Arch Gynecol Obstet
DOI 10.1007/s00404-013-2812-1
MATERNAL-FETAL MEDICINE
A local hemostatic agent for the management of postpartum
hemorrhage due to placenta previa and placenta accreta:
a cross-sectional study
Diego Portilla • Cristian Hernández-Giraldo • Bernardo Moreno •
Fabio Quijano • Luis R. Hoyos • Ana Milena Angarita • Santiago Madero
Received: 12 December 2012 / Accepted: 13 March 2013
Ó Springer-Verlag Berlin Heidelberg 2013
Abstract
Purpose To describe the use of a local hemostatic
agent (LHA) for the management of postpartum hemor-
rhage (PPH) due to bleeding of the placental bed in
patients taken to caesarean section at Fundación Santa Fe
de Bogotá University Hospital.
Sample A total of 41 pregnant women who had a cae-
sarean section and developed PPH.
Methods A cross-sectional study. Analysis of all cases of
PPH during caesarean section presented from 2006 up to and
including 2012 at Fundación Santa Fe de Bogotá University
Hospital.
Main outcome measure Emergency hysterectomy due to
PPH.
Results The proportion of hysterectomies was 5 vs. 66 %
for the group that received and did not receive management
with a LHA respectively (PR 0.07, CI 95 % 0.01–0.51
p \ 0.01). For the group managed without a LHA, 80 % of
patients needed hemoderivatives transfusion vs. 20 %
of patients in the group managed with a LHA (PR 0.24, CI
95 % 0.1–0.6 p \ 0.01). A reduction in the mean days of
hospitalization in addition to a descent in the proportion of
patients admitted to the intensive care unit (ICU) was
D. Portilla
C. Hernández-Giraldo (&)
B. Moreno

F. Quijano
L. R. Hoyos
A. M. Angarita
S. Madero
Gynecology, Obstetrics and Human Reproduction Department,
Fundación Santa Fe de Bogotá Teaching Hospital,
Calle 119 No 7-75, Bogotá, Colombia
e-mail: Cristianhernandezg56@gmail.com
D. Portilla
e-mail: neodifepo@gmail.com
D. Portilla
C. Hernández-Giraldo
L. R. Hoyos
S. Madero
Universidad de los Andes, Bogotá, Colombia
noticed when comparing the group that received a LHA
versus the one that did not.
Conclusion An inverse association between the use of a
LHA in patients with PPH due to bleeding of the placental
bed and the need to perform an emergency obstetric hys-
terectomy was observed. Additionally there was a signifi-
cant reduction in the mean duration of hospital stay, use of
hemoderivatives and admission to the ICU.
Keywords Postpartum Hemorrhage
Cellulose,
Oxidized
Hysterectomy
Placenta previa
Placenta
accreta
Abbreviations
PPH Postpartum hemorrhage
LHA Local hemostatic agent
PR Prevalence ratio
ICU Intensive care unit
Introduction
Postpartum hemorrhage (PPH) is the leading cause of
maternal mortality in developed countries and the second
cause in our country [1]. It is accountable for almost one in
every four maternal deaths worldwide. Estimates show that
there are around 140,000 maternal deaths due to PPH per
year, in other words, one death every 4 min due to PPH [2].
In 2009 there were 510 maternal deaths in Colombia, of
which 59 (11.5 %) were attributable to PPH, being the
second leading cause of maternal mortality in our country
preceded only by hypertensive disorders of pregnancy [3].
Placenta previa and placenta accreta are considered as
important causes of PPH. The incidence of both of these
pathologies as well as their associated complications is on
123

