Clinical Need & Problem

Clinical Need

Post pArtum Hemorrhage

It is estimated that of all births in the US, postpartum hemorrhage occurs in 3-5% of cases [1]. Postpartum hemorrhage is the known cause of around 25% of delivery related deaths globally [2]. It is also important to note that while the maternal death rate is globally decreasing the US is actually one of the few developed countries with a rising rate. It has been reported that the US maternal death rate has more than doubled between 1981 and 2014, from a rate of 0.01% of deliveries in 1981 to a rate of 0.024% in 2014 [3], with postpartum hemorrhage being a leading cause of these deaths.

In the clinical setting, postpartum hemorrhage is presented as excessive blood loss regardless of its primary source. Some amount of blood loss is normal during both vaginal and cesarean births. In 2017, The American College of Obstetrics and Gynecology created a refined definition of postpartum hemorrhage to be 1000 mL of cumulative blood loss with signs of hypovolemia within 24 hours of the birth process; however, due to the fact that blood loss is often underestimated, more than 500 mL of blood loss during vaginal deliveries is still to be considered abnormal [4].

Postpartum hemorrhage is the leading cause of pregnancy-related deaths, and a recent study from the CDC found that hospitals may be able to prevent up to 70% of these deaths [5]. Our device will help bridge this gap and aid in the reduction of these types of deaths.

The pathophysiology of postpartum hemorrhage is largely dependent on the cause of the bleeding, which can be attributed to a variety of factors.

Uterine atony: failure of the uterus to contract adequately following delivery. This lack of contraction can result as a response to endogenous oxytocin that is released during delivery. The delivery of the placenta leaves disrupted spinal arteries that are dependent on uterine contraction after birth due to their lack of musculature. A lack of mechanical closure can prevent these arteries reaching a hemostatic state, causing excessive bleeding [6]

Genital tract laceration: tears in the vaginal wall can occur during vaginal delivery and be a significant source of bleeding depending on the severity of the tears, which is usually dependent on fetal size [7]

Placenta retention: the placenta remains in the womb and isn’t delivered on its own naturally. One source discusses that this is likely caused by the persistence of one of the placental inhibitory factors that are normally reduced prior to the onset of labor, possibly progesterone or nitric oxide [8].

Uterine Inversion: the uterus is turned inside-out during delivery. The cause of this can be attributed to excessive umbilical cord traction with a fundal attachment of the placenta to the uterus and fundal uterine pressure in the setting of a relaxed uterus [9].

PRoblem

Currently, there are no devices on the market to diagnose or quantify post partum hemorrhage.

Current methods include:

Visual estimation of blood loss → results in a high amount of underestimation [6]

Weighing blood-soaking materials → messy, time consuming, can still be inaccurate

Urology drape → fluid drips into drape, meant for urology, may account for unwanted fluids

Analysis of symptoms and lab results → symptoms such as blood pressure and pulse do not appear until it is usually too late

In extreme cases of postpartum hemorrhage, the patient can lose their entire blood volume in 6 to 10 minutes. Time is of the essence in saving their life, and providers need to be able to know quickly how much blood has been lost, so taking the time to weigh pads and get lab results is not ideal. Our device will offer a way for healthcare providers to immediately be able to quantitatively, rather than qualitatively, see how much blood a patient has lost in order to diagnose postpartum hemorrhage faster and improve patient outcomes.

Table 1: Overview of current methods

Economic Impact

Length of Hospital Stay Increases with PPH

Women with non-atonic postpartum hemorrhage: 3.67 days
Atonic (aka uterine atony) postpartum hemorrhage: 2.98 days
“Normal”: 2.63 days [11]

Increased Cost

A vaginal delivery with complications that requires an operating room procedure has the highest average price tag of any type of birth, costing an average of $6,900, nearly double the average cost per stay for all types of delivery [12]

Reducing PPH cases reduces the cost of labor and delivery for the patient

Sources

“Taking on a Leading Cause of Maternal Death: Improving Postpartum Hemorrhage Care,” NICHQ, 21-Aug-2018. [Online]. Available: https://www.nichq.org/insight/taking-leading-cause-maternal-death-improving-postpartum-hemorrhage-care. [Accessed: 13-Oct-2020].
M. Y. A. B. Yiadom, “Postpartum Hemorrhage in Emergency Medicine,” Medscape, 27-Aug-2020. [Online]. Available: https://emedicine.medscape.com/article/796785-overview. [Accessed: 19-Oct-2020].
S. Delbanco, M. Lehan, T. Montalvo, and J. Levin-Scherz, “The Rising U.S. Maternal Mortality Rate Demands Action from Employers,” Harvard Business Review, 28-Jun-2019. [Online]. Available: https://hbr.org/2019/06/the-rising-u-s-maternal-mortality-rate-demands-action-from-employers. [Accessed: 19-Oct-2020].
K. C. Wormer, R. T. Jamil, and S. B. Bryant, “Acute Postpartum Hemorrhage,” StatPearls, Nov. 2019.
Life after postpartum hemorrhage. Association of Ontario Midwives, Ontario, ON, 2017.
P. Gill, A. Patel, and J. W. VanHook, “Uterine Atony,” StatPearls, Jul. 2020.
R. Mikolajczyk, J. Zhang, J. Troendle, and L. Chan, “Risk Factors for Birth Canal Lacerations in Primiparous Women,” American Journal of Perinatology, vol. 25, no. 5, pp. 259–264, May 2008.
A. D. Weeks, “The Retained Placenta,” African Health Sciences, vol. 1, no. 1, pp. 36–41, Aug. 2001.
M. Thakur and A. Thakur, “Uterine Inversion,” StatPearls, Aug. 2020.
T. Lertbunnaphong, N. Lapthanapat, J. Leetheeragul, P. Hakularb, and A. Ownon, “Postpartum blood loss: visual estimation versus objective quantification with a novel birthing drape,” Singapore Medical Journal, vol. 57, no. 06, pp. 325–328, Jun. 2016.
Declercq, Eugene, and Laurie Zephyrin. “Maternal Mortality in the United States: A Primer.” Commonwealth Fund, 16 Dec. 2020, www.commonwealthfund.org/publications/issue-brief-report/2020/dec/maternal-mortality-united-states-primer.

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