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‫ع‬
‫ا‬‫م‬‫لا‬‫ا‬‫ا‬‫ن‬‫ل‬‫م‬‫ل‬‫ع‬
‫لا‬‫ك‬‫ن‬‫ا‬‫ح‬‫ب‬‫س‬‫وا‬‫ل‬‫ا‬‫ق‬‫ا‬‫ن‬‫ت‬‫م‬‫ل‬
‫ك‬‫ن‬‫ا‬‫م‬‫ي‬‫ل‬‫ع‬‫ل‬‫ا‬
‫ت‬‫ن‬‫ا‬‫م‬‫ي‬‫ك‬‫ح‬‫ل‬‫ا‬
‫البقرة‬ ‫العظيم‬ ‫هللا‬‫صدق‬32
‫الرحيم‬ ‫الرحمن‬ ‫هللا‬ ‫بسم‬
EFFICACY OF INTRAVENOUS
TRANEXAMIC ACID IN REDUCING
BLOOD LOSS DURING ELECTIVE
CESAREAN SECTION
INTRODUCTION
Cesarean section rates have increased to as high
as 25 – 30% in many areas of the world, In United States
cesarean section rate reached 31.3% , the CS rate is
25.5% in United Kingdom. In 2008 EDHS reported that
more than 25% of deliveries were by CS.
The average blood loss during cesarean delivery (1000 mL) is
double the amount lost during vaginal delivery (500 mL). The
hematocrit falls by 10% and blood transfusion is required in 6%
of women undergoing cesarean delivery.
In severe cases , CS may result in major
obstetric hemorrhage, hysterectomy, admission to
an intensive care unit, or maternal death.
Medications, such as oxytocin, misoprostol,
prostaglandin F2α, and methyl ergonovine, have
been used to control bleeding after CS.
Obstetric hemorrhage remains one of the major
determinants of maternal death in both developed
and developing countries.
Reducing intrapartum and postpartum bleeding in
both cesarean section and vaginal delivery patients is
very important to reduce the rates of maternal mortality
and morbidity.
Tranexamic acid (TXA), a synthetic derivate of the
amino acid lysine, is an antifibrinolytic that reversibly
inhibits the activation of plasminogen, thus inhibiting
fibrinolysis and reducing bleeding.
TXA has been used to reduce blood loss and the
need for blood transfusion in cardiac surgery, liver
transplantation, and orthopedic surgical procedures.
Furthermore, TXA decreases the risk of death in
bleeding trauma patients
In gynecology and obstetrics, TXA is most commonly used
to treat idiopathic menorrhagia . Bleeding associated
with pregnancy (placental abruption, placenta previa)
has also been treated with TXA.
AIM OF THE WORK
Aim of the work was to:
Reach the minimal blood loss during elective
cesarean section in order to decrease patients'
morbidity by using Tranexamic acid injection
before operation time .
PATIENTS AND METHODS
The following study was conducted at Zagazig University
Hospitals and El Mataria Teaching Hospital.
A non-randomized controlled study was carried out
over a period of eight months from December 2014 to July
2015.
220 women attending to labor ward for elective
cesarean section- were recruited in our study to be divided
into two groups.
 Group1 (The study Group) consisted of 110 pregnant
females who were subjected to:
1 gm TXA was administered by slow IV inj. 10 min.
before skin incision . After delivery of the neonate, 10
units of oxytocin were administered by IV drip.
 Group 2 (The control group) consisted of 110 pregnant
females who were subjected to:
10 ml. normal saline solution were administered by slow
IV inj. 10 min. before skin incision .Oxytocin was given as
in study group.
Inclusion Criteria:
Pregnant women with singleton living fetus.
 Completed 37 weeks gestational age or above.
Exclusion criteria:
 Severe medical and surgical complications involving the
heart, liver or kidney, brain disease and blood disorders.
 Bleeding tendency.
 Known allergy to tranexamic acid.
 History of thrombo-embolic disorders.
 pregnancy complications, such as preeclampsia.
 Abnormally situated placenta(previously detected by U/S).
 Ante-partum hemorrhage.
 Multiple pregnancies, Fetal macrosomia, polyhydramnios.
 Fetal distress.
