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الحكيم 32صدق الله العظيم البقرة

بسم الله الرحمن الرحيم

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

8327

75.524.5

8228

74.525.5

0.024

0.86

27.8±4.98 27.36±5.9 0.605

0.546

Parity Multipara 98 89.1 93 84.50.99 0.3

1PG 12 10.9 17 15.5

Graphic representation of Age distribution

control group Tranexamic acid group

0

10

20

30

40

50

60

70

80

90 83 82

27 28

below 30 yearsmore than 30 years

Graphic representation of Parity distribution

control group Tranexamic acid group0

10

20

30

40

50

60

70

80

90

100

12 17

98 93

PGMultipara

comparison between control and TXA group regard GA and weight of pt. before CS.

Characteristics

Control groupN=110

Tranexamic acid groupN=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.

CharacteristicsControl 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 groupN=110

Tranexamic acid groupN=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

Characteristicscontrol 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

study groupcontrolgroup no.

TOTAL

2 9

110 110Estimated 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 thatTranexamic 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