Comparison of intravenous tranexamic acid versus sublingual misoprostol in reducing blood loss in patients undergoing caesarean section-an analytical observational study

Abstract

Background: Preventing postpartum haemorrhage using uterotonics or other antifibrinolytic drugs is need of the hour among women undergoing caesarean section (CS). This study is to compare the effectiveness of intravenous Tranexamic acid versus sublingual misoprostol in reducing blood loss by assessing intraoperative and postoperative blood loss in patients undergoing CS. Methods: Analytical observational study was conducted in department of obstetrics and gynaecology at sri Devaraj URS medical college, among 118 pregnant women admitted for CS. Study was conducted between January 2020 to June 2021. The sample was divided equally into intravenous tranexamic acid and sublingual misoprostol groups. Number of mops, pads soaked, suction volume excluding the amniotic fluid, preoperative and post-operative haemoglobin, any complication were recorded. Results: The mean of mops counts in the misoprostol, TXA group were noted as 4.73±1.27, 3.2±1.45 respectively. Around 8.47% of the participants in the misoprostol group required uterotonics, whereas, 15.25% in the TXA group required uterotonics. The preoperative and postoperative haemoglobin in misoprostol group were identified as 11.67±1.37, 10.78±1.12 respectively, whereas it was identified as 11.76±1.43, 11.17±1.4 in TXA group. The common side effects identified in the misoprostol group was chills, vomiting and fever with 47.46%, 13.56% and 11.86% while, it was 11.86%, 5.08% and 3.39% in the TXA group. Conclusions: Both intravenous tranexamic acid, sublingual misoprostol could be prescribed as standard therapy to significantly control blood loss and increase the quality of surgery with better outcomes. But the use of TXA proved slightly better as there were lesser side effects and significantly lesser blood loss in uncomplicated cases.

Full text

April 2023 · Volume 12 · Issue 4 Page 1
International Journal of Reproduction, Contraception, Obstetrics and Gynecology
Rao DM et al. Int J Reprod Contracept Obstet Gynecol. 2023 Apr;12(4):xxx-xxx
www.ijrcog.org
pISSN 2320-1770 | eISSN 2320-1789
Original Research Article
Comparison of intravenous tranexamic acid versus sublingual
misoprostol in reducing blood loss in patients undergoing caesarean
section-an analytical observational study
Deeksha Rao M., Munikrishna M.*
INTRODUCTION
Obstetric haemorrhage is the leading cause of maternal
mortality worldwide, irrespective of the mode of delivery.
CS is one of the most commonly performed major
operations in women throughout the world, escalating
between 20 and 30% in most developed countries over the
past four decades.1 India is representative of the magnitude
of this problem. The increasing incidence of CS has
contributed to postpartum haemorrhage (PPH), as the
average blood loss during CS is twice that of vaginal
delivery, which accounts for nearly 25% of maternal
deaths.2,3 Annually about 530000 women die in the world
as a consequence of pregnancy or childbirth, and 14
million women suffer blood loss, with 2% of deaths
occurring in 2-4 hours after blood loss starts.4 Although
there has been a remarkable improvement in the
prevention and treatment of blood loss during CS in recent
years, deaths due to blood loss remain relatively common
in some parts of the world. To lower the occurrence rate of
major morbidity and mortality due to blood loss during CS,
DOI: https://dx.doi.org/10.18203/2320-1770.ijrcog20230677
Department of Obstetrics and Gynaecology, Sri Devaraj URS Medical College, Kolar, Karnataka, India
Received: 02 January 2023
Accepted: 09 March 2023
*Correspondence:
Dr. Munikrishna M.,
E-mail: drmunikrishna_m@rediffmail.com
Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.
ABSTRACT
Background: Preventing postpartum haemorrhage using uterotonics or other antifibrinolytic drugs is need of the hour
among women undergoing caesarean section (CS). This study is to compare the effectiveness of intravenous
Tranexamic acid versus sublingual misoprostol in reducing blood loss by assessing intraoperative and postoperative
blood loss in patients undergoing CS.
Methods: Analytical observational study was conducted in department of obstetrics and gynaecology at sri Devaraj
URS medical college, among 118 pregnant women admitted for CS. Study was conducted between January 2020 to
June 2021. The sample was divided equally into intravenous tranexamic acid and sublingual misoprostol groups.
