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Hemorrhage Management using a Foley Catheter for Uterine Suction
This preprint is the pre-submission version shared under Elsevier acceptable use. The preprint of this article is licensed under CC BY-NC-ND 4.0. The final version of the publication is available above from the American Journal of Obstetrics and Gynecology
Abstract:
Uterine atony is a common cause of hemorrhage postpartum as well as after a miscarriage, but there are limitations on current approved devices for management. A Foley catheter is inserted in the uterine cavity and attached to suction for vacuum induced hemorrhage control. The technique can be used across trimesters and in the case of mullerian anomaly. The bleeding should resolve within 5 minutes of application of a Foley catheter for uterine suction. The method has been applied successfully across different trimesters, effectively resolving bleeding. Using a readily available Foley catheter for uterine suction offers a practical approach to manage hemorrhage, both in resource-limited settings, or in cases where no alternative device is available.
Problem:
Uterine hemorrhage remains a significant complication following spontaneous and induced abortion as well as postpartum, contributing to substantial morbidity and mortality for pregnant patients. This is particularly true in resource limited settings where traditional interventions may not be readily available.1 Vacuum-induced tamponade where a device is introduced in the uterine cavity to apply negative pressure rather was first described as early as 1971.2 Studies have demonstrated its capacity to rapidly stabilize patients in critical settings, as well as to minimize complications associated with excessive blood loss. 3–5 However devices on the market at this time are expensive, and cannot be used in the first, or second trimester, as well as when patients have closed cervix.
Our Solution:
A Foley catheter for uterine suction (FOCUS) can be used across gestational ages using a single-use urinary Foley catheter with a balloon size appropriate for the uterine size. Before placement, any clots, tissue, and debris should be cleared from the uterine cavity, if possible. The Foley catheter is then inserted into the uterine cavity, ensuring the balloon is positioned past the internal os, either under direct visualization with a speculum and ring forceps or through a digital examination. The balloon is then filled to capacity with sterile saline, then the open end of the Foley catheter is connected to suction tubing to create negative pressure between 80 mmHg and 525 mmHg. The catheter should remain in place for at least one hour and no longer than 24 hours. Consideration for antibiotic prophylaxis should be given.
FOCUS has been used by Obstetricians and Gynecologists, and subspecialists in Complex Family Planning and Maternal Fetal Medicine in multiple hemorrhage cases in three hospitals in New York, USA. Two of these after 2nd and 3rd trimester delivery are published in a prior report.6 In all instances, vacuum-induced tamponade was deemed the best management option by the treating physician, and no suitable FDA-approved device was available for their specific indication. Given the physicians’ prior experience with Foley catheters for tamponade and vacuum hemorrhage control, suction was incorporated into the clinical care. FOCUS has also been used in the setting of 1st trimester pregnancy loss, cesarean delivery, and mullerian anomalies.
Technical specifics of 24F latex 30cc balloon (Becton, Dickinson and Company, New Jersey USA): Foley 30 cc balloon when filled measures 4.3mm, has two 8mm holes and can apply suction up to 700 mmHg of negative pressure in our testing.
Discussion:
Various techniques are employed to control postpartum bleeding, including massage, medications, devices, and surgical procedures. While vacuum-induced hemorrhage control has shown promise, the currently FDA-approved device is only suitable for those with a dilated cervix and immediately postpartum term or late preterm uterus. In contrast, using an off-label Foley catheter for uterine suction offers several advantages. It is a low-cost, widely available tool already commonly used for uterine tamponade by obstetricians and gynecologists, and the use of suction may further support uterine contraction. Furthermore, the Foley catheter can be used regardless of gestational age or cervical dilation.
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[7] JADA System Vacuum-induced Hemorrhage Control System, INSTRUCTIONS FOR USE.