Expert Review
ajog.org
Intrauterine devices in the management of
postpartum hemorrhage
Eve Overton, MD; Mary D’Alton, MD; Dena Goffman, MD
Obstetrical hemorrhage is a relatively frequent obstetrical complication and a common
cause of maternal morbidity and mortality worldwide. The majority of maternal deaths
attributable to hemorrhage are preventable, thus, developing rapid and effective means
of treating postpartum hemorrhage is of critical public health importance. Intrauterine
devices are one option for managing refractory hemorrhage, with rapid expansion of
available devices in recent years. Intrauterine packing was historically used for this
purpose, with historical cohorts documenting high rates of success. Modern packing
materials, including chitosan-covered gauze, have recently been explored with success
rates comparable to uterine balloon tamponade in small trials. There are a variety of
balloon tamponade devices, both commercial and improvised, available for use. Efficacy
of 85.9% was cited in a recent meta-analysis in resolution of hemorrhage with the use of
uterine balloon devices, with greatest success in the setting of atony. However, recent
randomized trials have demonstrated potential harm associated with improvised balloon
tamponade use In low resource settings and the World Health Organization recommends
use be restricted to settings where monitoring is available and care escalation is possible.
Recently, intrauterine vacuum devices have been introduced, which offer a new
mechanism for achieving hemorrhage control by mechanically restoring uterine tone via
vacuum suction. The Jada device, which is is FDA-cleared and commercially available in
the US, found successful bleeding control in 94% of cases in an initial single-arm trial,
with recent post marketing registry study described treatment success following hemorrhage in 95.8% of vaginal and 88.2% of cesarean births. Successful use of improvised
vacuum devices has been described in several studies, including suction tube uterine
tamponade via Levin tubing, and use of a modified Bakri balloon. Further research is
needed with head-to-head comparisons of efficacy of devices and assessment of cost
within the context of both device pricing and overall healthcare resource utilization.
Key words: antihemorrhagic intervention, blood loss, intrauterine vacuum device,
maternal morbidity, obstetrical hemorrhage, obstetrics, postpartum hemorrhage,
pregnancy complication, uterine atony, uterine balloon tamponade, Intrauterine packing,
Bakri, Jada, Ellavi, ebb, BT-Cath, Suction tube uterine tamponade
From the Department of Obstetrics and Gynecology, Columbia University, New York, NY.
Received May 31, 2023; revised July 28, 2023; accepted Aug. 10, 2023.
M.D. reports serving in a leadership role in the American College of Obstetricians and Gynecologists
II’s Safe Motherhood Initiative, which has received unrestricted funding from Merck for Mothers, and
serving on the board of March for Moms. D.G. reports serving on the scientific advisory board for the
Jada device through Organon and serving as a principal investigator for the PEARLE and RUBY Jada
trials. D.G. also reports participating in the Cooper Surgical Obstetrical Safety Council, creating
postpartum hemorrhage education with Laborie, Haymarket, and PRIME, and serving as an editor for
UpToDate. E.O. reports no conflict of interest.
Corresponding author: Eve Overton, MD. eo2393@cumc.columbia.edu
0002-9378/$36.00
ª 2023 Elsevier Inc. All rights reserved.
https://doi.org/10.1016/j.ajog.2023.08.015
S1076 American Journal of Obstetrics & Gynecology MARCH 2024
Background
Postpartum hemorrhage (PPH) is a
common complication, affecting up to
5% of births, and is a leading cause of
maternal morbidity and mortality
worldwide.1e4 In low- and middleincome nations where the majority of
maternal deaths occur, more than 30%
of maternal deaths are attributable to
hemorrhage.4 However, PPH also remains problematic in high-resource
settings, including the United States,
where hemorrhage accounted for 12.1%
of maternal deaths from 2017 to 2019.5
Furthermore, the rate of PPH is
increasing and the majority of deaths
caused by PPH are considered to be
preventable.6,7 Thus, ensuring mechanisms to rapidly and effectively treat
PPH is a critically important public
health priority.
Although there are multiple potential
PPH etiologies, 70% to 80% are associated with uterine atony.8 Second-line
therapies for refractory hemorrhage
caused by atony traditionally include a
uterine balloon tamponade (UBT),
manual compression maneuvers, interventional radiology procedures, and
nonpneumatic antishock garments
before operative intervention methods
are considered.1,9,10 There has been a
recent expansion of UBT devices, and the
new development of intrauterine vacuum devices present an alternative
(Table). Given the recent change in
technology available to manage refractory PPH, the purpose of this review
was to provide a summary of the existing
devices and their supporting data.
