Fetal
Pillow®

Hear from Dr Rajiv Varma MB, FRCOG founder and CEO on what led to the development of the Fetal Pillow®

A Cesarean Section performed in the second stage of labour affects around 4% of all births, and carries an increased risk of trauma for both the mother and her baby1, 2. ​Intra-operative complications account for the majority of morbidity and often occur as a result of the increased manipulation required to deliver a deeply impacted fetal head.

Simple

Fetal Pillow® is very simple to use, it is inserted during patient preparation and does not delay starting the procedure.

Safe

Fetal Pillow® enables a gentle and controlled elevation of the deeply impacted head. It is designed to ensure safer and easier delivery, which helps to reduce trauma to both mother and baby.​

Effective

Fetal Pillow® reduces intra-partum and post-partum complications. There is also a significant reduction in blood loss, operating time and length of stay.

Clinical Evidence

Fetal Pillow is intended to elevate a deeply impacted fetal head and facilitate delivery of the fetus in women requiring a Cesarean Section at full dilation or those requiring a Cesarean Section after a failed instrumental vaginal delivery.

Fetal Pillow is indicated for use at a gestational age ≥37 weeks.

Randomized Controlled Trial

Highlights significant reduction in uterine extension tears, PPH, operating time & length of stay

Fetal Pillow® V Hand From Below Study

Highlights significant improvement in cord arterial PH, reduction in blood loss & reduction in length of stay

Case Controlled Study

Prospective study of 50 Fetal Pillow cases compared with historical controls of 124 women.

ACCESS FURTHER EVIDENCE

Randomized Controlled Trial

Highlights significant reduction in uterine extension tears, PPH, operating time & length of stay

Fetal Pillow® V Hand From Below Study

Highlights significant improvement in cord arterial PH, reduction in blood loss & reduction in length of stay

Case Controlled Study

Prospective study of 50 Fetal Pillow cases compared with historical controls of 124 women.

FAQ's

Can Fetal Pillow be used if the cervix is not fully dilated?

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Fetal Pillow is indicated for use in women requiring a Cesarean Section at full dilation or those requiring a Cesarean Section after a failed instrumental vaginal delivery.

Can Fetal Pillow be used patients who have had a previous cesarean section?

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The safety and effectiveness of Fetal pillow has not been established in women who have had a previous cesarean section.

What is Fetal Pillow made of?

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Fetal Pillow is 100% Silicone.

Can Fetal Pillow be inserted in the delivery room?

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Fetal Pillow can be inserted in the delivery room. We recommend that the device is not inflated until you are ready to make the skin incision.

Can you use Fetal Pillow after the Cesarean section has begun if you encounter difficulty?

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No, Fetal Pillow has been designed to be used prophylactically and has not been tested to inflate after the uterine incision has been made.

Can air be used for inflation?

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No, there is a risk of air embolism if the device leaks. More importantly air is compressible, so it would be much less effective compared with fluid and a larger amount would be required to inflate the device.

What are the contraindications?

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The only contraindication stated is "active genital infection". You can refer to the "Warnings" section within the IFU where safety and effectiveness has not been established in those cases and would be at the discretion of the operating surgeon.

Value Analysis

Using Fetal Pillow® to manage the complications associated with managing a deeply impacted fetal head can deliver significant financial savings for a hospital.

Take a look at our brochures for more information on value analysis

USAAustraliaNew ZealandUK

An average cost saving of $7,283 per patient can be achieved through use of Fetal Pillow®

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SAFE OBSTETRIC SYSTEMS LIMITED: a UK company incorporated and registered in England and Wales with a company number 05923369 whose registered office is at Berkeley Townsend, Hunter House, 150 Hutton Road, Shenfield, Brentwood, Essex CM15 8NL.​

SAFE OBSTETRIC SYSTEMS INC has Authority To Do Business in New York State (File Number 170602000493), with a company address for process: Safe Obstetric Systems Inc, Suite #201, 233 East Shore Road, NY 11023.