the rise. This rising incidence could be attributed to the
increment of caesarean sections being performed [4–6].
The department of obstetrics and gynecology in our insti-
tution has seen a rise in the caesarean section rate as well.
In 1998 the rate was 47 % and currently the rate is 65 %,
which raises the risk of placenta previa and placenta
accreta and therefore the risk of PPH.
In cases of PPH associated with placenta previa or
placenta accreta were the bleeding of the placental bed
becomes uncontrollable despite the use of uterotonics,
uterine plugging, ligature of the hypogastric arteries,
among others, the last resource is emergency hysterectomy,
which is associated with higher rates of intraoperatory
comorbidity (harm to adjacent organs), postpartum
depression and compromise of future fertility.
The use of local hemostatic agents (LHAs) has been
adopted in different surgical fields including cardiovascu-
lar, urologic and neurologic surgery [7–9]. These agents
have been poorly evaluated in gynecologic surgery and
even less in obstetric surgery. SurgicelÒ FibrillarTM
(Ethicon LLC, Johnson–Johnson, San Lorenzo, Puerto
Rico) is a type of local bioabsorbable hemostatic agent
composed of regenerated oxidized cellulose that provides a
structure or scaffolding for plaquetary adhesion and
aggregation leading to coagulation [8]. There is evidence in
the literature, case reports and case series, about the suc-
cessful use of LHAs on the placental bed to control hem-
orrhage and avoid hysterectomy [10–13]. Yet, there is still
little evidence about the use of regenerated oxidized cel-
lulose in the treatment of obstetric hemorrhage of the
placental bed, especially in patients with placenta previa or
placenta accreta.
The objective of this study is to describe the use of a
LHA for the management of PPH due to bleeding of the
placental bed in patients with placenta previa or accreta
taken to caesarean section at Fundación Santa Fe de Bogotá
University Hospital.
Materials and methods
Cross-sectional study of patients who underwent caesarean
section and developed PPH due to bleeding of the placental
bed, secondary to placenta previa or placenta accreta,
between 2006 and 2012 at Fundación Santa Fe de Bogotá
University Hospital. The center of studies and investigation
in health and the committee of medical ethics of our
institution approved the study’s methodology. The infor-
mation was obtained from electronic medical records,
surgical records, and anesthetic records from the hospital.
We used the definition of the World Health Organization
for PPH: a loss of blood of [1,000 ml during the surgery
[14], and this was estimated through suction collection and
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Arch Gynecol Obstet
the amount of blood absorbed on surgical sponges. To
determine the association between the use of a LHA and a
reduction in the number of hysterectomies performed, two
groups were established through data base analysis. The
groups were established according to the use or not of the
LHA in addition to the usual code-red management pro-
tocol of our institution which is mandatory for every
physician. In the group that used the LHA, if the initial
management of PPH (volume resuscitation, use of utero-
tonics, uterine massage) due to bleeding of the placental
bed secondary to placenta accreta or previa was unsuc-
cessful and bleeding continued, the LHA (generally two or
three gauzes size 5.1 9 10.1 cm) was applied directly to
the bleeding surface on the inside of the lower uterine
segment. If bleeding was severe, no more than 3 min were
waited in order to evaluate the effectiveness of the LHA,
whereas if there was oozing or mild to moderate bleeding,
up to 10 min were waited.
The LHA was started to be used in 2010, the year of its
introduction in our institution, but since it is not a part of
the PPH management protocol it is only used by some of
our physicians allowing us the opportunity to evaluate the
different outcomes in relation to its use. Group 1: Patients
with PPH who were given the usual code-red management
protocol of our institution. Group 2: Patients with PPH who
were given the usual code-red management protocol plus
the use of a LHA (SurgicelÒ FibrillarTM). The code-red
protocol for the treatment of PPH is summarized in Fig. 1.
All placenta previa cases were diagnosed prenatally by
transvaginal ultrasound either during routine scanning or
because of bleeding. In the placentary accretism cases,
40 % were diagnosed prenatally during routine scanning
and the remainders were diagnosed during the surgery
because of difficulty in placental extraction or because of
persistence of placental fragments in the uterine bed after
placental detachment. The prenatal diagnosis of either
placenta previa or accreta did not have an impact on the
allocation of patients on either group.
The primary outcome of our study was the need of
emergency hysterectomy due to PPH. The secondary out-
comes evaluated the use of hemoderivatives, admission to
the intensive care unit (ICU), use of hemostatic sutures
(B-lynch) and days of hospital stay. Other variables mea-
sured were: age, number of pregnancies, births, caesarean
sections, abortions, previous uterine surgery, pathologic
record (e.g. thrombophilias, use of anticoagulant), and
obstetric record (polyhydramnios, multiple pregnancy,
preeclampsia, premature rupture of membranes, active
management of the third stage of labor defined as a pro-
phylactic administration of IV oxytocin and controlled cord
traction, intraamniotic infection, and weight at birth).
For statistical analysis, absolute and relative frequen-
cies, central tendency and dispersion were used. The
Arch Gynecol Obstet

Fig. 1 Management plan for PPH

the treatment of postpartum
hemorrhage
Volume resuscitation (IV Access,
crystalloids, colloids)
Oxytocin
Uterine massage
Baseline laboratory evaluation
Request for blood products

Manual removal under general

anesthesia

Uterine Lacerations, tears, uterine Retained Coagulation

Atony ruptura placenta, abnormalities
placental
fragments
Surgical exploration,
laceration repair
Uterine massage Transfusion
Manual therapy
Oxytocin removal,
Carbetocin curettage
Ergometrine
Misoprostol
Uterine tamponade