Rationale for tamponade techniques
Tamponade techniques have been used as
second-line therapy for atony-related
PPH before surgical intervention, typically with packing or a balloon
completely filling the atonic uterine cavity to apply pressure to the bleeding
myometrium. There are two theories
ajog.org
TABLE
Summary of selected intrauterine devices for postpartum hemorrhage management
Device
description
Indications
assessed in
previous
studies
Plain gauze
sponges
Standard sterile
cloth gauze and
sponges
Chitosancovered gauze
Sterile gauze or
packing coated
in chitosan or
standard gauze
with chitosan
powder applied
Mini-sponge
tamponade
device
Atony
Mini-sponges
secured within a
strong, porous
pouch to facilitate
manual vaginal
removal
Device
Maximum
filling volume
Suction
level
Duration of
use
Atony,
placental
pathology
N/A
N/A
24 h
Low cost, readily Concerns
available
regarding
infection risk,
inadequate
tamponade
Atony,
placental
pathology
N/A
N/A
Maximum
described
indwelling of
48 h
Cost availability, N/A
Chitosan
limited available
granules swell
to form plug that data on outcomes
aids hemostasis,
works in
hypothermic
conditions and
independently of
body’s clotting
mechanism.
N/A
N/A
0.5e24 h
Rapid use, ease
of placement, no
fixed shape, thus
may conform to
irregular uterine
cavity
500 mL
N/A
Max 24 h
Rapid instillation Vaginal packing
may be needed,
from an IV or
syringe, drainage intrauterine
port allows efflux, drainage port
protrudes past
latex free, best
balloon surface
studied UBT
Features
Limitations
Manufacturer reported
contraindications
Selected
outcomes data
N/A
Maier13, Rezk
et al15, Guo et al16
Packing devices
Mueller et al18,
Rodriguez et al20
Purpose-driven uterine balloon tamponade
Bakri Cook
Medical
Single silicone
balloon with
central lumen
catheter
Atony,
placental
pathology
Overton. Intrauterine devices for postpartum hemorrhage management. Am J Obstet Gynecol 2024.
Bakri et al22, Said
Arterial bleeding requiring
surgical exploration or
et al23
Embolization, hysterectomy
indicated, ongoing pregnancy,
cervical cancer, purulent
infection, untreated uterine
anomaly, disseminated
intravascular coagulopathy,
surgical site that would prohibit
device from effectively
controlling bleeding
(continued)
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N/A
Availability,
limited outcomes
data reported
following vaginal
birth only
Dueckelmann
et al17; Carles
et al19
Summary of selected intrauterine devices for postpartum hemorrhage management (continued)
Device
Device
description
Indications
assessed in
previous
studies
Maximum
filling volume
Suction
level
Duration of
use
Features
Limitations
Manufacturer reported
contraindications
Selected
outcomes data
Uygur et al24
Arterial bleeding requiring
surgical exploration or
embolization, hysterectomy
indicated, ongoing pregnancy,
cervical cancer, purulent
infection, untreated uterine
anomaly, disseminated
intravascular coagulopathy,
surgical site that would prohibit
the device from effectively
controlling
bleeding, postpartum, vaginal
bleeding unaccompanied by
uterine bleeding
Atony,
Single, soft
silicone balloon placental
pathology
with lumen
allowing
intrauterine
blood drainage
that allows timely
confirmation of
the tamponade
effectiveness
500 mL
N/A
Max 24 h
Vaginal packing
Intrauterine
may be required,
drainage port
limited available
flush with
balloon surface, outcomes data
rapid instillation
with IV or syringe,
drainage port
allows efflux,
latex free
ebb Complete
Tamponade
System
Atony
Double
polyurethane
balloon system
with intrauterine
and vaginal
balloon
components.
Separate lumens
fill the balloons
individually
N/A
300 mL
(vaginal balloon)
750 mL
(intrauterine
balloon)
Max 24 h
Arterial bleeding requiring
Two ports
Larger max
surgical exploration or
required for
intrauterine
embolization, cases with
volume, reports inflation,
hysterectomy indicated,
placement in
better ability to
open hysterotomy ongoing pregnancy, cervical
conform to
cancer, purulent infection,
discouraged,
cavity because
limited available untreated uterine anomaly,
of balloon
disseminated intravascular
material, optional outcomes data
coagulation, surgical site that
use of vaginal
would prohibit device from
balloon may
effective bleeding control,
reduce expulsion,
postpartum vaginal bleeding
rapid inflation
unaccompanied by uterine
from IV or syringe,
bleeding
drainage port
allows efflux
McQuivey et al25
Ellavi
Atony
Single silicone
balloon
connected to
tubing with IV bag
1000 mL
Max 24 h
Limited available
Low cost,
outcomes data
preassembled,
rapid deployment
from IV tubing
allows for egress
of balloon fluid
with resolution of
atony while
maintaining
constant pressure
Theron and
Mpumlwana31;
Parker et al32
N/A
Overton. Intrauterine devices for postpartum hemorrhage management. Am J Obstet Gynecol 2024.
