Estrid Staehr-Hansen

Katrine Fuglsang

Lone Kjeld Petersen

Margit Dueholm

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Hindawi Publishing Corporation
Journal of Pregnancy
Volume 2012, Article ID 635683, 4 pages
doi:10.1155/2012/635683
Clinical Study
Uterine Healing after Therapeutic Intrauterine
Administration of TachoSil (Hemostatic Fleece) in
Cesarean Section with Postpartum Hemorrhage
Caused by Placenta Previa
Katrine Fuglsang,1 Margit Dueholm,1 Estrid Stæhr-Hansen,2 and Lone Kjeld Petersen1
1 Department of Gynecology and Obstetrics, University Hospital of Aarhus, Skejby Sygehus, 8200 Aarhus N, Denmark
2 Institute of Pathology, University Hospital of Aarhus, Nørrebrogade, 8000 Aarhus C, Denmark
Correspondence should be addressed to Katrine Fuglsang, katrfugl@rm.dk
Received 4 January 2012; Accepted 1 March 2012
Academic Editor: Alexander Krafft
Copyright © 2012 Katrine Fuglsang et al. This is an open access article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly
cited.
Background. Application of hemostatic fleece (TachoSil) directly onto the bleeding surfaces of the lower uterine segment has
been used to obtain hemostasis during cesarean section caused by placenta previa. Methods. Eleven of 15 patients treated with
TachoSil for excessive postpartum haemorrhage due to placenta previa were enrolled. An evaluation of the cesarean section scar
by transvaginal ultrasound, the uterine cavity and endometrium by hysteroscopy, and the endometrium by biopsy were made.
The main outcome measures were intrauterine adhesions, recovery of endometrium at the site of TachoSil application, visible
remnants of TachoSil, and scar healing. Results. Eight patients had small remnants of TachoSil in the uterine cavity together with
signs of resorption. All had a normal endometrial mucosa, and none had adhesions in the uterine cavity. All cesarean section scars
were healed without defects. Conclusion. TachoSil did not seem to impair healing of the endometrium or scar formation in the
uterus after intrauterine application. Resorption of TachoSil seems to progress individually. Intrauterine treatment with TachoSil
is a valuable supplement to the traditional treatment of post partum haemorrhage and may help retain reproductive capability.
This is a small study, and it will require more studies to confirm the reproducibility.
1. Introduction
The incidence of postpartum hysterectomy varies from 0.2
to 1.74/1000 deliveries. The most common indication for
postpartum hysterectomy is abnormally adherent placenta
(59%), 41% of which are due to placenta previa [1].
Delivery of patients with placenta previa is associated with
the risk of excessive bleeding. Hysterectomy is a lifesaving
procedure in the treatment of excessive bleeding due to
placenta previa, but it deprives the woman of her ability for
further reproduction [2]. In patients with placenta previa,
traditionally methods, such as uterotonics, for reducing the
blood loss [3] may be insufficient probably because of less
muscular activity in the lower uterine segment [4]. Other
methods are needed as alternatives to hysterectomy.
Application of TachoSil in the peritoneal cavity is a well-
documented treatment, and studies show that the fleece
is absorbed [5, 6]. Intrauterine treatment with TachoSil
is a new technique with obvious short-term benefits to
the patients, but its potential effects on uterine heeling
are unknown, and insufficient healing and adhesions could
impair the menstrual flow and decrease the ability to achieve
future pregnancy. Moreover, the resorption of TachoSil in the
uterine cavity is unknown.
The purpose of this study was to evaluate the potential
side effects of the application of TachoSil in the uterine cavity.
2 Journal of Pregnancy
We studied the healing of cesarean section scars, resorption
of TachoSil, recovery of the endometrium at the site of
TachoSil and formation of adhesion in the uterine cavity.
In this study, TachoSil was applied when the surgeon
assessed the haemorrhage to be unacceptable despite utero-
tonics. We noted a trend toward faster use of TachoSil from
the first patient to the last patient. Thus blood loss and
the use of uterotonics and operative procedures to control
haemorrhage were reduced [7].
2. Materials and Methods
Fifteen patients treated with TachoSil for excessive postpar-
tum haemorrhage due to placenta previa in the period from
January 1, 2007, to January 31, 2009, at the Department of
Gynecology and Obstetrics, University Hospital of Aarhus,
Skejby Sygehus, were invited for follow-up.
All had been diagnosed with partial or total placenta
previa via ultrasound examination in gestational week 32.
During their cesarean section, whether acute or elective,
traditional uterotonics could not control the bleeding and
the surgeon applied TachoSil, after which the hemorrhage