Bleeding Stops Bleeding does

not stop

Uterine compression sutures

Arterial ligation
Hysterectomy

association between both groups with primary outcomes
was done using prevalence ratio (PR). A test of difference
in proportions was used to compare the outcomes with the
use of the hemostatic agent. A multiple correspondence
analysis was performed taking hysterectomy as the illus-
trative variable and the use of LHA, gestational age at the
moment of caesarean section, number of pregnancies,
previous record of caesarean section, previous uterine
surgery, history of preeclampsia during pregnancy, multi-
plicity of gestation, and the way labor started (spontaneous,
induced, caesarean section). This analysis is a descriptive
technique that presents in a multivariate way the relation-
ship between variables determined by the proximity to each
other. Calculations were made using Stata: Data Analysis
and Statistical Software 11.0 (Stata Corp LP, Texas, USA).
Results
In 2011 there were approximately 1,133 births at Funda-
ción Santa Fe de Bogotá University Hospital, among which
732 (64.6 %) were delivered by caesarean section. The
leading causes of caesarean section in descending order
were previous caesarean, abnormal labor or dystocia, fetal
distress, caesarean delivery on maternal request and
maternofetal indication such as hypertensive disorders.
Prevalence of PPH in our institution is 0.83 % (a total of 99
cases in the 6 years of study). Of the PPH cases, 46
(46.3 %) presented PPH during caesarean section. Among
the patients who presented with PPH during caesarean
section, 41 (89 %) had abnormal placentation as a cause of
PPH, divided as 10 (24.4 %) with placenta previa and 31
(75.6 %) with placenta accreta, the other 5 cases of PPH at
the time of caesarean section were due to causes other than
abnormal placentation. For Group 1 (management with
usual code-red management protocol) 21 patients were
analyzed and for Group 2 (management with usual code-
red management protocol ? use of a LHA) 20 patients
were analyzed.
Demographic and clinical characteristics of patients
from both groups are presented in Table 1. The average age
was higher for the group in which a LHA was used (36.7
vs. 30.67 years). The number of births was higher for
the group that did not receive management with a LHA

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Table 1 Comparisons between

Characteristic No LHA LHA used Significance
characteristics of the sample and
used (p value)*
the use or not of a local
hemostatic agent n (%) 21(51 %) 20 (49 %)
Age (years) 30.62 (4.5) 36.7 (6.4) \0.01
Gestations 2.05 (1.2) 2.05 (0.88) 0.9
Parity 0.67 (0.73) 0.41 (0.2) 0.01
Caesarean sections 0.38 (0.59) 0.4 (0.59) 0.9
Abortions 0.38 (0.92) 0.45 (0.88) 0.8
Previous uterine surgery n (%) 8 (38.1 %) 9 (45 %) 0.65
Thrombophilias n (%) 0 2 (10 %) 0.13
Anticoagulation n (%) 0 2 (10 %) 0.1
Myomatosis n (%) 1 (4.8 %) 2 (10 %) 0.51
Polyhydramnios n (%) 0 1 (5 %) 0.2
Twin pregnancies n (%) 5 (23.8 %) 0 0.01
Preeclampsia n (%) 2 (9.5 %) 3 (15 %) 0.59
Data are expressed as n (%) or PRM n (%) 0 1 (5 %) 0.29
means (SD) Gestational age at birth (weeks) 36.3 (3) 37.4 (3.1) 0.19
LHA Local hemostatic agent, Active management of the third stage of labor n (%) 21 (100 %) 20 (100 %) –
PRM Premature rupture of
Intraamniotic infection n (%) 0 0 –
membranes
Weight of the newborn (g) 3009 (819) 2769 (636) 0.3
* On the basis of Pearson’s v2
for categorical variables and Weight [ or \ 3000 n (%) 0.36
Student’s t test for continuous \3,000 13 (61.9 %) 15 (75 %)
variables. P \ 0.05, significant [3,000 8 (38.1 %) 5 (25 %)
difference between both groups

