The Use of Vacuum Assisted Delivery Devices and Fetal Subgaleal Haemorrhage

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February 23, 1999 M.D.A. No. 110

To: Chief Executive Officer

Subject: The Use of Vacuum Assisted Delivery Devices and Fetal Subgaleal Haemorrhage

The Therapeutics Products Programme has been notified of four cases in the last five years where the use of Vacuum Assisted Delivery Devices has been associated with lethal haemorrhage into the subgaleal space. This advisory describes this potential for harm and is intended for all Health Care Professionals using these devices as well as those who care for the infants following delivery.

Types of Complications

All infants delivered with Vacuum Assisted Delivery Devices will have a caput succedaneum ("chignon") and this will resolve spontaneously with no ill effects to the child. Subgaleal haematoma (subaponeurotic haematoma) is a life-threatening complication which is estimated to occur in 4 of 10,000 spontaneous vaginal deliveries and in 59 of 10,000 vacuum assisted deliveries.¹

A subgaleal haematoma occurs when blood vessels are damaged and blood accumulates in the potential space between the galea aponeurotic (epicranial aponeurosis) and the periosteum of the skull (pericranium). Haemorrhage into this subgaleal (subaponeurotic) space is not limited by the suture lines of the skull as it is in cephalohaematoma. As a result, subgaleal haemorrhages can extend from the brow ridge to the nuchal ridge and from ear to ear, covering the entire calvarium, with a potential volume of several hundred millilitres. This blood loss can produce profound hypovolaemic damage to the neonate and can be lethal.

The clinical signs of this complication include diffuse swelling of the head and evidence of hypovolaemic shock (eg., pallor, hypotension, tachycardia and increased respiration rate). The signs may be present at delivery or may not become clinically apparent until several hours or up to a few days following delivery. The swelling is usually diffuse, shifts dependently when the infant's head is repositioned and indents easily on palpation. In some cases the swelling is difficult to distinguish from the edema of the scalp. Hypotension and pallor may be the obvious signs while the cranial findings are unremarkable.

Use of Vacuum Assisted Delivery Devices

The Vacuum Assisted Delivery Device should not be regarded as an easier alternative to forceps. The same contraindications to forceps delivery apply to the vacuum.

This device is designed to produce traction upon the fetal scalp, in order to assist the maternal expulsive effort. It is not a device with which to apply rotational forces. The vacuum may be used judiciously to correct attitude (deflexion), if it is properly applied and if traction is correctly oriented.

Health Care Professionals should ensure that devices designed explicitly for Vacuum Assisted Deliveries are used. Use of a modified general purpose vacuum pump or direct connection to the central vacuum system is inadvisable as excessive and uncontrolled suction can easily be generated.

Important Recommendations

The use of Vacuum Assisted Delivery Devices in obstetric practice can be safe and effective provided that appropriate attention is paid to the indications, contraindications and technique. The risks and benefits for the mother and fetus must be fully understood before using these devices.

All Health Care Professionals responsible for the post-natal care of infants whose delivery involved the use of Vacuum Assisted Delivery Devices must be informed of this fact and must monitor the infant for signs of subgaleal haemorrhage.

J.Z. Losos, M.D.
Assistant Deputy Minister

Reference

¹ Plauche WC. Subgaleal hematoma. A complication of instrumental delivery. JAMA 1980; 244:1597-8

Resource Materials

1. Cavlovich Faye E. Subgaleal Hemorrhage in the Neonate. Journal of Obstetric Gynecologic & Neonatal Nursing; Principles & Practice. Volume 24, No.5: 397-404, February, 1994.
2. Smith, SA., et al. Subgaleal Hematoma: The Need for Increased Awareness of Risk. J Fam Pract. V41, No.6: 569-574, December, 1995.
3. Smith, SA., et al. Subgaleal Hematoma: The Need for Increased Awareness of Risk. J Fam Pract. V41, No.6: 569-574, December, 1995.
4. Perrin, RG, Rutka JT, Drake JM, et al. Management and outcomes of posterior fossa subdural hematomas in neonates. Neurosurgery 40:1190-1200, 1997.

Inquiries concerning this Alert should be addressed to the Director, Medical Devices Bureau, Room 1605, Statistics Canada Main Building, Tunney's Pasture, Postal Locator: 0301H1, Ottawa, Ontario, K1A 0L2.
Telephone: (613) 957-4786,
Fax: (613) 957-7318.