was controlled.
The fifteen patients were offered an intrauterine exami-
nation and a check of their past gynecologic history. We were
able to contact all 15: 11 agreed to participate and 3 declined
because of ongoing pregnancy. The patients underwent
a transvaginal ultrasound examination performed on a
Voluson E8 Expert BT06 with a 12 MHz 3D/4D transvagi-
nal transducer (GE Healthcare, USA). We evaluated the
thickness of the endometrium, healing of the cesarean scar
with presence of large uterine scars (<2.5 mm of remaining
myometrium), and evidence of any remnants of the TachoSil.
Hysteroscopy was performed with saline for distension and
a 5 mm continuous flow office mini-hysteroscope (Bettoc-
chi office hysteroscope, Karl Storz, Tuttlingen, Germany).
Cervical canal, intrauterine cesarean section scar healing,
and the endometrial mucus membrane were evaluated.
Any remnants of the TachoSil and/or agglutination in the
uterine cavity were also described. During the hysteroscopy,
biopsies were obtained with a grasping forceps from the
endometrium covering the lower uterine segment. One in-
vestigator with more than 10 years experience in ultrasound
and hysteroscopy did all the examinations.
Two years after the clinical evaluation, a review of the 15
patients’ hospital records was made to evaluate their number
of pregnancies after treatment with TachoSil.
3. Results
Eleven patients participated in the study, and none experi-
enced complications. Their mean age at delivery was 33.6
years (range 29–41). The mean time from the cesarean sec-
tion to the examination was 11 months (range 5–25).
There was an individual variation in the length of menos-
tasia (1–8 months), but all had resumed menstruation
(Table 1).
Six were primigravida and had not undergone any oper-
ative gynecological procedures. Five women had a history of
Figure 1: Intrauterine remnant of TachoSil (hemostatic fleece) vis-
ualized by hysteroscopy.
previosly cesarean section. In this group the mean number
of pregnancies was 3.6 (range 2–6) and the mean number
of cesarean sections was 2.6 (range 2–4). One patient had a
previous D&C, and one patient had been operated on twice
for ectopic pregnancy.
The ultrasound examinations visualized the incisional
area after cesarean section in the anterior wall of the myome-
trium in all patients. The endometrium was described as thin
at this location compared to the rest of the uterine cavity. In
five of the patients, an echogenic density (punctate to 4 mm
in diameter) gave the impression of a TachoSil remnant. In
these patients, the mean time from cesarean section to the
examination was 9.4 months (range 7–13) (Table 1).
The hysteroscopy showed covering of the endometrium
in the lower segment in all patients, and no adhesions were
seen in the uterine cavity. In eight of the patients, TachoSil
remnants were found (Figure 1). The size was described from
punctate to 1.5 cm, and the size range was not consistent with
the time from cesarean section to the examination (Table 1).
If TachoSil remnants were found during the hysteroscopy,
a biopsy was taken from this area, but otherwise random
biopsies were taken. Unfortunately the biopsies were not
useful for diagnostic purposes due to the size of the sample
provided by the office hysteroscope.
Six of the fifteen have spontaneously become pregnant
(Table 1). Five have delivered at term and one is pregnant in
gestational week 20 (Table 2).
4. Discussion
Application of TachoSil at the lower intrauterine segment
at cesarean section did not compromise the healing of the
uterine scar or regeneration of the normal endometrium in
the uterine cavity as evaluated by ultrasound or hysteroscopy.
Application of TachoSil is a simple, efficient, and rapid-
onset treatment, giving control of bleeding. Consequently,
none of the patients given TachoSil needed reoperation
or developed post-partum endometritis [7]. Application of
TachoSil to the lower segment does not give rise to formation
of adhesions in the uterine cavity. Six patients became
pregnant spontaneously, and all study patients examined had
Journal of Pregnancy 3
Table 1: Results of clinical control and overview of pregnancies after treatment with TachoSil application in the uterine cavity.
PatientPregnancy Cesarean section Age
Menostasia Time since delivery Ultrasound Hysteroscopy Pathology
Montha Month Scar TachoSil (mm) TachoSil (mm) Endometrium TachoSil
No pregnancy after application of TachoSil in the uterine cavity
2 6 2 41 Mens 25 Visible no no
5 2 1 38 3 13 Visible
yes yes
2× 1 punctual
6 4 3 32 Mens 13 Visible no
yes 0
no no
15× 1
9 2 1 37 Mens 7 Visible
yes yes
3× 3 3× 3
10 1 0 34 6 7 Visible
yes yes
yes no
4× 2 4× 2
12 1 0 31 1 9 Visible
yes yes
yes yes
punctuate punctuate
15 4 1 29 Mens 5 Visible no
yes 0
yes yes
10× 1