(0.67 vs. 0.2 births) and additionally there were five twin
pregnancies in this group vs. none in the SurgicelÒ
FibrillarTM group.
In relation to the management plan for the treatment
of PPH, 41 (100 %) received oxytocin. For the group
managed without a LHA, 14 (66.6 %) were given only
Methergine, 3 (14.2 %) only Carbetocin and 4 (19 %)
Carbetocin and Methergine combined versus 10 (50 %), 3
(15 %) and 7 (35 %) respectively in the group managed
with a LHA. 3 (15 %) patients in the group managed
without a LHA required the use of B-lynch suture vs. 1
(5 %) in the group managed with a LHA. Only one patient
in the group managed without a LHA received tranexamic
acid. No embolism or arterial ligation was used in any of
the cases. In addition, there were no patients with partial
accreta to whom Methotrexate was given.
Table 2 represents the prevalence ratio (PR) for the
evaluated outcomes. For the group that received manage-
ment with a LHA the proportion of hysterectomies done
was 1 (5 %), meanwhile the group that did not receive
management with a LHA the proportion was 14 (66.6 %),
PR 0.07 (CI 95 % 0.01–0.51 p \ 0.01). For the group
managed without a LHA, 17 (80 %) patients needed
hemoderivatives transfusion vs. 4 (20 %) patients in the
group managed with a LHA, PR 0.24 (CI 95 % 0.1–0.6
p \ 0.01). A reduction in the mean days of hospitalization
was also noticed when comparing the group that received a
LHA versus the one that did not (5.6 vs. 3.55 days
respectively, p \ 0.01), in addition to a descent in the
proportion of patients admitted to the ICU (PR 0.28, CI
95 % 0.09–0.87 p \ 0.01). No statistically significant dif-
ferences were found between the use of a LHA and the use
of hemostatic sutures (B-lynch) for bleeding control (PR
0.35, CI 95 % 0.03–3.09 p 0.3). No complications
including infection, sepsis of gynecologic origin, throm-
boembolic events, febrile illness or maternal deaths were
seen.
Correspondence analysis is presented in Fig. 2. From
this analysis we can state that patients who were hyster-
ectomized due to PPH are characterized mainly for having
a gestational age \ 37 weeks, multiple pregnancy, a birth
weight [ 3,000 g and not receiving management with a
LHA. Patients who were not hysterectomized are charac-
terized for having a gestational age [ 37 weeks, single
gestation, birth weight \ 3,000 g and receiving manage-
ment with a LHA.
Discussion
PPH remains as one of the most important causes of
morbidity and mortality in obstetric patients. It has a

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Table 2 Prevalence ratio of outcomes according to the use or not of a local hemostatic agent
Outcome No LHA LHA PR CI 95 % P

Hysterectomy 14 (66 %) 1 (5 %) 0.075 0.01–0.5 \0.01

Use of hemoderivatives 17 (80 %) 4 (20 %) 0.24 0.1–0.6 \0.01
Admission en ICU 10 (47 %) 3 (15 %) 0.28 0.09–0.87 \0.01
B-Lynch sutures 3 (14 %) 1 (5 %) 0.35 0.03–3.09 0.3
Days of hospitalization (mean) 5.6 (2.3) 3.55 (1.2) – (4.5–6.6)/(2.9–4.14) \0.01
Data are expressed as n (%) or mean (SD)
LHA Local hemostatic agent, PR Prevalence ratio, ICU Intensive care unit

Fig. 2 Correspondence
analysis. The association is
determined by the proximity
between the illustrative variable
identified in the box
(hysterectomy and
hysterectomy avoided) with
each of the other categorical
variables. The closer the
variable is to the illustrative
variable, means that there is
greater association

varying incidence according to the population and region
being studied. Differences in the demographic character-
istics are seen between our center and the local literature.
Patients treated in our institution tend to be older, with a
mean age of 31.6 years, similar to the ones reported in
England with a mean age of 33 years [15]. Multiparity
seems to be more in accordance with local statistics,
almost 52 % of multiparity compared to reports from other
places: London 45.4 % [15], Dublin 53 % [16], Pakistan
31 % [17], and 61.6 % in Bogotá, Colombia [18].
Caesarean section delivery has been associated with
PPH, presence of placenta previa and/or bleeding of the
placental bed. In our institution, caesarean section
delivery rates are higher than those seen in other centers
and because of its evident association with PPH,
obstetric hysterectomy rates are higher as well. This is a
clear indication to look for new ways to manage PPH in
a more conservative way with methods of easy
implementation that could be executed even by less
trained personnel, and that could offer satisfactory
results in scenarios such as those mentioned previously
in this article.
Even though our caesarean section and PPH rates are
higher than those seen in other places, our maternal mor-
tality rates related to obstetric hemorrhagic disorders is
0 % in contrast with most of the literature reported until
today. This is an encouraging result which is associated
with outstanding interdisciplinary work and resource
availability. Since 2006, our institution adopted a protocol
designed by the departments of anesthesiology and
obstetrics which not only includes the medical and surgical
staff but also different hospitalary personnel such as the
nursing staff and the transfusion and pharmacy services
among others. Since 2010 we have been using a LHA as
well in cases of placenta previa, placental accretism and
placental bed bleeding.