Number of mops, pads soaked, suction volume excluding the amniotic fluid, preoperative and post-operative
haemoglobin, any complication were recorded.
Results: The mean of mops counts in the misoprostol, TXA group were noted as 4.73±1.27, 3.2±1.45 respectively.
Around 8.47% of the participants in the misoprostol group required uterotonics, whereas, 15.25% in the TXA group
required uterotonics. The preoperative and postoperative haemoglobin in misoprostol group were identified as
11.67±1.37, 10.78±1.12 respectively, whereas it was identified as 11.76±1.43, 11.17±1.4 in TXA group. The common
side effects identified in the misoprostol group was chills, vomiting and fever with 47.46%, 13.56% and 11.86% while,
it was 11.86%, 5.08% and 3.39% in the TXA group.
Conclusions: Both intravenous tranexamic acid, sublingual misoprostol could be prescribed as standard therapy to
significantly control blood loss and increase the quality of surgery with better outcomes. But the use of TXA proved
slightly better as there were lesser side effects and significantly lesser blood loss in uncomplicated cases.
Keywords: Haemorrhage, Uterotonics, CS, Postpartum, Anti-fibrinolytic agents

Rao DM et al. Int J Reprod Contracept Obstet Gynecol. 2023 Apr;12(4):xxx-xxx
International Journal of Reproduction, Contraception, Obstetrics and Gynecology Volume 12 · Issue 4 Page 2
preventive measures should be taken to reduce
intraoperative blood loss during CS.
Anti-fibrinolytic agents, such as tranexamic acid (TA),
reduce the risk of death due to bleeding in trauma patients,
and it has been suggested that TA administration reduces
blood loss in females after vaginal or elective CS.5 A
recent systematic review and mathematical model
estimated that almost 22,000 deaths per year could be
averted worldwide if TXA were used prophylactically.6
Misoprostol is a synthetic prostaglandin E1 analog,
commonly used for the prevention and management of
post-operative blood loss with potent uterotonic properties
and fewer side effects at therapeutic doses and can be used
in low-resource settings.7 Youssef et al found preoperative
administration of sublingual misoprostol (400 μg) during
CS is better than postoperative administration, with
reduced intraoperative and postoperative blood loss and
drop in hemoglobin levels.8
Despite searching the available evidence, it was found that
there is a dearth of literature regarding the efficacy of
intravenous TA and sublingual misoprostol in reducing
bleeding after CS, especially in developing countries like
India. Sahhaf et al found no significant differences
between misoprostol to TXA and suggested more studies
with a greater population.9 Therefore, this study was
designed to evaluate and compare the efficacy of these two
therapeutic options in controlling blood loss following CS.
Aims and objectives
Aim and Objectives were to compare the effectiveness of
intravenous tranexamic acid versus sublingual misoprostol
in reducing blood loss by assessing intraoperative and
postoperative blood loss in patients undergoing CS.
METHODS
Study design
Analytical observational study was used.
Study setting
This study was conducted in the department of obstetrics
and gynaecology at sri Devaraj URS medical, Tamaka,
Kolar.
Source population
Pregnant women visiting the department of obstetrics and
gynaecology at sri Devaraj URS medical, Tamaka, Kolar.
Study population
All the eligible patients admitted for CS in the department
of obstetrics and gynaecology at sri Devaraj URS medical
college were considered as the study population.
Study period
The study conducted between January 2020 to June 2021.
Sample size
The sample size was calculated based on the mean suction
blood loss in both tranexamic acid and misoprostol groups
in a previous study by Pakhniat et al.10 Thus considering a
90% power and an alpha error of 1%, a sample size of 59
was taken in each group.
Group A (59)-Intravenous tranexamic acid will be given.
(A dose of 1 gram slowly over 2 minutes, at least 10
minutes before the start of the procedure). Group B (59)-
Sublingual misoprostol of 400 mcg as soon as the baby
was born. In both groups, 20 units of oxytocin were
administered in 1 L of RL with the rate of 1000 CC/h.
Sampling technique
All eligible subjects recruited into study consecutively by
convenient sampling for feasibility of study.