Pregnancy after application of TachoSil in the uterine cavity
3 1 0 31 †
4 1 0 35 8 19 Visible no no yes yes
7 1 0 31 2 9 Visible no no
8 1 0 30 1 11 Visible
yes yes
yes yes
3× 3 3× 3
11 1 0 32 3 6 Visible no yes punctuate yes no
13 1 0 31 †
a
Mens: menstruation was regained approximately two to three months postpartum, but they did not remember the exact time interval for menostasia.
†Did not attend the clinical control due to pregnancy.
Table 2: Outcome of pregnancies two years after clinical control.
Patient Pregnancy Outcome
3 1 Spontaneous vaginal delivery at term
4 1 Spontaneous vaginal delivery at term
7 1 Cesarean section at term due to previosly cesarean section with placenta accreta and previa
8 1 Cesarean section at gestational week 41+5
11 1 Spontaneous vaginal delivery at term
13 3
Abortus inhibitus
Abortus provocatus
Ongoing pregnancy in gestational week 20
resumed menstruation and showed no signs of adhesion on
hysteroscopy.
Delivery of patients with placenta previa may be difficult,
and the associated risk of excessive bleeding can cause
maternal death [8].
Using TachoSil to reduce the volume of haemorrhage
during cesarean section due to placenta previa has demon-
strated potential benefits. Thus this new method may control
the heavy bleeding and save life without dramatic conse-
quences for the woman giving birth. Therefore it seemed
rational to introduce the procedure of applying TachoSil to
the lower uterine segment in the presence of uncontrolled
hemorrhage in spite of given uterotonics and before B-lynch
suture or ligation of internal illiac artery was performed [7].
TachoSil consists of equine collagen, human thrombin,
and fibrinogen. TachoComb, a predecessor to this product, is
very similar, consisting of equine collagen, bovine thrombin,
human fibrinogen, and bovine aprotinin. It is degraded
intraperitoneally within 12 weeks in the majority of patients
[5]. In a rabbit model, administration of TachoComb
prevents adhesions compared to no treatment after operative
procedures. Furthermore, histological investigations reveal
that the outer surface of the applied TachoComb patch was
completely covered by a new serosal layer 2 weeks after
4 Journal of Pregnancy
the operation [6]. These studies support the intrauterine
appliance of TachoSil to avoid postpartum hysterectomy and
preserve a woman’s ability to become pregnant.
However, more studies are needed on the effect of
TachoSil application in the uterine cavity; especially needed
is an evaluation of the use of TachoSil in the corpus of the
uterine cavity for placenta site bleeding after childbirth.
In four patients, there were no visible remnants of the
TachoSil. In eight of the patients traces of TachoSil were
found in the uterine cavity. Based on visual impression there
were no endometrial reactions or signs of inflammation
related to these remnants. The size of the TachoSil swab
applied was 3.0 × 2.5 cm. Remnants varied from punctate to
1.5 × 1 cm, but our impression was that TachoSil was in the
process of being resorbed in all patients. The largest remnant
was found in patient 6, although TachoSil had been applied
13 months previously, confirming the individual variation in
the time of resorption. The cesarean sectional scar healed
without large scar defects. TachoSil has been used for the
sealing of anastomoses [9] and in hernia repair [10], and, as
evidenced by other studies, it does not seem to compromise
scar formation.
5. Conclusion
Application of TachoSil to the lower uterine segment is an
efficient haemostatic procedure to control excessive haem-
orrhage due to placenta previa. Technically the procedure
is an easy and safe procedure and can be performed in all
surgical wards. We did not find endothelial defects at the
site of TachoSil application or the formation of adhesions in
the uterine cavity. The fact that six of the patients became
pregnant spontaneously supports this theory. Even though
we found TachoSil remnants in eight of the patients, the
size of these remnants supports the fact that the speed of
resorption varies from patient to patient. Furthermore, this
variation had no consequence for the women’s reproductive
ability, because all had resumed menstruation.
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Clinical Study Uterine Healing after Therapeutic Intrauterine Administration of TachoSil (Hemostatic Fleece) in Cesarean Section with Postpartum Hemorrhage Caused by Placenta Previa

http://citeseerx.ist.psu.edu/viewdoc/download;jsessionid=163AB9ACB82C5EC6510585BC14D5930F?doi=10.1.1.1074.882&rep=rep1&type=pdf

Clinical Study Uterine Healing after Therapeutic Intrauterine Administration of TachoSil (Hemostatic Fleece) in Cesarean Section with Postpartum Hemorrhage Caused by Placenta Previa

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