All patients were subjected to:
Informed consent: obtained from the patients.
Full History taking: including Full personal history and medical
history of present pregnancy with baseline data of maternal
age , Parity & Estimated gestational age.
Clinical observation :
Vital signs: HR,RR&BP were checked before cesarean section
and immediately after placental delivery, one and two hours
after birth, respectively.
Maternal side effects caused by TXA such as GIT upsets, visual
disturbances, itching, symptoms and signs indicating
thrombosis.
Need for other surgical measures to stop bleeding.
Operative procedures:
All patients underwent elective CS under spinal anaesthesia.
Laboratory Investigations:
Complete blood count (CBC) was performed before delivery and
24 hours after cesarean section .
Estimated blood loss by equation using haematocrit levels .
Estimated blood loss
where EBV (estimated blood volume) in mL=the woman’s weight in
kg×85.
Evaluation of the efficacy and safety of TXA in CS:
Efficacy:
1. Measuring the quantity of blood loss.
2. The incidence of postpartum hemorrhage was observed.
Safety:
1. Vital signs monitoring.
2. General and local reactions caused by TXA were guarded .
RESULTS
Demographic data in both groups
Characteristics
Control
group
Tranexamic
acid group
t/X2 P
N % N %
Age
<30
>30
Mean ±SD
83
27
75.5
24.5
82
28
74.5
25.5
0.024 0.86
27.8±4.98 27.36±5.9 0.605 0.546
Parity Multipara 98 89.1 93 84.5
0.99 0.31PG 12 10.9 17 15.5
Graphic representation of Age distribution
0
10
20
30
40
50
60
70
80
90
control group Tranexamic acid
group
83 82
27 28
below 30 years
more than 30 years
Graphic representation of Parity distribution
0
10
20
30
40
50
60
70
80
90
100
control group Tranexamic acid group
12
17
98
93
PG
Multipara
comparison between control and TXA group regard
GA and weight of pt. before CS.
Characteristics
Control group
N=110
Tranexamic acid
group
N=110
t P
Gestational age
(GA) in (wks.)
38.5±0.9 38.53±1.57 -0.210 0.834
Weight (kg.) 75.84±6.04 76.8±5.3 -1.299 0.195
comparison between control and TXA group as
regard heart rate(HR) before, during, 1 hour and 2
hours after CS.
Characteristics
Control group
N=110
Tranexamic acid
group
N=110
t P
HR pre operative
(B/min.) 84.12±4.4 84.49±3.5 -0.673 0.501
HR during
operation(B/min.) 88.09±11.5 90.87±3.59 -2.407 0.017*
HR 1 hour post
operative(B/min.) 83.99±4.3 81.93±3.5 3.824 0.00**
HR 2 hour post
operative(B/min.) 85.0±3.7 85.03±8.06 -0.043 0.966
comparison between both groups as regard SBP
and DBP before, during, 1 hour and 2 hours after CS.
Characteristics
Control group
N=110
TXA group
N=110
t P
SBP pre operative (mmHg) 113.5±9.3 114.5±6.9 -0.904 0.367
DPB pre operative
(mmHg)
74.17±7.5 73.87±6.3 1.731 0.092
SBP during operation(mmHg) 109.72±8.1 108.95±5.8 0.715 0.476
DBP during operation(mmHg) 69.87±9.8 68.54±8.2 1.881 0.071
SBP 1 hour post operative(mmHg)
115.74±8.55 114.77±6.88 0.929 0.354
DBP 1 hour post operative(mmHg)
78.1±8.7 75.95±9.51 2.536 0.01*
SBP 2 hour post operative(mmHg)
109.81±7.61 110.25±4.4 -1.736- 0.091
DBP 2 hour post operative(mmHg)
72.19±7.5 72.22±6.3 -0.039- 0.969
Comparison between both groups with regard RR .
Characteristics
Control group
N=110
Tranexamic acid
group
N=110
t P
RR pre Operative
(Cycle/min.)
18.84±3.4 18.82±3.1 -0.954 0.221
RR during Operation
(Cycle/min.)
22.2±1.49 21.3±1.3 5.452 0.00**
RR 1hour post Operative
(Cycle/min.)