Ethics statement
The study was approved by the institutional human ethics
committee and institutional review board [Reference:
SDUMC/KLR/IEC/147/2019-20]. Data confidentiality
was maintained. Written informed consent was obtained
from the patients.
Inclusion criteria
Woman aged between completed 18 and 40 years,
gestational age between 37 weeks and 42 weeks, singleton
pregnancy and patients undergoing lower segment CS
under spinal anesthesia were included in the study.
Exclusion criteria
Antepartum hemorrhage, pre-eclampsia and eclampsia,
any underlying disease (heart, liver, kidney, pulmonary),
allergic to tranexamic acid (allergy, thromboembolic
events during pregnancy) and misoprostol. Coagulation
disorders, intrauterine fetal demise, polyhydramnios,
fibroid, DIC, anticoagulant therapy and previous history of
uterine rupture were excluded.
Data collection
All the relevant parameters were documented in a
structured study proforma. All the routine investigations
required for preoperative evaluation were done for the
proposed surgery. In the operating room, the IV line was
secured, and the patient was shifted to the OT room under
aseptic precaution. The patient was painted and draped.
Spinal anesthesia was given, and a CS was done.
Intraoperatively, the vitals were recorded.

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International Journal of Reproduction, Contraception, Obstetrics and Gynecology Volume 12 · Issue 4 Page 3
Parameters observed
Number of mops, pads soaked, suction volume excluding
the amniotic fluid. Preoperative and postoperative
hemoglobin and the presence of any complication in the
preoperative and postoperative periods was noted,
particularly in relation to respiratory or cardiovascular
problems, nausea or vomiting, and headache.
Operational definitions
Primary PPH is defined as a blood loss of more than 1000
ml during the first 24 hours after delivery, and it is the most
common cause of maternal mortality worldwide.11
Study variables
Mops, suction volume, preoperative HB, and
postoperative HB were considered as primary outcome
variables.
Statistical analysis
Descriptive analysis was carried out by mean and standard
deviation for quantitative variables, frequency, and
proportion for categorical variables. Categorical outcomes
were compared between study groups using the Chi-square
test /Fisher's Exact test. For normally distributed
Quantitative parameters, the mean values were compared
between study groups using an independent sample t-test.
The change in the quantitative parameters before and after
the intervention was assessed by paired t-test. P<0.05 was
considered statistically significant. IBM SPSS version 22
was used for statistical analysis.12
RESULTS
A total of 118 subjects were included in the final analysis.
Mean age of women in tranexamic acid group was
24.12±3.3 years and in misoprostol group it was
23.81±3.64 years. Mean age difference between 2 groups
was not statistically significant (p=0.634). The 43
(72.88%) in tranexamic acid group and 42 (71.19%) in
misoprostol group in between 37-40 weeks gestational
age. Difference in terms of gestational age not statistically
significant (p=0.837). The 38 (64.41%) in tranexamic acid
group, and 35 (59.32%) in misoprostol group had
emergency CS and difference of groups in terms of type of
CS was not statistically significant (p=0.57) (Table 1).
The mean of mops count was 3.2±1.45 in tranexamic acid
group, and 4.73±1.27 in misoprostol group. The difference
in mops count between study groups was statistically
significant (p<0.001). In tranexamic acid group, 6
(10.17%) participants suction volume was less than 200
ml, for 26 (44.07%) it was between 200 to 400 ml and 27
(45.76%) had between 400 to 600 ml. In misoprostol
group, 8 (13.56%) had suction volume less than 200 ml,
29 (49.15%) had between 200 to 400 ml and 22 (37.29%)
had between 400 to 600 ml and difference in proportions
between the groups was statistically not significant
(p=0.619). Nine (15.25%) participants in tranexamic acid
group and 5 (8.47%) in misoprostol group needed
uterotonics and difference in proportions between groups
was statistically not significant (p=0.255). Only 1(1.69%)
participant needed additional procedure (bilateral internal
iliac artery ligation) to control intraoperative bleeding and
2 (3.39%) participants needed blood transfusion in
tranexamic acid group (Table 2).
Table 1: Comparison of baseline and maternal
parameters between study groups, (n=118).
