A slippery hydrogel membrane, similar to a soft contact lens, is being developed to ease the passage of a baby’s head through the birth canal during difficult labours. Complicated second-stage labour affects up to 30% of first-time mothers—over 100,000 births annually in England and Wales—often requiring forceps, vacuum extraction, or caesarean section. The problem is friction: vaginal resistance can slow progress and prevent the fetal head from rotating into the optimal position. While veterinary medicine routinely uses lubricants for difficult births, no equivalent exists for human maternity. The BirthGlide device works by releasing water under pressure, creating an ultra-low-friction interface. Proof-of-concept testing has already shown it markedly reduces the force needed in simulated births. The team will first refine and manufacture the device to regulatory standards, then test it in 22 women to assess safety, feasibility, and acceptability. A health-economic analysis will model potential cost savings for the NHS from reduced complications and interventions. If successful, this could transform management of obstructed labour—reducing physical trauma, emergency caesareans, and the long-term psychological toll on mothers—without requiring new surgical skills or expensive equipment.
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Background Complicated second stage of labour affects up to 30% of first-time mothers and requires intervention with instruments (forceps/vacuum) or caesarean section. It affects over 100,000 births annually in England and Wales causing physical and psychological trauma, with huge personal, social and financial costs. Slow progress occurs when the propulsive forces on the fetal head fail to overcome pelvic resistance. Resistance is dependent on pelvic bones and soft tissue, fetal head size and position, and vaginal friction. Friction also contributes to fetal head malposition by inhibiting spontaneous head rotation and flexion. Vaginal lubrication is widely used to assist veterinary births, but there is no maternity equivalent that reduces vaginal friction to optimise fetal head position and reduce resistance, despite considerable potential benefits. BirthGlide consist of an ultra-lubricious hydrogel membrane similar to soft contact lenses. When the hydrogel is subject to a high loading pressure, water is excreted and constitute a mesh-confined lubrication, resulting in a stable and ultra-low friction interface. Proof-of-concept testing demonstrate a marked reduction in expulsive forces/energy needed for in simulated births. Aims and objectives To develop, test and manufacture the device to MHRA requirements for clinical study To investigate device safety, feasibility and acceptability in a First-In-Human study To inform the design and conduct of future randomised clinical trials To undertake a health economic analysis to explore potential cost-benefits. Methods In work package 1, clinical (beta) device will be developed for minor design fixes, followed by verification/validation testing, generation of technical files and device manufacture. Work package 2 is a clinical study of 22 nulliparous, induced women with qualitative and quantitative assessments. The device will be placed on the fetal head at the start of the second stage of labour. The first devices will be placed personally by the PI, with formal external review before continuing. The primary feasibility outcome is the rate at which the device is fitted and remains in place for birth; the primary safety outcome is the combined rate of adverse device effect and device deficiency. Work package 3 on health economics will build a decision analytic model to assess the potential cost-effectiveness of BirthGlide, including the costs and outcomes associated with complications and longer-term outcomes. A headroom analysis will inform the threshold of effectiveness as cost-effective use of NHS resources. In Work package 4 there will be a review of intellectual property and patent filing, creation of a dissemination strategy for future studies and commercialisation, and stakeholder engagement. Timelines The first 15 months will be spent in preparing the device and clinical study; the subsequent 6 months on clinical testing with 6 months to analyse and write up. Anticipated impact and dissemination This project will lay the groundwork for the future efficacy trials required for CE / UKCA marking and commercialisation. Publications in high-ranked journals and presentations at national and international conferences will be key. Collaboration with Liverpool Maternity NHS Foundation Trust and University of Liverpool communications teams will ensure timely press releases and media coverage.
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