Comparative Study Between Oxytocin Versus Tranexamic Acid And Ethamsylate To Reduce Blood Loss Intra-operative And Postoperative During Elective Cesarean Section

INTRODUCTION

Abdominal Delivery is a procedural contribution to save the life’s of the fetus or the mother through incisions of the abdomen and lower uterine segment after viability.¹

It is frequently significant when the vaginal labour would situate the baby or the mother in danger.² this could be of obstructed vaginal labour, twins pregnancy, increased  vital marks of the mother, breech labour or problems with the placenta Or the umbilical cord and the pelvic area of the conceived woman or history of a previous C-delivery.²

The World Health Organization advocates that abdominal delivery should be performed only if medically obligatory.³ Some Cesarean Deliveries are

done by medically of non-cause which is revealed upon request by another one, oftenly the mother.²

Postpartum bleeding or After Delivery Bleeding is still a serious condition of maternal exhaustion and fatality world-widely corresponding to more or less 25% of dying of mothers directly.⁴ and reveals for fifty percent (50%) of women fatality in developing countries .⁵

Many plans of action were set to decrease the intra-operative blood loss, and ready to give help in reducing the hazards of blood transfer and therefore the post-procedure morbidity of the women .⁶

Drugs for example Sytocinon, Carbetocen, Mesoprostol, Prostaglandin-F2 alpha, and methylergonovin (methargine).were tested previously to adjust hemorrhage incidence through and after the Abdominal Delivery (RCOG 2016).⁷

Oxytocin: The Obstetricians and Gynecologists of the Royal College rules that the   abdominal delivery still emphasis about  injection of slow intravenous dose  of 5 IU from the oxytocin after fetal labour to urge contractions of the uterus, and hence, decrease intra-operative blood loss and thereby Postpartum Bleeding.⁷

Tranexamic acid (Kapron) seems to be an artificially made drug resemble  the structure of Lysine which is one of the  amino-acids . It works in a role of anti-fibrinolysis effect by reversible way, by attaching 4 to 5 lysine receptor sites on plasminogen. Furthermore suppresses the action of plasmin which has direct low capacity (IC50 = 87 mM).⁸ and it can prevents the effective location urokinase plasminogen activator (uPA) with higher selectivity (Ki = 2 mM) between all the serine proteases ( Wu G. et a.l, 2018).⁹

Etamsylate (Dicynon) this drug is a haemostatic agent its action depends on elevation the capillary endothelial resistancy  and motivating adherence(coherence) of the platelets.¹⁰ It likewise hinders bio-syntheses and activity on these prostaglandin products which as a reason for platelets separations, dilatation of the blood vessels and widened the permeability of the small vessels.¹¹ , It also facilitates platelet aggregation and adhesion which at last induce decrease and stop of hemorrhage.¹²

PATIENTS AND METHODS

This study was conducted between April and October 2020, on 200 conceived women attending to Sayed Galal Hospital, Al Azhar University and Shoubra General Hospital during the time of the study.

The study included conceived women either primigravidae or multigravidae submitted to elective Abdominal Delivery; estimatimation the loss of blood intra- operative and postoperatively in cases injected by Oxytocin versus Tranexamic acid combined with Ethamsylate.

The selected candidates were established into two collections:  the first  injected by Oxytocin  5 IU infusion on 500 cc saline 0.9% , at rate of 100cm/hour before the start of  the skin incision , and the second was injected by 1gram of  tranexamic acid and  250 mg of ethamsylate  IV slowly 5-10 minutes before the start of  the skin incision. Too.

Patients included in the study were aged from 20 to 40 years, delivered by Cesarean Delivery (LSCS) and Fetal Gestational age was 38 to 41 weeks. With suitable history, suitable general and local exams and accepted pregnant Doppler ultrasound and suitable laboratory results. Except the ones who had side effects to the medications prepared for this research, anaemic patients, polyhydraminos, multi fetal pregnancy, patients with fibroid uterus, patients with hemorrhagic tendency or coagulative abnormalities. And the conditions related to abnormal placentae. (Placental abnormalities).

As regard to the distribution of the candidates either primigravidae or multigravidae between both groups nearly equal distributed.

All the tested candidates were delivered by Elective abdominal delivery with suturing of the uterus into two layers inside the abdomen; spinal anesthesia was applied to all of them through the Lower Segment Cesarean Section utilized by a classic procedural approach and all the deliveries were done by one surgical team.

All participants were observed intra-operatively and post-operatively by close watching of the vital marks as blood pressure and heart rate, volume of urine inside the catheter and contractility of the uterus.

The chief aim results of this study was the amount of hemorrhage occurrence during the operation, and It was calculated by two variants, the primary mean was calculated by the variation between the weight of dry towels and the weight of wet towels with blood and any other liquids were suctioned out early before the usage of the towels. Another way, difference of the hemoglobin values before and after the procedure, also the Hematocrit percentage before the procedure and 24 hours later the procedure.

Secondary results were the percentage of participants whom progressed post-delivery bleeding and requirement for blood transfusion.

Statistical analysis:

IBM SPSS statistics (Statistical Package for Social Sciences) software version 22.0, IBM Corp., Chicago, USA, 2013 and Microsoft Office Excel 2007. Computer program was designed for accounting the sample size, the statistical calculator based on 95% of confidence interval and the power of the study is 80% with α- error 5. The level of significance was taken at P value < 0.050 is significant, otherwise is non-significant. Effect size was calculated to compare Tranexamic acid and ethamsylate group relatively to Oxytocin group using Mean±SE for quantitative variables and relative risk for qualitative variables.

RESULTS

From the measured variables of the participants of the trial demonstrated:

A-No remarkable variations among the studied candidates related to age, BMI, parity, gestational age and also indications of cesarean section.(Table 1)

Also in the study:

1-the operation time was non-significant between the two groups.

2-Intra-operative blood loss significantly decreased in the candidates received both Tranexamic acid and Ethamsylat than in the Oxytocin candidates.

3-No noted variations among the studied candidates in concerning to pre-procedure haemoglobin & hematocrit.

4-Post-procedure hemoglobin& hematocrit values was significantly higher in the group received both   Tranexamic acid and Ethamsylate than in the group of Oxytocin..

5-Haemoglobin & hematocrit reduction significantly lesser in the group of Tranexamic acid and Ethamsylate than in the group of Oxytocin.

6 – No statistically significance variations as regard to the Postoperative hospital stay duration in both groups. However it was lesser in the group of Tranexamic acid and Ethamsylate than in the group of Oxytocin . (Table 2)

And also, 1- The number of candidates received Blood transfusion were significantly fewer in the candidates received both Tranexamic acid and ethamsylate than in Oxytocin candidates.

2- No statistically significance variations as regard to Intra-operative adhesion, Postoperative fever and Postoperative infection in both groups, however it was lesser in the candidates received Oxytocin than in Tranexamic acid and ethamsylate candidates.

3- No statistically significant difference among all participants as regard to the incidence of Postpartum Hemorrhage.

4- It was obvious that the candidates who faced bleeding in the first group thorough the caesarean birth were 3 patients which represented 3%.  And 6 women bleeded during the operation in the second group which represented 6%. (Table 3)

Table 1: Demonstrates the specified components to all candidates as (Age, BMI, Parity, GA and Causes of Abdominal Delivery).

Table 2: Comparison regarding operation duration, blood loss, hemoglobin, hematocrit(pre and post operative) and postoperative hospital stay.