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Organisation develops a device to elevate the impacted fetal head out from the pelvis during a second stage caesarean section, reducing morbidity and improving outcomes for mothers and babies

Challenge

    • Caesarean section in the second stage of labour has a high risk of complications for mother and baby often arising due to difficulty to deliver a deeply engaged fetal head
    • Several techniques used to push the head up can cause complications for mother/baby
    • Reduce complications during a caesarean section at full dilation and improve outcomes for mothers and babies

Action

    • Developed the Fetal Pillow to gently elevate the fetal head out from the pelvis and facilitate easier delivery
    • Inserted the device vaginally and placed it in the posterior position towards the coccyx
    • Placed the patient’s legs flat on the operating table and inflated the balloon with 180ml of saline, enabling an average elevation of 3-4 cm of the fetal head

Result

    • Reduced maternal and fetal morbidity, improving outcomes for mothers and babies
    • 77% reduction in uterine extensions and 72% reduction in blood transfusions
    • 62% reduction in Neonatal Intensive Care Unit stays over 24 hours
    • 20 minute reduction in operating time and 1 day reduction in the length of stay
    • Enhanced clinicians’ ability to perform emergency procedure safely

* Please provide a brief outline of your work. 

‘In the UK, each year over 1000 babies die or are left with severe brain injury because something goes wrong during labour’ (RCOG – Each Baby Counts). Caesarean section in the second stage of labour has a high risk of complications for mother and baby often arising due to difficulty to deliver a deeply engaged fetal head.

Several techniques can be utilised to help with delivery of the head including an assistant pushing the head up vaginally. These techniques can cause complications for both mothers and babies. Fetal Pillow is designed to address this.

 * Please describe the actions you took to achieve your result.

 Fetal Pillow was designed by a consultant Obstetrician & Gynaecologist following the tragic death of a baby that occurred following difficulty to disimpact an engaged fetal head during a second stage caesarean section. Prototypes of the device were designed and tested before the final device was released to the market in 2011.

The Fetal Pillow is deployed prophylactically before the uterine incision is made to achieve full elevation of the fetal head prior to attempts at abdominal delivery, thus reducing the risk of traumatic delivery. The device is inserted vaginally and placed in the posterior position towards the coccyx. The patient’s legs are then placed flat on the operating table before inflating the balloon.

Indications for use of the Fetal Pillow include the following:

• failure to progress at 8-10cm

• failed instrumental delivery

• excessive moulding

Using the Fetal Pillow, an average elevation of 3-4 cm of the fetal head is achieved with fluid volumes of 180 ml, facilitating easier delivery of the fetal head. The use of the devices brings about a number of benefits.

Benefits to the woman and baby:

• Improved patient experience and patient satisfaction

• Less traumatic and more predictable than manual pushing

• Less trauma to the mother and baby, thus reducing recovery time with faster return to normal functioning

Benefits to the clinician:

• Ability to perform emergency procedure safely

• Excellent tactile feel and ease of insertion

• Ability to control the delivery process

• Avoidance of extended operating time, for example, complex suturing post-delivery on large uterine tears.

Benefits to the Trust:

• Reduction in use of ICU and NICU due to reduction in trauma

• Free up bed capacity due to less morbidity, resulting in shorter length of stay.

• Deployment of the Fetal Pillow is easy and quick, thus working towards compliance with NICE Guidance(CG013) which states, ‘Delivery at emergency CS for maternal or fetal compromise should be accomplished as quickly as possible, taking into account that rapid delivery has the potential to do harm.’

• Risk Management - minimise avoidable adverse clinical incidents.

• Contributes to Objective ‘To halve the number of stillbirths, neonatal and maternal deaths and brain injuries by 2030.’

• Supports the RCOG Each Baby Counts project aim of ‘reducing unnecessary suffering and loss of life by 50% by 2020’ Use of Fetal Pillow reduces the overall unit cost of treatment, enabling savings against current practice with an estimated possible saving of £976 per patient when Fetal Pillow is used.

 * Please list the most significant results

 Results from over 500 Fetal Pillow cases that have been studied have shown significant improvements in outcomes for mums and babies. Outcomes from a 240 patient randomised controlled trial are outlined below.

 Reduction in Maternal morbidity:

• 77% reduction in uterine extensions

• 71% reduction in blood loss

• 72% reduction in blood transfusions

 Reduction in Fetal morbidity:

• 77% reduction in APGAR

• 62% reduction in NICU stays over 24 hours

Reduction in use of hospital resources:

• 20 minute reduction in operating time

• 1 day reduction in the length of stay

 * Describe how your project has spread to other teams, departments or organisations

 Since its release into the market in 2011 use of Fetal Pillow has gradually spread. To date over 10,000 devices have been sold worldwide. Fetal Pillow is in use in 20 countries including parts of Europe, Australia, Canada & USA. Within the UK there are 85 hospitals using the device. Fetal Pillow is easy to use and provides an effective solution to a difficult procedure therefore maternity units are able to include it in their practice.

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