Parameters
Study groups (Mean± SD)
P
value
Tranexamic
acid, (n=59)
(%)
Misoprostol,
(n=59)
(%)
Age (Years)
24.12±3.3
23.81±3.64
0.634
Gestational age (weeks)
37-40
43 (72.88)
42 (71.19)
0.837
40+1-42
16 (27.1)
17 (28.81)
Type of CS
Elective
21(35.59)
24 (40.68)
0.57
Emergency
38 (64.41)
35 (59.32)
Table 2: Comparison of baseline and maternal
parameters between study groups, (n=118).
Parameters
Study groups (Mean ± SD)
P value
Tranexamic
acid, (n=59)
(%)
Misoprostol,
(n=59)
(%)
Mops count
3.2±1.45
4.73±1.27
<0.001
Suction volume (ml)
<200
6 (10.17)
8 (13.56)
0.619
200-400
26 (44.07)
29 (49.15)
400-600
27 (45.76)
22 (37.29)
Need for
uterotonics
9 (15.25)
5 (8.47)
0.255
Additional
procedure
required
1 (1.69)
0 (0)
*
Blood
transfusion
2 (3.39)
0 (0)
*
*No statistical test was applied- due to 0 subjects in the cells.
There is reduction in post-op hemoglobin in both groups
when compared to preoperative hemoglobin, however, the
mean difference was high in misoprostol group (Table 3).
Out of 59 participants in tranexamic acid group, 7
(11.86%) participants had chills, 3 (5.08%) participants
had vomiting, 2 (3.39%) participants had fever and 5
(8.47%) participants had headache. Out of 59 participants
in misoprostol group, 28 (47.46%) participants had chills,
8 (13.56%) participants had vomiting, 7 (11.86%)
participants had fever and 4 (6.78%) participants had
headache. The difference between two groups was
statistically significant (p<0.001) (Figure 1).

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International Journal of Reproduction, Contraception, Obstetrics and Gynecology Volume 12 · Issue 4 Page 4
Figure 1: Cluster bar chart of comparison of side effects between study groups, (n=118).
Out of 118 participants in total, 25 patients underwent
elective CS, 24 patients underwent emergency CS in view
of fetal distress, 16 in view of previous CS and 16 in view
of maternal desire (Table 4).
Table 3: Comparison of hemoglobin pre to post in 2
groups individually, (n=118).
HB (g/dl)
Mean ± SD
Mean
difference
P value
Tranexamic acid
Pre-operative
11.76±1.43
0.59
<0.001
Post-operative
11.17±1.4
Misoprostol
Pre-operative
11.67±1.37
0.89
<0.001
Post-operative
10.78±1.12
Table 4: Descriptive analysis of indication in the study
groups, (n=118).
Indication
N
Percentages
(%)
Previous LSCS (Elective)
25
21.19
Fetal distress
24
20.34
CDMR
16
13.56
Previous LSCS
(Emergency)
16
13.56
CPD
8
6.78
Oligohydramnios
7
5.93
Contracted pelvis
6
5.08
Failed induction
5
4.24
Malpresentation
4
3.39
Deep transverse arrest
4
3.39
Malpresentation
3
2.54
DISCUSSION
According to the results, there was a significant reduction
in postoperative haemoglobin in both groups when
compared to the preoperative haemoglobin. However, the
mean difference was high in the Misoprostol group
(p<0.001). There are various studies regarding drugs used
to control blood loss during CS. However, authors could
not come across many published studies that compared the
efficacy of misoprostol and TXA during CS to prevent
post-operative blood loss. Hence, authors had to analyse
results with existing data comparing misoprostol and
oxytocin, and those between TXA and oxytocin infusion.
Pakniat et al found significantly lower total bleeding in
sublingual misoprostol compared to the tranexamic acid
group.10 Hemodynamic variables were stabilized greater in
the misoprostol group than in the tranexamic acid group.
