomized trial. Results may not apply to all hospitals, and neither device is a guaranteed solution.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
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How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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