123

There has been a statistically significant rise in the
number of hysterectomies performed due to PPH despite
the introduction of new pharmacological agents and new
conservative surgical techniques. As an example, hospitals
in the U.K. have experienced a rise three times higher in
the last decade compared with the previous one. This
worldwide phenomenon has been partly attributed to the
rise in the ratio of caesarean sections performed. A cae-
sarean preceded 75 % of the emergency obstetric hyster-
ectomies described in the Yoong study [19]. Also previous
history of caesarean was associated with placenta previa
and placenta accreta in 38 % and 28 % of the cases
respectively [19]. A total of 45 emergency obstetric hys-
terectomies were performed in a review of 32,328 births, of
which 29.7 % were by caesarean, thus representing one in
2,526 vaginal deliveries and one in 267 caesarean deliv-
eries. The most frequently encountered pathology was
placenta accreta in 51.1 % of the cases, followed by pla-
centa previa in 26.7 % of the cases [20]. Kastenr et al., in a
study of 47 hysterectomized patients due to obstetric
emergency, found that 49.8 % had placenta accreta and
51.1 % had a previous history of caesarean [21]. Zelop
et al. found placenta accreta in 64 % of the cases, from
which 59.8 % had a previous record of caesarean [22]. It is
noteworthy to say that in all the cases of emergency
obstetric hysterectomy mentioned above, there was a
conservative unsuccessful medical and surgical approach
previous to the procedure. In patients with placenta accreta
and placenta previa the excessive bleeding comes from the
inferior uterine segment, which is morphologically and
functionally different from the upper segment. This could
explain the limited effect of traditional management in
PPH due to uterine hypotonia [23].
The use of LHAs has been reported in urologic [24],
neurologic [9], and cardiovascular surgery [7, 8] as well as
in other surgical fields. Nevertheless, its use in obstetrics is
rarely reported and the information we rely on is merely
based on case reports and case series [10, 11, 25]. Fuglsang
et al. reported what might be the largest series of cases with
15 patients who underwent caesarean section due to pla-
centa previa. They conclude that in patients with post cae-
sarean hemorrhage due to placenta previa the use of a LHA
on the bleeding surface is technically easy and suggest that
this procedure should be considered in these cases [13].
Beside these reports there is no evidence about the use of
SurgicelÒ FibrillarTM in the management of PPH. This LHA
is composed of a gauze with bioabsorbable oxidized
regenerated cellulose, its price per unit is approximately
$119.99 USD, no contraindications have been reported by
the manufacturer or in the medical literature, and in our
experience we have not seen any contraindications or
complications for its use in obstetric surgery [26]. Proposed
hemostatic mechanisms of action are lowering local pH
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Arch Gynecol Obstet
therefore acting as a caustic agent, generating an artificial
clot and possibly causing local vasoconstriction. Moreover
it has mechanical and physical plugging properties,
absorption of bleeding and gel formation. It also augments
the surface of interaction between platelets, collagen and
coagulation factors leading to coagulum organization.
Additionally, it has bactericidal properties against a wide
range of gram-positive and gram-negative bacteria.
In this study an inverse association was observed
between the use of SurgicelÒ FibrillarTM in patients with
PPH due to bleeding of the placental bed secondary to
placenta accreta or placenta previa and the need to perform
an emergency obstetric hysterectomy, use of hemoderiva-
tives and admission to the ICU as well as a significant
reduction in the mean duration of hospital stay. However,
limitations of our study include the fact that the non-LHA
group had higher parity and more twins vs. the LHA group,
and also the fact that the study involved a small sample size
and that it was not a randomized clinical trial and thus we
could not establish causality between exposure (SurgicelÒ
FibrillarTM) and outcomes. Nevertheless, due to the suc-
cessful results obtained by the use of this LHA in the
management of PPH in our institution, we do not consider
it ethically correct to perform a randomized clinical trial. In
consequence, according to the observed results we estab-
lished as a hypothesis the effectiveness and security of this
LHA for the management of PPH due to the aforemen-
tioned causes.
Therefore, it is important to highlight that those tech-
nically simple procedures such as the use of a LHA at the
bleeding site must be prioritized in cases of high pressure
and stress, like PPH, because they can be performed under
easy instructions and by less trained personnel. This work
opens new doors for future advances in the management of
PPH due to placentation defects.
Conflict of interest The authors state explicitly that there are no
conflicts of interest to be disclosed.
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