By Jeanine Mikek, MSN, RN, RNC-NIC, CEN
Nursing Professional Development, IU Arnett Hospital, Lafayette, IN
SYNOPSIS: In this multicenter study across 12 centers in the United States, a vacuum-induced intrauterine device successfully treated 94% of participants who experienced a postpartum hemorrhage with a median time of three minutes to control of bleeding.
SOURCE: D’Alton ME, Rood KM, Smid MC, et al. Intrauterine vacuum-induced hemorrhage-control device for rapid treatment of postpartum hemorrhage. Obstet Gynecol 2020;136:882-891.
Postpartum hemorrhage is a significant cause of maternal morbidity and a majority of cases may be preventable.1 The use of uterotonic agents or intrauterine devices such as the Bakri balloon, and the administration of blood products are in standard protocols for most obstetric facilities and are recommended by the American College of Obstetricians and Gynecologists and the California Maternal Quality Care Collaborative.2,3 Although balloon tamponade devices have demonstrated efficacy in controlling hemorrhage in more than 80% of atony-related cases (95% confidence interval [CI], 84% to 90%), the mechanism of outward pressure seems counterintuitive if the end goal is uterine compression and contraction.4 This study aimed to evaluate the clinical effectiveness of a modern intrauterine device that relies on vacuum suction in contrast to the balloon tamponade method.
The vacuum-induced device is comprised of a silicone loop with 20 vacuum pores that is placed into the uterine cavity after a manual sweep to check for retained placental products. Upon placement, 60 mL to 120 mL of sterile fluid fills the cervical seal to prevent displacement, and the device is hooked to wall suction at 80 mmHG to 100 mmHg to contract the uterine myometrium. The collection of expelled or vacuumed blood can be measured accurately in the suction canister. The device remains in place, with vacuum applied, for at least one hour after hemorrhage is controlled. Once control is established, the vacuum is discontinued and the cervical seal emptied, but the device remains in place for an additional 30 minutes during close observation for further atony or bleeding.
A prospective, observational study was performed at 12 medical centers throughout the United States between February 2018 and January 2020. Inclusion criteria included 34 weeks gestation or later, normal uterine anatomy, and atony-related pre-device placement estimated blood loss (EBL) of 500 mL to 1,500 mL after vaginal delivery or 1,000 mL to 1,500 mL after cesarean delivery. Most facilities were not using quantitative blood loss (QBL) at this time. Consent was obtained by more than 7,500 women prior to delivery in the event a postpartum hemorrhage occurred and the vacuum device could be used. In total, 106 women received treatment with the vacuum-assisted device to control postpartum bleeding.
The majority of women were white (57%) and primiparous (33%), and most deliveries were performed vaginally (85%). Uterine atony was noted as the primary cause of postpartum bleeding in these women with a median EBL of 870 mL for vaginal delivery and 1,300 mL for cesarean delivery. The success rate for the vacuum-induced device was 94% (100/106; 95% CI, 88% to 98%) with a median time of three minutes to control of bleeding. Forty of the women (38%) still required blood products, with the majority (35/40 participants) receiving one to three units. However, evacuated blood when the device was in place was able to be measured and remained a low amount at a median of 110 mL, further supporting the device’s ability to contract the uterus and prevent additional uncontrolled bleeding. Five participants required more significant intervention after the vacuum failed to adequately control bleeding, including uterine balloon tamponade (n = 2), B-Lynch compression suture (n = 1), B-Lynch compression suture followed by hysterectomy (n = 1), and hysterectomy (n = 1).
COMMENTARY
Overall, a vacuum-assisted device was deemed to be effective in controlling postpartum hemorrhage. Enrollment of this study was limited to participants with less than 1,500 mL of blood loss, and, therefore, the effectiveness of the device in potentially reducing the need for blood products is questioned. Although the vacuum-assisted device is newer than the balloon tamponade devices and more research with severe cases of postpartum hemorrhage is needed, results thus far are promising if bleeding control can be achieved in a matter of minutes. The median time of vacuum treatment was 144 minutes in the study, which included 60 minutes with the device in place and 30 minutes for observation with the vacuum disconnected from suction. A tamponade device, such as the Bakri balloon, can stay in place for no more than 24 hours. Logically, the less time a device is left in place in a body cavity the lower the risk for infection, so a vacuum-assisted device would be preferable in this aspect.
One concern that would warrant individual facility investigation is the potential cost of a balloon tamponade device (Bakri) vs. the vacuum-induced device (Jada). For example, upon my own inquiry, I found it would be nearly six times more expensive to stock Jada on the unit and could be nearly four times the amount billed to the patient compared to the Bakri balloon. Since every hemorrhage can be affected by several factors or can respond differently to treatment, it can be difficult to generalize if one device reduces the amount of blood products administered or the need for surgery over the other. However, the cost should not deter facilities from trialing new products that are found to be effective and lifesaving. The Jada device is available to facilities at this time, and I await further information from a local hospital that has it stocked. At the time of this writing, it has not yet been used at the facility, since the need has not been warranted in a postpartum hemorrhage.
REFERENCES
- [No authors listed]. Quantitative blood loss in obstetric hemorrhage: ACOG COMMITTEE OPINION, number 794. Obstet Gynecol 2019;134:e150-e156.
- California Maternal Quality Care Collaborative. OB Hemorrhage Toolkit V 2.0. https://www.cmqcc.org/resources-tool-kits/toolkits/ob-hemorrhage-toolkit
- The American College of Obstetricians and Gynecologists. Obstetric Hemorrhage Bundle. https://www.acog.org/community/districts-and-sections/district-ii/programs-and-resources/safe-motherhood-initiative/obstetric-hemorrhage
- Suarez S, Conde-Agudelo A, Borovac-Pinheiro A, et al. Uterine balloon tamponade for the treatment of postpartum hemorrhage: A systematic review and meta-analysis. Am J Obstet Gynecol 2020;222:293.e1-293.e52.