Bleeding as a result of a
perineal, vaginal, or cervical
tear, congenital uterine
anomaly, uterine rupture,
cases of retained placenta
(continued)
ajog.org
BT-Cath Utah
Medical
Expert Review
S1078 American Journal of Obstetrics & Gynecology MARCH 2024
TABLE
ajog.org
TABLE
Summary of selected intrauterine devices for postpartum hemorrhage management (continued)
Device
Device
description
Indications
assessed in
previous
studies
Maximum
filling volume
Suction
level
Duration of
use
Features
Limitations
Manufacturer reported
contraindications
Selected
outcomes data
N/A
Keriakos and
Mukhopadhyay26
Improvised uterine balloon tamponade
Natural latex
single balloon
Atony,
placental
pathology
500 e1500 mL N/A
Max 24 h
Potential for large Off-label use,
vaginal packing
volume of
may be required
inflation
SengstakenBlakemore
Tube
Natural latex
dual balloon
Atony,
placental
pathology
250 mL (gastric N/A
balloon)
Max 24 h
Two-balloon
catheter may aid
with placement,
drainage port
allow efflux
Off-label use,
Long tip on
catheter must
be trimmed to
aid proper
placement
N/A
Seror et al27
Condom
catheter
Latex, plastic,
lambskin
Condom affixed
to a straight
urinary catheter
kit
Atony,
placental
pathology
500 mL
N/A
Max 24 h
Designed for and
tested in
resource-poor
settings, may
assemble out of
available local
resources, low
cost
N/A
Improvised
device requiring
assembly, need
to clamp catheter
to avoid efflux of
fluid filling
balloon, single
lumen catheter
may not allow
drainage of blood
from uterus
Anger et al36
N/A
8010 mm
Hg
1.5e24 h
FDA-cleared,
purpose-driven,
ease of use
Cost, availability, <3 cm of cervical dilation,
requires 3 cm ongoing intrauterine pregnancy,
abnormal uterine anatomy,
of cervical
active cervical cancer,
dilation,
unresolved uterine inversion,
hysterotomy
untreated uterine rupture,
must be closed
before placement, purulent infection
less data for
uterine size <34
weeks’ gestation
Purwosunu
et al47, D’Alton
et al43, Gulersen
et al49, Goffman
et al48
Intrauterine Vacuum Devicesa
Jada System
Atony
Elliptical
intrauterine loop
made of medical
grade silicone
lined with vacuum
pores oriented
inward along the
loop covered by a
soft shield,
balloon-occlusion
cervical seal
external tubing
Overton. Intrauterine devices for postpartum hemorrhage management. Am J Obstet Gynecol 2024.
(continued)
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Rusch urologic
hydrostatic
balloon
Summary of selected intrauterine devices for postpartum hemorrhage management (continued)
Device
Device
description
Indications
assessed in
previous
studies
Maximum
filling volume
Suction
level
Duration of
use
Features
Limitations
Manufacturer reported
contraindications
Selected
outcomes data
Rigid uterine
retraction
cannulas
Atony
25 cm length
and 12e18 mm
in width stainless
steel cannula,
perforations on
uterine portion.
The perforations
on fundal portion
are large and
longitudinal and
round and small
on cervical
portion
N/A
650 mm Hg
Reusable,
10 min on
purpose driven
suction
repeated
every h for 3 h
Limited outcomes N/A
data, unavailable
in the United
States
Samartha Ram
et al50, Panicker51
Suction tube
uterine
tamponade
(STUT)
Wide-bore (FG24 Atony
to FG36) Levin
suction tube is
connected by
suction tubing to
an adjustable
electronic suction
pump or wall
suction source.
N/A
Low cost,
100e200 mm 1 h with a
readily available
Hg used
20-minute
components
period of
monitoring
without
suction before
removal.
N/A
Improvised
device, requires
manual
stabilization while
initiating vacuum
Hofmeyr et al53,
Hofmeyr and
Singata-Madliki52
Modified Bakri
Atony,
Single silicone
placental
balloon filled to
pathology
50e100 mL
fluid and catheter
attached to
external
nonsterile suction
100 mL
60e70 kPa
(450e525
mm Hg)
N/A
Haslinger et al55
1e24 h
Commercially
available device,
lower device cost
than Jada
Off-label use,
outcomes
restricted to
single study
Expert Review
S1080 American Journal of Obstetrics & Gynecology MARCH 2024
TABLE
FDA, US Food and Drug Adminsitration; IV, intavenous; UBT, uterine balloon tamponade.
a
All vacuum devices require settings with access to reliable vacuum suction source or suction cannister.