18.98±1.3 17.83±0.69 8.046 0.00**
RR 2hour post Operative
(Cycle/min.)
18.07±1.18 17.17±0.58 7.128 0.00**
comparison between both groups as regard
hematocrit difference, blood loss and Hematocrit
CS.value pre and post
Characteristics
Control group
N=110
Tranexamic acid group
N=110
t P
Hematocrit
pre_operative (%)
37.18±1.59 36.88±1.69 1.62 0.110
Hematocrit
post _operative (%)
32.63±1.7 33.48±1.72 -2.788 0.006*
Hematocrit difference
(%) 4.49±0.78 3.44±0.97 5.311 0.00**
BLOOD LOSS (ml.) 773.79±141.7 647.93±155.0 6.284 0.00**
Comparison of Surgical Outcomes between Groups
Characteristics
control Group
(n=110)
Tranexamic Acid
Group (n=110)
X2 P
Blood loss >1000 mL (n, %) 9 (8.2%) 2 (1.8%) 4.689 0.03*
Blood transfusion (n, %) 2(1.8%) 1(0.9%) 0.3 0.58
Additional uterotonic agent (n, %) 12 (10.9%) 10 (9.09%) 0.164 0.684
Thromboembolic events (n, %)
1. Deep venous thrombosis
2. Myocardial infarction
3. Stroke
4. Renal failure
5. Pulmonary embolism
-
-
-
-
-
-
-
-
-
-
- -
Graphic representation of the number of women
who experienced PPH in both groups
no.
TOTAL
study group
controlgroup
2 9
110 110
Estimated blood loss >1000mL
no.
TOTAL
CONCLUSION
:We concluded that
 TXA is effective in reducing the amount of blood loss
during and after CS .
 TXA decrease the percentage of patients with blood loss
>1000 mL.
 Additionally, no increase in the incidence of
thromboembolic events was observed. Also, Its use is not
associated with increased risk of mild adverse drug
reactions like nausea, vomiting or diarrhoea.
Cont….
 Although this study is not the first of its kind on this
matter however, it confirms the effectiveness
and safety of TXA in reducing bleeding in
elective CS.
RECOMMENDATIONS
:We recommend that
 Tranexamic acid is valuable and significantly
reduces the quantity of blood loss during and after
CS but further studies are needed to exclude any
short or long term effects on the mother or the fetus.
 The limitations of the study include a small sample
size. So, we recommend further studies involving
larger sample size to realize the incidence of
occurrence of side effects caused by TXA .
Cont….
 Further studies should include anemic
women and those having a risk for PPH. In
these groups, TXA may be more
beneficial.
Thank You

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Role of tranexamic acid in cesarean section

  • 2. EFFICACY OF INTRAVENOUS TRANEXAMIC ACID IN REDUCING BLOOD LOSS DURING ELECTIVE CESAREAN SECTION
  • 4. Cesarean section rates have increased to as high as 25 – 30% in many areas of the world, In United States cesarean section rate reached 31.3% , the CS rate is 25.5% in United Kingdom. In 2008 EDHS reported that more than 25% of deliveries were by CS. The average blood loss during cesarean delivery (1000 mL) is double the amount lost during vaginal delivery (500 mL). The hematocrit falls by 10% and blood transfusion is required in 6% of women undergoing cesarean delivery.
  • 5. In severe cases , CS may result in major obstetric hemorrhage, hysterectomy, admission to an intensive care unit, or maternal death. Medications, such as oxytocin, misoprostol, prostaglandin F2α, and methyl ergonovine, have been used to control bleeding after CS. Obstetric hemorrhage remains one of the major determinants of maternal death in both developed and developing countries.
  • 6. Reducing intrapartum and postpartum bleeding in both cesarean section and vaginal delivery patients is very important to reduce the rates of maternal mortality and morbidity. Tranexamic acid (TXA), a synthetic derivate of the amino acid lysine, is an antifibrinolytic that reversibly inhibits the activation of plasminogen, thus inhibiting fibrinolysis and reducing bleeding.
