Trial Outcomes & Findings for Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section (NCT NCT03463993)

NCT ID: NCT03463993

Last Updated: 2022-06-01

Results Overview

PPH based on Haematocrit calculation and PPH based on Haemoglobin calculation

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 506 participants
• Primary outcome timeframe: Up to 48 hours post-caesarean section
• Results posted on: 2022-06-01

Participant Flow

From 8 April 2018 to 31 December 2018, we recruited 506 eligible patients. The trial was conducted at two tertiary institutions that are affiliated to the University of Zimbabwe. These serve as referral centres for 12 local authority clinics located in Harare as well as district and provincial hospitals in the surrounding provinces: Harare Central Hospital i.e. Harare Maternity Hospital (HMH) and Parirenyatwa Group of Hospitals i.e. Mbuya Nehanda Maternity Hospital (MNMH).

Participant milestones

Measure	Group A Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Overall Study STARTED	253	253
Overall Study COMPLETED	224	227
Overall Study NOT COMPLETED	29	26

Reasons for withdrawal

Measure	Group A Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Overall Study Lost to Follow-up	7	8
Overall Study Withdrawal by Subject	2	0
Overall Study Protocol Violation	4	1
Overall Study Had a vaginal delivery prior to caesarean delivery	9	11
Overall Study Had emergency caesarean delivery prior to elective caesarean delivery	7	6

Baseline Characteristics

Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section

Baseline characteristics by cohort

Measure	Group A n=224 Participants Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B n=227 Participants Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Total n=451 Participants Total of all reporting groups
Age, Continuous	29.5 years STANDARD_DEVIATION 6.0 • n=5 Participants	29.7 years STANDARD_DEVIATION 6.5 • n=7 Participants	29.6 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	224 Participants n=5 Participants	227 Participants n=7 Participants	451 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black African	224 Participants n=5 Participants	227 Participants n=7 Participants	451 Participants n=5 Participants
Region of Enrollment Zimbabwe	224 participants n=5 Participants	227 participants n=7 Participants	451 participants n=5 Participants
Gestational age	39 Weeks n=5 Participants	39 Weeks n=7 Participants	39 Weeks n=5 Participants
HIV status Positive	27 Participants n=5 Participants	35 Participants n=7 Participants	62 Participants n=5 Participants
HIV status Negative	186 Participants n=5 Participants	187 Participants n=7 Participants	373 Participants n=5 Participants
HIV status Unknown	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Multiple pregnancy	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Placenta praevia	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Uterine fibroids	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Weight	78.3 kilograms STANDARD_DEVIATION 14.9 • n=5 Participants	78.2 kilograms STANDARD_DEVIATION 15.2 • n=7 Participants	78.3 kilograms STANDARD_DEVIATION 15.0 • n=5 Participants
Body mass index	29.8 kg/m^2 STANDARD_DEVIATION 5.3 • n=5 Participants	30.5 kg/m^2 STANDARD_DEVIATION 5.5 • n=7 Participants	30.1 kg/m^2 STANDARD_DEVIATION 5.4 • n=5 Participants
Number of previous caesarean sections 1	82 Participants n=5 Participants	87 Participants n=7 Participants	169 Participants n=5 Participants
Number of previous caesarean sections 2	38 Participants n=5 Participants	44 Participants n=7 Participants	82 Participants n=5 Participants
Number of previous caesarean sections ≥3	5 Participants n=5 Participants	13 Participants n=7 Participants	18 Participants n=5 Participants
Number of previous caesarean sections 0	99 Participants n=5 Participants	83 Participants n=7 Participants	182 Participants n=5 Participants
Previous surgery	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Anaemia (Hb < 11 g/dl)	44 Participants n=5 Participants	51 Participants n=7 Participants	95 Participants n=5 Participants
Foetal macrosomia (birth weight > 4000g)	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Breech presentation	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Risk assessment for PPH Low	194 Participants n=5 Participants	195 Participants n=7 Participants	389 Participants n=5 Participants
Risk assessment for PPH Medium	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Risk assessment for PPH High	16 Participants n=5 Participants	25 Participants n=7 Participants	41 Participants n=5 Participants
Type of anaesthesia General	33 Participants n=5 Participants	24 Participants n=7 Participants	57 Participants n=5 Participants
Type of anaesthesia Regional (spinal)	176 Participants n=5 Participants	188 Participants n=7 Participants	364 Participants n=5 Participants
Type of anaesthesia Missing	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 48 hours post-caesarean section