Overton. Intrauterine devices for postpartum hemorrhage management. Am J Obstet Gynecol 2024.
ajog.org
Expert Review
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on how a tamponade achieves hemostasis. The first is that the intrauterine
tamponade device exerts direct inwardto-outward pressure greater than systemic arterial pressure, thus inhibiting
bleeding from the spiral arteries.11 A
more recent theory posits that hydrostatic pressure from the tamponade device directly compresses the uterine
arteries, which is similar to the mechanical effect of uterine artery ligation.12
Intrauterine packing
The earliest method of uterine tamponade, described in the 19th century, was
uterine packing with plain gauze.13,14
Although rates of hemorrhage control
reached 100% in some reports, concerns
regarding infection risk and inadequate
tamponade led to the abandonment of
this practice in the 1950s.13 There has
been a resurgence in the use of uterine
packing with modern materials with
results and complication rates similar
to a balloon tamponade.15,16 Small
studies have described the feasibility of
gauze impregnated with hemostatic
agents, theoretically providing local
procoagulant effects in addition to
tamponade.15,17e19 One retrospective
cohort study evaluated 78 patients with
refractory PPH, and 47 (60.3%) received
a chitosan-covered gauze tamponade,
whereas 31 (39.7%) received a UBT according to provider discretion. There
was no significant difference in the
clinical outcomes between groups,
including in the mean estimated blood
loss (EBL) (2017 mL gauze; 1756 mL
UBT; P¼.225), average units of red blood
cell (RBC) transfusion received (1.9
units gauze; 1.5 units UBT; P¼.66),
intensive care unit admission (44.5%
gauze; 61.3% UBT), or hysterectomy
(0% gauze vs 9% UBT). This study was,
however, limited by sample size and its
nonrandomized, retrospective design.17
In addition to impregnated gauze options, a mini-sponge tamponade device
made from a trauma dressing has been
described. An initial feasibility study of 9
patients has been published with successful placement and control of hemorrhage in all.20 Further data are needed
to assess the safety and efficacy of these
techniques.
Uterine balloon tamponade devices
The majority of modern uterine tamponade techniques are balloon devices.
The first and best studied of these devices
is the Bakri balloon, initially described in
the literature in 1999 (Figure 1).21e23
Multiple alternative UBTs specifically
designed for obstetrical hemorrhage are
commercially available, including the
BT-Cath Balloon Tamponade Catheter
and the ebb Complete Tamponade System.24,25 Use of a variety of improvised
devices has also been described,
including modified Foley catheters, the
Rusch balloon, condom catheters, and
Sengstaken-Blakemore tubes.26e28 With
these techniques, an examination is first
performed to assess for lacerations,
retained products of conception, or
other bleeding sources, followed by a
sweep of the uterine cavity with removal
of any tissue or clot. A balloon is placed
manually into the uterus with proper
placement above the cervix confirmed
manually or via ultrasound. The balloon
is then inflated with warm saline until
resistance is encountered and the device
is securely affixed to the patient’s leg to
maintain tamponade.22 All uterinespecific devices offer the option of
rapid intravenous- or syringe-based
inflation, although data on comparative
device
deployment
times
are
limited.22,24e26,29 Maximum recommended volumes for the intrauterine
balloon vary among devices with the
lowest volume Sengstaken-Blakemore
balloon at 250 mL and the largest volume Rusch balloon at 1500 mL.25,26 The
tamponade test can be performed to
confirm successful placement. A positive
test is defined by a rapid reduction in
bleeding with partial or full inflation of
the balloon. A negative test , defined by
continued bleeding despite proper UBT
placement, should be followed by device
removal and timely transition to other
inteventions.11 A subset of UBTs include
a catheter lumen that allow for drainage
and quantification of ongoing blood
loss, including the Bakri, ebb, BT-Cath
balloon system, and SengstakenBlakemore tube.22,24,25,27
Vaginal packing is often required to
maintain appropriate placement, and
patients are closely monitored during
FIGURE 1
Bakri postpartum balloon
tamponade device
Image Courtesy of Cook Medical. Used with
permission.
Overton. Intrauterine devices for postpartum hemorrhage
management. Am J Obstet Gynecol 2024.
device use. Balloon displacement occurs
in approximately 10% of cases.23 Of
note, the Sengstaken-Blakemore and ebb
devices contain an additional vaginal
balloon that may reduce expulsion and
the need for vaginal packing.25,27 Deflation and removal may occur up to 24
hours after placement. In one retrospective study, 75% of participants underwent UBT removal more than 12
hours after placement.30
Novel UBTs continue to be developed.
