Introduction

Caesarean section (CS) rates have increased to 25 to 30% all over the world. Obstetric haemorrhage accounts for 20-25% of maternal mortality and morbidity. The most common complication of caesarean section is primary and secondary haemorrhage (20%). It leads to increase in maternal mortality and morbidity.1

The most significant challenge that an obstetrician faces during delivery is managing the placental separation that takes place during the third stage of labor. Myometrial contractions cause a significant constriction of blood vessels in the placental bed; however, adequate fibrin formation is also required for the process to be successful.

Because pregnancy is always represented as a hypercoagulable state, many physiological adaptations take place during pregnancy, and the hemostatic challenge is met in almost all pregnant women. During pregnancy, there is an increase in the concentration of many factors that contribute to blood clotting, including factors II, VII, VIII, IX, and XII. During pregnancy, a woman's body naturally produces fewer factors XI and XIII, which results in a lower concentration of clotting factors overall. This phenomenon is most prevalent in the third trimester of pregnancy.2

Tranexamic acid (TXA) is a synthetic lysine aminoacid derivative. It acts as an antifibrinolytic agent by blocking the lysine binding site on plasminogen molecules in a manner that is reversible. This reduces the rate at which hemostatic fibrin is dissolved by plasmin, which is the process that causes blood clots to break down.3 This results in the lysine receptors binding sites of plasmin for fibrin being well occupied by tranexamic acid, which prevents the binding of fibrin molecules and, as a result, preserves and stabilizes the fibrin matrix.4

Absorption following a single dose of oral administration, the peak concentration in plasma is reached in about three hours on average. On distribution, the plasma concentration of tranexamic acid is 30mg/L following an intravenous injection of 10mg/kg of tranexamic acid in pregnant women. Only a small portion of the drug is converted into its active form. The majority of it is flushed out of the body within the first ten hours, followed by other fractions.5 The half-life is approximately two hours. It has minimum side effects. Tranexamic acid is also used in various conditions like menorrhagia, Bleeding associated pregnancy, all gynecological procedures, traumatic hemorrhage and other surgical procedures.6

Hemorrhage that occurs during pregnancy is responsible for nearly 30 percent of all cases of maternal mortality. Clinicians continue to rely on visual estimates to determine the amount of postpartum blood loss, despite the fact, these estimates are frequently found to be inaccurate. Estimating the amount of blood lost during the postpartum period can be done using any one of a number of different methods. E.g.- Visual Assessment, Direct and standard measuring jar, Rubberized Blood Mat, Kelly’s Pad, Gravimetric method and Laboratory based methods.7, 8

When we fail to recognize the excessive blood loss that occurs during child birth, if early intervention is not initiated, obstetric hemorrhage can lead to death, which is the worst complication of pregnancy. The objective of this study was to study the effect of intravenous Tranexamic acid in reducing blood loss in patients undergoing Lower Segment Caesarean Section.9

Materials and Methods

This study was a Randomised Controlled Trial done in all the antenatal mothers aged >18yrs who underwent Caesarean section in the Department of Obstetrics and Gynaecology, in a tertiary care centre, Chengalpattu District, Tamil Nadu. This study was done in 50 antenatal patients who were satisfying the eligibility criteria after Institutional ethical committee approval number- 2021/662 was obtained.

Antenatal mothers >18yrs, Full term primigravida or Multigravida with singleton pregnancy undergoing Lower segment Caesarean section at Obstetrics and Gynaecology department were included and patient with Medical and surgical co-morbidities, History of thromboembolic disorders, complicated pregnancy, bleeding diathesis, those who are allergic to tranexamic acid, multiple pregnancy and polyhydramnios were excluded.

The patients were randomly categorized into Group A and Group B in the order of admission. All odd numbers were assigned in Group A and even numbers were assigned in Group B. Group A was considered as a study group and received 1gm intravenous tranexamic acid before incision and Group B was considered as a Control group who did not receive tranexamic acid before incision. Informed written consent was obtained from all the participants before proceeding.

Tranexamic acid was administered 15 to 20 minutes before incision in a dosage of one gram intravenously and slowly infused over 5-10 minutes, in addition to Oxytocin after the delivery of baby. Blood was collected into the suction container after the placental separation, thus excluding the collection of amniotic fluid into the suction container, so that the collected blood is only from that which has occurred after placental delivery.

All the soaked Gauge pads and operation table sheets were weighed before and after surgery. The measurement was done in two different periods. One from the time of placental separation to the end of surgery. The other from the end of surgery to two hours postpartum.

Quantity of blood loss = (weight of used material + weight of unused material) - (weight of all material prior to surgery) + volume collected in the suction container after placental delivery.

Evaluation of effectiveness of Tranexamic acid was given by:

Results

Among the study population, the mean difference of BMI was 26.4±2.75 in Group A and 27.52±3.07 in Group B, P value was 0. 181. The mean difference of Age among the study population was 25.68±3.86 in Group A and 24.96±3.83 in Group B, P value was 0.511. The mean difference of period of gestation between both the groups was 38.86±0.65 and 38.86±0.79 and P value was 0.999. Comparison of Socioeconomic status, place of living and occupation between the two groups was done. It was not statistically significant. P value >0.05 in our study.

Figure 1

Cluster bar chart of comparison of use of additional Oxytocin between group (N=50)

Among the study population, the difference in proportion of complication between study group was statistically significant. (p value <0.05).

Figure 2

Cluster bar chart of comparison of complication between group (N=50)

The difference in mean of bleeding from placental delivery to end of CS, end of CS to 2 hrs postpartum, total of both, Fall in Hb% (gm/dl) between study group was statistically significant. (p value <0.05).

Discussion

This was a randomized controlled trial conducted among the antenatal women aged > 18 years who had underwent lower segment caesarean section at the Department of Obstetrics and Gynaecology, Tertiary Care Centre, Nellikuppam, Ammapettai for about 18 months. One group received tranexamic acid while the other group did not. This was carried out to study the effect of intravenous low dose Tranexamic acid in blood loss reduction during caesarean section. Sample size was based on the article 11.10

Among the study population, the mean difference of BMI, Age, period of gestation between study group was not statistically significant. (p value >0.05). The mean age of the participants was 25 years. This was similarly supported by Gautam et al. where they found majority of the participants was around the age group of 26 years.11 We found that the mean gestational week of the women was 39 weeks. This was corroborated by Pirjani et al. where they observed the similar results.12

Conclusion

Tranexamic acid significantly reduces the amount of blood loss during and after lower segment caesarean section. It was not associated with any significant side effects and complications. It can be used effectively in all women undergoing caesarean section to reduce the postpartum Haemorrhage thereby reducing the maternal morbidity and mortality.

Source of Funding

None.

Conflict of Interest

None.