Sahhaf et al found no significant differences between
misoprostol and tranexamic acid group in haemorrhage
during labour, postpartum haemoglobin level, and
discharge haemoglobin level, and stated that Misoprostol
has no specific preferences to TXA.9 The differences in
results may be due to the type and dosage of administered
drugs. Bose et al found statistically insignificant reduction
in blood loss in the TXA group compared with the
misoprostol group, irrespective of the presence or absence
of high-risk factors (470.30 vs 491.74 mL, p=0.487).2
One (1.69%) participant needed an additional procedure to
control intraoperative bleeding, and 2 (3.39%) participants
needed a blood transfusion in the tranexamic acid group in
the present study. Li et al in their systematic review and
meta-analysis found the lesser risk of blood transfusions
with tranexamic acid, which contrast with the present
study finding.13 Chaudhuri et al compared Misoprostol and
oxytocin versus oxytocin and placebo in reduction of

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International Journal of Reproduction, Contraception, Obstetrics and Gynecology Volume 12 · Issue 4 Page 5
blood loss during and after CS.14 The mean postoperative
blood loss was lower in the misoprostol group than in the
placebo group, but the difference was not statistically
significant (p=0.07). In the present study, sublingual
Misoprostol of 400mcg was given as soon as the baby was
born, and 20 units of oxytocin were administered in 1 L of
RL at the rate of 1000 CC/h.
In present study, misoprostol group had higher side effects,
with 28 (47.46%) participants having chills, 8 (13.56%)
having vomiting, and 7 (11.86%) having fever. Similarly,
Othman et al found more frequent temporary side effects,
including shivering and metallic taste, with use of
sublingual misoprostol.15 Tabatabaie et al found no side
effects, as nausea and diarrhoea with tranexamic acid, and
also no complications of misoprostol, as headache, nausea,
uterine cramps, stomach ache, diarrhoea, flatulence, and
fever, or serious complications, such as uterine rupture,
coagulation disorders, as well as severe and abnormal
vaginal bleeding.16 Okonofua et al reported to include
additional uterotonics and other ancillary treatments for
ineffective reduction of blood loss due to PPH.17
Most reported studies used sublingual misoprostol to
manage post-operative blood loss; nevertheless, a few
studies used it as a preventive measure, as the current
study. Our study supports the fact that sublingual
misoprostol is effective in reducing postpartum blood loss
and required less additional oxytocic drugs but without
statistical significance. In comparison to the oral and rectal
route, sublingual administration is more convenient, leads
to rapid absorption, and effects are comparable.15
A CS is the most common major operation performed on
women worldwide. Despite routine use of oxytocin during
caesarean delivery, a number of women, especially those
at high risk, may develop uterine atony and haemorrhage
either during surgery or in the immediate postoperative
period, with serious consequences. Any modality of
treatment, which helps in its prevention, will be useful in
reducing maternal mortality and morbidity. Misoprostol is
an evidence-based alternative to other uterotonic agents
due to its wide availability, low cost, stability at room
temperature, and ease of use. Intra-venous administration
of TXA has been routinely used for many years to reduce
haemorrhage during and after many surgical procedures.
And it’s use has been increasing in recent years as it has
shown to be effective and safe in women undergoing CS.18
The council on patient safety in women's health care out-
lined essential steps that delivery units should take to
decrease the incidence and severity of postpartum
hemorrhage.19 The creation of a haemorrhage cart with
supplies and the use of huddles, rapid response teams, and
massive transfusion protocols are among the
recommendations. Advanced life support in obstetrics
(ALSO) training can be part of a systems approach to
improving patient care. The use of interdisciplinary team
training with, in situ simulations, available through the
ALSO program and from team STEPPS (Team strategies
and tools to enhance performance and patient safety), has
been shown to improve perinatal safety.20
Limitations
The study was conducted in a single center, and findings
cannot be applied to general community. The dose
response or the effects of multiple dose therapy were not
evaluated in present study. Accuracy in estimating blood
loss cannot be ensured. the relationship between the causes
of CS and the level of bleeding was not assessed in the
current study. Further multicentric studies with large
sample are recommended to support the findings of present
study.
CONCLUSION
Both intravenous tranexamic acid and sublingual
misoprostol could be prescribed as standard therapy to
significantly control blood loss and increase the quality of
surgery with better outcomes. But the use of TXA proved
slightly better as there were lesser side effects and
significantly lesser blood loss in uncomplicated cases.
Funding: No funding sources
Conflict of interest: None declared
Ethical approval: The study was approved by the
Institutional Ethics Committee
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Cite this article as: Rao DM, Munikrishna M.
Comparison of intravenous tranexamic acid versus
sublingual misoprostol in reducing blood loss in
patients undergoing caesarean section-an analytical
observational study. Int J Reprod Contracept Obstet
Gynecol 2023;12:xxx-xx.