The Ellavi System intrauterine balloon is
a gravity-fed, free-flow balloon system
that maintains constant pressure while
allowing fluid to be expelled from the
balloon as the uterus contracts,
responding to the theoretical criticism
that fixed-volume balloons obstruct
physiologic
uterine
contraction
(Figure 2).31,32 In addition, this device
has a lower cost than other purposedriven UBTs with a current reported
cost of 15 USD.33
Uterine balloon tamponade outcomes
A recent meta-analysis, including 4791
patients from 91 studies, indicated
85.9% efficacy in resolution of hemorrhage with the use of UBT devices with
the greatest success in the setting of
atony (87.1%). Success was greater
following vaginal birth (87.0%) as
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FIGURE 2
Ellavi uterine balloon tamponade device and quick setup reference instructions
Images courtesy of Sinapi Biomedical. Used with permission.
Overton. Intrauterine devices for postpartum hemorrhage management. Am J Obstet Gynecol 2024.
opposed to cesarean birth (81.7%).28
However, the evidence on UBT efficacy
and safety from randomized and nonrandomized studies is conflicting.34
Observational, nonrandomized, and
retrospective trials have generally shown
benefit of UBT with good safety profiles
and reported complication rates of
6.5%.23,28 However, these study structures carry a risk for reporting bias. In
contrast, 2 recent randomized trials have
demonstrated potential harm associated
with UBT use. A randomized controlled
trial compared the use of a condomcatheter UBT and misoprostol with
misoprostol alone for PPH following
vaginal birth in a low-resource setting.
The results of this study were notable
for a significantly increased proportion
of patients with an EBL >1000 mL
(relative risk [RR], 1.52; 95% confidence interval [CI], 1.15e2.00; P¼.01)
and a higher case fatality rate group
(10%; 6/57 compared with 2%; 1/59) in
the UBT with misoprostol arm when
compared with the misoprostol only
arm.35 Similarly, a cluster-randomized
trial on the use of a condom catheter
UBT performed in low- and middleincome settings showed an association
with the increase in the combined
incidence
of
hemorrhage-related
surgery and maternal death, with 6.7
events/10,000 deliveries during the
control period and 11.6 events/10,000
deliveries during the intervention
period (adjusted incidence rate ratio,
4.08; 95% CI, 1.07e15.58).36
It has not been determined whether
the disparity in study findings reflects
differing research designs, device types,
or differential access to other essential
components of PPH care. As of 2021, the
World Health Organization recommendations for hemorrhage management
specify that UBTs should be used only in
contexts with access to monitoring for
patient clinical status after placement
and access to immediate surgical intervention and blood products.37
There are several additional potential drawbacks of UBT techniques. The
risk for concealed bleeding above the
balloon is a safety concern, particularly with those devices that do not
include a drainage port.14 The risk for
infection associated with an indwelling
foreign body is a concern, although
assessment of device-related infection
risk is challenging because patients
with refractory hemorrhage have high
baseline infection rates of 4.6% to
12.2%.23,38e40 The use of UBTs may
also extend maternal care in higher
S1082 American Journal of Obstetrics & Gynecology MARCH 2024
acuity settings during their indwelling
time. This care may impact healthcare
costs and contribute to known
downstream effects of PPH, including
delayed patient mobilization, longer
parent-child dyad separation, and
reduced early lactation success.41,42
Rationale for uterine vacuum devices
Recently, intrauterine vacuum-induced
hemorrhage control devices have been
developed with the goal of rapid and
effective control of PPH. The rationale
for such devices is to use negative pressure within the uterine cavity to
promote contraction, thus allowing
coiling of the spiral arteries and reduced
blood flow.43
Jada system
The only commercially available device
in the United States is the Jada System,
which was US Food and Drug Administration (FDA)ecleared in August
2020.43e46 This device is made of soft
silicone and consists of an elliptical intrauterine loop on the distal end of a
tube intended for 1-time use. The intrauterine loop is lined with vacuum
pores oriented inward along the loop. A
soft shield covers the outside of the loop.
A balloon providing a cervical seal is
Expert Review
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FIGURE 3
The Jada System intrauterine vacuum-induced hemorrhage-control device
The Jada System intrauterine vacuum induced hemorrhage-control device. The device consists of a soft silicone intrauterine loop lined with vacuum
pores and covered with a protective shield, a cervical seal, and in-line tubing for inflation of the seal valve and connection to tubing for an external vacuum
source. Image courtesy of Organon Health. Used with permission.