  • 7. TXA has been used to reduce blood loss and the need for blood transfusion in cardiac surgery, liver transplantation, and orthopedic surgical procedures. Furthermore, TXA decreases the risk of death in bleeding trauma patients In gynecology and obstetrics, TXA is most commonly used to treat idiopathic menorrhagia . Bleeding associated with pregnancy (placental abruption, placenta previa) has also been treated with TXA.
  • 8. AIM OF THE WORK
  • 9. Aim of the work was to: Reach the minimal blood loss during elective cesarean section in order to decrease patients' morbidity by using Tranexamic acid injection before operation time .
  • 11. The following study was conducted at Zagazig University Hospitals and El Mataria Teaching Hospital. A non-randomized controlled study was carried out over a period of eight months from December 2014 to July 2015. 220 women attending to labor ward for elective cesarean section- were recruited in our study to be divided into two groups.
  • 12.  Group1 (The study Group) consisted of 110 pregnant females who were subjected to: 1 gm TXA was administered by slow IV inj. 10 min. before skin incision . After delivery of the neonate, 10 units of oxytocin were administered by IV drip.  Group 2 (The control group) consisted of 110 pregnant females who were subjected to: 10 ml. normal saline solution were administered by slow IV inj. 10 min. before skin incision .Oxytocin was given as in study group.
  • 13. Inclusion Criteria: Pregnant women with singleton living fetus.  Completed 37 weeks gestational age or above.
  • 14. Exclusion criteria:  Severe medical and surgical complications involving the heart, liver or kidney, brain disease and blood disorders.  Bleeding tendency.  Known allergy to tranexamic acid.  History of thrombo-embolic disorders.  pregnancy complications, such as preeclampsia.  Abnormally situated placenta(previously detected by U/S).  Ante-partum hemorrhage.  Multiple pregnancies, Fetal macrosomia, polyhydramnios.  Fetal distress.
  • 15. All patients were subjected to: Informed consent: obtained from the patients. Full History taking: including Full personal history and medical history of present pregnancy with baseline data of maternal age , Parity & Estimated gestational age. Clinical observation : Vital signs: HR,RR&BP were checked before cesarean section and immediately after placental delivery, one and two hours after birth, respectively. Maternal side effects caused by TXA such as GIT upsets, visual disturbances, itching, symptoms and signs indicating thrombosis. Need for other surgical measures to stop bleeding.
  • 16. Operative procedures: All patients underwent elective CS under spinal anaesthesia. Laboratory Investigations: Complete blood count (CBC) was performed before delivery and 24 hours after cesarean section . Estimated blood loss by equation using haematocrit levels . Estimated blood loss where EBV (estimated blood volume) in mL=the woman’s weight in kg×85.
  • 17. Evaluation of the efficacy and safety of TXA in CS: Efficacy: 1. Measuring the quantity of blood loss. 2. The incidence of postpartum hemorrhage was observed. Safety: 1. Vital signs monitoring. 2. General and local reactions caused by TXA were guarded .
  • 19. Demographic data in both groups Characteristics Control group Tranexamic acid group t/X2 P N % N % Age <30 >30 Mean ±SD 83 27 75.5 24.5 82 28 74.5 25.5 0.024 0.86 27.8±4.98 27.36±5.9 0.605 0.546 Parity Multipara 98 89.1 93 84.5 0.99 0.31PG 12 10.9 17 15.5
  • 20. Graphic representation of Age distribution 0 10 20 30 40 50 60 70 80 90 control group Tranexamic acid group 83 82 27 28 below 30 years more than 30 years
  • 21. Graphic representation of Parity distribution 0 10 20 30 40 50 60 70 80 90 100 control group Tranexamic acid group 12 17 98 93 PG Multipara
