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The National Institute for Health and Care Excellence (NICE) issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on Insertion of a balloon device to disimpact an engaged fetal head before an emergency caesarean section in March 2015. NICE is currently updating this guidance. The new guidance will be published shortly. Until then the NHS should continue to follow the recommendations outlined in the current version of the guidance. The Interventional Procedures Advisory Committee (IPAC) will consider this procedure review and NICE will issue an interventional procedures consultation document about its safety and efficacy for 4 weeks’ public consultation. IPAC will then review the consultation document in the light of comments received and produce a final interventional procedures document, which will be considered by NICE before guidance is issued to the NHS in England, Wales, Scotland and Northern Ireland.
 
 
Status Awaiting development
Technology type Procedure
Decision Selected
Reason for decision Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
Process IP
ID number 1217
Description Insertion of a balloon device to disimpact an engaged fetal head aims to elevate the fetal head, without trauma, immediately before an emergency caesarean section, usually at full dilatation. A disposable soft silicone balloon device is inserted into the vagina, using a lubricant. It is pushed posteriorly towards the coccyx and placed between the pelvic floor and the fetal head, usually at full dilatation of the cervix. The balloon surface is in contact with the fetal head while the base plate of the device rests on the anococcygeal ligament, preventing any downward movement during inflation. This is similar to the placement of a ventouse cup. Once the device is in position, the mother’s legs are placed flat on the operating table, and the balloon is inflated using sterile saline via a tube connected to a 2-way tap. The balloon is designed to inflate only in an upward direction. The engaged fetal head is elevated out of the pelvis by a few centimetres. The intention is to make the delivery easier with less manipulation and to reduce the risk of injury. Immediately after delivery the balloon is deflated by opening the 2-way tap, and the device is removed from the vagina by traction. Following the caesarean, the vagina is inspected for trauma.

Provisional Schedule

Interventional procedure consultation 27 June 2022 - 25 July 2022
Expected publication 16 November 2022

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Timeline

Key events during the development of the guidance:

Date Update
11 May 2022 Awaiting development. Status change linked to Topic Selection Decision being set to Selected
08 July 2021 Topic selection. IPAC 0

For further information on how we develop interventional procedures guidance, please see our IP manual