Overton. Intrauterine devices for postpartum hemorrhage management. Am J Obstet Gynecol 2024.
located proximal to this loop with separate tubing. The device connects to
sterile vacuum tubing with an inline
canister and a regulated vacuum source
(Figure 3).44
The device is placed transvaginally
and manually for all modes of delivery
with placement following hysterotomy
closure in the setting of a cesarean delivery. The internal loop is placed to the
fundus, oriented in the frontal plane of
the body by confirming the seal valve is
oriented at either the 3- or 9-o’clock
position. After placement, the cervical
seal is inflated with 60 to 120 mL of
sterile water. The device tubing is then
connected to a vacuum at 8010 mm
Hg. Bleeding is quantified by the volume
drawn into the canister and external
tubing (Figure 4). The uterine fundus
may be palpated externally or visualized
using ultrasound. Device failure is indicated by inability to place the device,
failure of the vacuum seal, or ongoing
bleeding despite evidence of an effective
seal. If device failure is recognized, use
should be discontinued promptly and
other interventions should be pursued in
a timely fashion. Use of the Jada System
may be concurrent with uterotonic
medications. Removal after successful
use may occur 1.5 to 24 hours after
placement at the discretion of the provider. Discontinuation of vacuum suction may first be considered at 60
minutes of device use. The device should
FIGURE 4
Placement of intrauterine vacuum-induced hemorrhage-control device
Placement of intrauterine vacuum-induced hemorrhage-control device after placement with the intrauterine ring within the uterine cavity and the cervical
seal prior to inflation with a syringe (1), with low-level vacuum connected to wall suction at 80mm HG þ/- 10 mm Hg (2) and uterine contraction
following initiation of suction with blood draining to a wall canister (3). Images courtesy of Organon Health. Used with permission.
Overton. Intrauterine devices for postpartum hemorrhage management. Am J Obstet Gynecol 2024.
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remain in place for 30 minutes without
suction with a deflated cervical seal
before removal.44,46
There are several limitations to use of
the Jada system. The Jada device should
not be considered for the management
of retained products of conception or
placenta accreta spectrum disorder.
Appropriate placement cannot be achieved with less than 3 cm of cervical
dilation or via an open hysterotomy.
Abnormal uterine anatomy and intrauterine infection are contraindications
to its use.44 There are less data on Jada’s
use in cesarean deliveries than in vaginal
deliveries, and there are minimal data on
its use in uterine cavities less the 34
weeks’ gestational age in size.43,47
First-in-humans use of Jada was
described in 2016. An initial proof-ofconcept study enrolled 10 patients in
Indonesia from 2014 to 2015 who failed
first-line PPH medical therapy following
vaginal birth. Patients had an EBL of 600
to 1000 mL before device use. In all cases,
the device was successfully placed with
evacuation of 50 to 250 mL of blood
during use and with bleeding control
achieved in <2 minutes. No significant
safety events were described.47
This preliminary study was followed
by an industry-sponsored, prospective,
multicenter, single-arm treatment study
performed at 12 sites in the United States.
The primary efficacy endpoint was control of bleeding not requiring further
escalation of treatment. The primary
safety endpoint was incidence, severity,
and seriousness of device-related adverse
events. Patients were included if they
failed first-line uterotonics and had
atony-related hemorrhage with an EBL
of 1000 to 1500 mL before device placement. Of 107 enrolled patients, 106
received treatment. Of these, 85% had
vaginal births. A total of 94% of cases
had successful bleeding control at a median of 3 minutes and a median EBL
during treatment of 110 mL (interquartile range, 75e200 mL). A total of 40
patients (38%) required transfusion of
any blood product, whereas 5 patients
(5%) received 4 or more units of RBCs.
Eight adverse events were reported,
which resolved without serious sequelae.
Among providers, 98% considered the
ajog.org
device easy to use, and 97% would
recommend its use to others.43
The RUBY trial provides the first
post-market registry of real-world use of
the Jada. This was an observational study
at 16 US centers from October 2020
through April 2022 including 800 patients who were treated with the device
(n¼530 vaginal, n¼270 cesarean). Of
these, 94.3% had uterine atony. Treatment success was defined as no escalation of care following device utilization
and no rebleeding following device
removal. Treatment success was
observed in 95.8% of vaginal and 88.2%
of cesarean births. Mean indwelling time
was 4.6 hours and 6.3 hours following
vaginal and cesarean birth respectively.
In the 49% of patients where time to
bleeding control was available, bleeding
control was achieved in 5 minutes for
73.8% post vaginal and 62.2% post cesarean. Bleeding recurred after removal
in 2.8% of vaginal and 4.1% of cesarean
births. Serious adverse events possibly
related to the device were cited in 0.4%
of cases in both settings.48
There is only 1 study that directly
compared outcomes between a UBT and
the Jada device. An analysis was conducted of a retrospective cohort of 124
patients across 2 centers who underwent
device placement with either a Bakri UBT
or the Jada System for refractory PPH
owing to atony from 2019 to 2021. The
use of Jada was associated with a lower
proportion of patients receiving 4 units
of RBCs (2.8% vs 20.5%; P.01) and a
lower median EBL when compared with
the UBT (1500 mL; range, 1175e2000 vs
1850 mL; range, 1400e2200; P<.02).