  • 22. comparison between control and TXA group regard GA and weight of pt. before CS. Characteristics Control group N=110 Tranexamic acid group N=110 t P Gestational age (GA) in (wks.) 38.5±0.9 38.53±1.57 -0.210 0.834 Weight (kg.) 75.84±6.04 76.8±5.3 -1.299 0.195
  • 23. comparison between control and TXA group as regard heart rate(HR) before, during, 1 hour and 2 hours after CS. Characteristics Control group N=110 Tranexamic acid group N=110 t P HR pre operative (B/min.) 84.12±4.4 84.49±3.5 -0.673 0.501 HR during operation(B/min.) 88.09±11.5 90.87±3.59 -2.407 0.017* HR 1 hour post operative(B/min.) 83.99±4.3 81.93±3.5 3.824 0.00** HR 2 hour post operative(B/min.) 85.0±3.7 85.03±8.06 -0.043 0.966
  • 24. comparison between both groups as regard SBP and DBP before, during, 1 hour and 2 hours after CS. Characteristics Control group N=110 TXA group N=110 t P SBP pre operative (mmHg) 113.5±9.3 114.5±6.9 -0.904 0.367 DPB pre operative (mmHg) 74.17±7.5 73.87±6.3 1.731 0.092 SBP during operation(mmHg) 109.72±8.1 108.95±5.8 0.715 0.476 DBP during operation(mmHg) 69.87±9.8 68.54±8.2 1.881 0.071 SBP 1 hour post operative(mmHg) 115.74±8.55 114.77±6.88 0.929 0.354 DBP 1 hour post operative(mmHg) 78.1±8.7 75.95±9.51 2.536 0.01* SBP 2 hour post operative(mmHg) 109.81±7.61 110.25±4.4 -1.736- 0.091 DBP 2 hour post operative(mmHg) 72.19±7.5 72.22±6.3 -0.039- 0.969
  • 25. Comparison between both groups with regard RR . Characteristics Control group N=110 Tranexamic acid group N=110 t P RR pre Operative (Cycle/min.) 18.84±3.4 18.82±3.1 -0.954 0.221 RR during Operation (Cycle/min.) 22.2±1.49 21.3±1.3 5.452 0.00** RR 1hour post Operative (Cycle/min.) 18.98±1.3 17.83±0.69 8.046 0.00** RR 2hour post Operative (Cycle/min.) 18.07±1.18 17.17±0.58 7.128 0.00**
  • 26. comparison between both groups as regard hematocrit difference, blood loss and Hematocrit CS.value pre and post Characteristics Control group N=110 Tranexamic acid group N=110 t P Hematocrit pre_operative (%) 37.18±1.59 36.88±1.69 1.62 0.110 Hematocrit post _operative (%) 32.63±1.7 33.48±1.72 -2.788 0.006* Hematocrit difference (%) 4.49±0.78 3.44±0.97 5.311 0.00** BLOOD LOSS (ml.) 773.79±141.7 647.93±155.0 6.284 0.00**
  • 27. Comparison of Surgical Outcomes between Groups Characteristics control Group (n=110) Tranexamic Acid Group (n=110) X2 P Blood loss >1000 mL (n, %) 9 (8.2%) 2 (1.8%) 4.689 0.03* Blood transfusion (n, %) 2(1.8%) 1(0.9%) 0.3 0.58 Additional uterotonic agent (n, %) 12 (10.9%) 10 (9.09%) 0.164 0.684 Thromboembolic events (n, %) 1. Deep venous thrombosis 2. Myocardial infarction 3. Stroke 4. Renal failure 5. Pulmonary embolism - - - - - - - - - - - -
  • 28. Graphic representation of the number of women who experienced PPH in both groups no. TOTAL study group controlgroup 2 9 110 110 Estimated blood loss >1000mL no. TOTAL
  • 30. :We concluded that  TXA is effective in reducing the amount of blood loss during and after CS .  TXA decrease the percentage of patients with blood loss >1000 mL.  Additionally, no increase in the incidence of thromboembolic events was observed. Also, Its use is not associated with increased risk of mild adverse drug reactions like nausea, vomiting or diarrhoea.
  • 31. Cont….  Although this study is not the first of its kind on this matter however, it confirms the effectiveness and safety of TXA in reducing bleeding in elective CS.
  • 33. :We recommend that  Tranexamic acid is valuable and significantly reduces the quantity of blood loss during and after CS but further studies are needed to exclude any short or long term effects on the mother or the fetus.  The limitations of the study include a small sample size. So, we recommend further studies involving larger sample size to realize the incidence of occurrence of side effects caused by TXA .
  • 34. Cont….  Further studies should include anemic women and those having a risk for PPH. In these groups, TXA may be more beneficial.