However, this study was limited by its
small sample size and nonrandomized,
retrospective structure.49
Alternative uterine vacuum devices
Although the Jada System is the only
purpose-driven uterine vacuum device
available in the United States, alternative
methods have been described in which
novel devices and modifications of
existing technology are used.
Rigid uterine retraction cannulas
The use of reusable, rigid uterine
retraction cannulas has been described
S1084 American Journal of Obstetrics & Gynecology MARCH 2024
in international literature. These are steel
or plastic with a length of 25 cm and a
width of 12 to 18 mm and contain perforations to establish suction using a
bottle or vacuum extraction pump up to
650 mm Hg. In an initial study, 20 patients (16 following vaginal delivery and
4 following cesarean delivery) were
enrolled for PPH that did not respond to
oxytocin and 1 additional uterotonic. In
all cases, bleeding was reportedly
controlled within 3 minutes. Detailed
safety data were not available for this
study.50 A subsequent study of 55 patients (40 vaginal and 15 cesarean deliveries) with PPH were treated with
rigid uterine cannulas. This study
described 5 cases for which lacerations
were the cause of bleeds, 2 cases of
clogged devices, and 2 cases for which
the attached suction canister required
replacement. The author otherwise reported successful hemorrhage control,
but outcome details were limited.51
Suction tube uterine tamponade
A suction tube uterine tamponade
(STUT) is a novel approach described in
several feasibility studies. Levin stomach
tubing was selected because of its physical characteristics (round tip, flexibility,
large pore size) and pricing (<1 USD).
In this method, a wide-bore (FG24 to
FG36) Levin suction tube is introduced
manually into the uterine cavity until the
proximal side hole is at least 5 cm beyond
the cervix and is held in place while
connected to external suction tubing.
Suction is then initiated with pressures
of 100 to 200 mm Hg. If successful,
STUT is continued for 1 hour with a 20minute period of monitoring without
suction before removal.
An initial, randomized, single-center,
double-blind feasibility study enrolled
45 patients who underwent cesarean
delivery in 2018 in South Africa. In this
study, a 36FG Levin Stomach tube was
inserted during cesarean delivery and
placed during hysterotomy closure and
then attached to suction transvaginally,
and patients were randomized to early
suction initiated after hysterotomy
closure or to late suction initiated after
skin closure. The EBL was similar between the groups with a mean EBL of
Expert Review
ajog.org
149 mL (range, 13e466 mL) in the early
suction group and 126 mL (range,
24e462 mL) in the late suction group
and a mean difference of 7.3 mL (95%
CI, 61 to 75; P¼.433). There were no
complications. A subsequent case report
described the use of STUT in 3 cases of
refractory PPH in which STUT was used
successfully to avoid a laparotomy.
Most recently, a pilot randomized
control trial was published that described
the performance of the STUT in comparison with the Ellavi UBT in primary
PPH management at 10 centers in South
Africa. Participants were allocated in a
1:1 ratio, 12 to STUT and 12 to UBT.
Insertion failed in 1 participant in each
group and was recorded as difficult in 3
of 10 STUT insertions and 4 of 9 Ellavi
insertions. There were 2 laparotomies
and 1 intensive care unit admission in the
UBT group.
Modified Bakri balloon
Use of a modified Bakri balloon for
uterine vacuum was described in a single
study. In a single-center, observational
cohort study, 66 patients with primary
refractory PPH of any etiology were
enrolled between 2017 and 2020. The
Bakri balloon was inserted in the same
manner as a traditional UBTand inflated
with 50 to 100 mL of saline, and the
proximal end of the drainage catheter
was connected via tubing to a vacuum
device with 450 to 525 mm Hg of suction
applied. Balloons remained in place on
suction for 1 to 24 hours with frequent
ultrasound assessment of positioning.
All devices achieved adequate suction
without equipment failure. The device
success rate was 86% in women with
uterine atony (n¼44) and 73% in
women with placental pathology
(n¼22). No adverse events were
observed.
Local use at authors’ institution
At the authors’ institution, we employ
both the Bakri intrauterine balloon and
Jada System for PPH management
within the setting of an algorithm based
on hemorrhage stage (Figure 5). As
defined by the Safe Motherhood Initiative (SMI) obstetric hemorrhage checklist, hemorrhage is staged by blood
FIGURE 5
Example of postpartum hemorrhage stageebased treatment algorithm
CBC, complete blood count; CD, cesarean delivery; D&C, dilation and curettage; FFP, fresh frozen plasma; IM, intramuscular;
IR, interventional radiology; IV, intravenous; IVH, intravenous hydration; MTP, massive transfusion protocol; OR, operating room;
Plt, platelets; POC, products of conception; PPH, postpartum hemorrhage; RBC, red blood cell; T&S, type & screen; T&C, type & cross;
TXA, tranexamic acid; VD, vaginal delivery.
Overton. Intrauterine devices for postpartum hemorrhage management. Am J Obstet Gynecol 2024.
loss and clinical status. Stage 1 hemorrhage reflects blood loss of 1000 mL,
while stage 2 hemorrhage is classified as
1000- 1500 mL. Stage 3 hemorrhage reflects an estimated blood loss greater
than 1500 mL or hemorrhage accompanied by vital sign abnormalities, evidence of coagulopathy, occult bleeding
risk, or transfusion of greater than two
units of red blood cells. Finally, cases are
categorized as stage 4 hemorrhage when
cardiovascular collapse occurs.56 We first
consider intrauterine device placement
for a stage I PPH, particularly for those
patients with contraindications to uterotonics, based on the protocol used in
MARCH 2024 American Journal of Obstetrics & Gynecology
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Expert Review
the premarket trial for Jada FDA clearance.43 We again consider intrauterine
device placement with ongoing bleeding
in stage II hemorrhage if not previously
attempted during stage I. For uterine
atony with ongoing bleeding despite
fundal massage and the appropriate
first-line uterotonics in vaginal deliveries, we prefer Jada, although the
Bakri remains acceptable. Jada’s rapid
onset of action, ease of identifying device
success or failure, and short indwelling
time drive this recommendation.43
However, for those cases in which cervical dilation is <3 cm, uterine size less
than 34 weeks’ gestation, or a device
needs to be employed during a cesarean
delivery via a hysterotomy, the Bakri
remains preferred.22,44 For other nonuterine atony causes, such as focal
placental bed bleeding at the time of
cesarean delivery, the Bakri is used.57 For
any intrauterine device, continuous
evaluation of the device efficacy and
ongoing management of hemodynamic
status is critically important. If device
failure is identified, prompt removal and
continuation of other interventions is
pursued. We advise assessment in the
operating room and consideration of
surgical exploration for ongoing blood
loss >1500 mL or in the setting of hemodynamic instability.1,10
Future questions
Intrauterine devices in the management
of PPH are a common and important
component of PPH algorithms, however, additional, large-scale, prospective
data are needed to establish the safety
and efficacy of these devices both in
direct comparison with one another and
with alternative methods. This is a
particular concern in the use of intrauterine vacuum devices when compared
with traditional UBTs. Furthermore,
details of intrauterine device optimization have also not been established fully.
This includes studies on whether device
success is affected by manual vs
ultrasound-guided placement and device efficacy in combination with other
techniques, including uterotonics and
compressive sutures. Additional prospective studies are also needed to
determine the use of intrauterine
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devices in middle- and low-resource
settings. Differential outcomes have
been described for traditional UBTs
based on the context of use, which may
reflect disparities in resources for patient
care or variable efficacy of improvised vs
purpose-driven devices.28,35,36
Although emerging literature on the
use of intrauterine vacuum devices
shows promise, there remain significant
questions regarding their role in the
management of PPH. Most published
research to date has included patients
with EBLS of 1500 mL.43,47e55 The
use of intrauterine vacuums at higher
blood loss or in the setting of coagulopathy has yet to be determined. In
addition, they do not have established
use in the absence of atony. Conversely,
there may be a role for vacuum devices
early in hemorrhage management algorithms as an alternative to uterotonic
medications. However, there is concern
that the use of such devices early within
PPH treatment algorithms may lead to
overuse.58 In addition, there are no
current standardized recommendations
for antibiotic use during the indwelling
time of uterine vacuum devices.
Although low rates of puerperal infection have been described to date, significant infection has been noted in rare
cases and vacuum devices carry those
risks that are inherent to an indwelling
foreign body.43
The cost of intrauterine vacuum devices in comparison with alternative
methods is an important consideration.
Currently, the individual device cost of
the Jada System, a single use item, exceeds that of all other available methods
at an estimated 1000 USD, which may be
prohibitively expensive in lowerresource settings.44 The Bakri, in comparison, has reported costs of 150 to 400
USD in different markets.59 Those
improvised vacuum devices and UBTs
may cost significantly less with cited
costs as low as 1 USD. However, a full
analysis of the cost effectiveness of vacuum devices will require assessment of
the comparative success of devices in
reducing healthcare costs associated with
PPH. A recent retrospective study of
1127 patients at a single health system
demonstrated increasing healthcare
S1086 American Journal of Obstetrics & Gynecology MARCH 2024
costs with increasing severity of hemorrhage. The publication describes variable
direct costs of $9311 for cases of hemorrhage requiring UBT without transfusion, rising to $27,156 for those cases
that required either a transfusion of 4 or
more units of RBCs or a hysterectomy.60
Lowering overall costs while optimizing
patient outcomes should be a goal of
future research.
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