Population: Intention-to-treat population

PPH based on Haematocrit calculation and PPH based on Haemoglobin calculation

Outcome measures

Measure	Group A n=224 Participants Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B n=227 Participants Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Number of Participants With Postpartum Haemorrhage (PPH) PPH based on Haematocrit calculation	48 Participants	54 Participants
Number of Participants With Postpartum Haemorrhage (PPH) PPH based on Haemoglobin calculation	56 Participants	71 Participants

SECONDARY outcome

Timeframe: At caesarean section

Population: Intention-to-treat population

Blood loss during caesarean section based on visual estimation and calculation.

Outcome measures

Measure	Group A n=224 Participants Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B n=227 Participants Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Estimated Blood Loss Visually estimated blood loss	483.73 ml Standard Deviation 182.56	479.61 ml Standard Deviation 139.49
Estimated Blood Loss Haematocrit-based calculation of estimated blood loss	650.06 ml Standard Deviation 631.50	653.05 ml Standard Deviation 796.03
Estimated Blood Loss Haemoglobin-based calculation of estimated blood loss	644.30 ml Standard Deviation 692.27	707.68 ml Standard Deviation 948.01

SECONDARY outcome

Timeframe: At caesarean section up to 48 hours post-caesarean section

Population: Intention-to-treat population

Requirement by participant of blood transfusion

Outcome measures

Measure	Group A n=224 Participants Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B n=227 Participants Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Amount of Blood Transfused	1.5 units of blood given Interval 1.0 to 2.0	2.5 units of blood given Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: At caesarean section up to 48 hours post-caesarean section

Population: Intention-to-treat analysis

Number of participants who received additional uterotonics such as an oxytocin infusion or prostaglandin (misoprostol).

Outcome measures

Measure	Group A n=224 Participants Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B n=227 Participants Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Number of Participants With Use of Additional Uterotonics	38 Participants	32 Participants

SECONDARY outcome

Timeframe: From intravenous infusion of the drug up to 48 hours post-caesarean section

Population: Intention-to-treat population

Number of participants with adverse effects related to tranexamic acid use

Outcome measures

Measure	Group A n=224 Participants Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B n=227 Participants Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Number of Participants With Tranexamic Acid Side Effects	7 Participants	3 Participants

SECONDARY outcome

Timeframe: At caesarean section up to 48 hours post-caesarean section

Population: Intention-to-treat analysis

Number of participants requiring emergency surgical procedures to manage any PPH that occurs

Outcome measures

Measure	Group A n=224 Participants Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B n=227 Participants Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Number of Participants Requiring Emergency Surgery for PPH	0 Participants	2 Participants

SECONDARY outcome

Timeframe: From date of randomization until the day 2 post-caesarean section (date of discharge from hospital) or date of death whichever comes earlier

Population: Intention-to-treat population

The number of days the participant stayed in hospital from the date of admission to date of discharge from hospital.

Outcome measures

Measure	Group A n=224 Participants Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B n=227 Participants Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Number of Days of Participants' Hospital Stay	5 days Interval 4.0 to 5.0	5 days Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier

Population: Intention-to-treat population

Neonatal birth weight in grams

Outcome measures

Measure	Group A n=224 Participants Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B n=227 Participants Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Neonatal Outcome - Weight	3087.85 grams Standard Deviation 523.98	3109.98 grams Standard Deviation 513.13

SECONDARY outcome

Timeframe: Scores at 1 minute from time of delivery and at 5 minutes after delivery

Population: Intention-to-treat analysis

APGAR (Appearance, Pulse, Grimace, Activity, Respiration) scores out of 10 at 1 minute and 5 minutes. A measure of the physical condition of a newborn infant. It is obtained by adding points (maximum score of 2, 1, or 0 as minimum score) for Appearance (0 - blue/pale, 1 - pink body, blue extremities, 2 - pink); Pulse (0 - absent heart rate, 1 - below 100 beats per minute, 2 - over 100 beats per minute), Grimace (Reflex irritability - 0 - floppy, 1 - minimal response to stimulation, 2- prompt response to stimulation), Activity (muscle tone: 0 - absent, 1 - Flexed arms and legs, 2 - active), Respiration ( 0 - absent, 1 - slow or irregular, 2 - vigorous cry). APGAR score at 1minute or 5 minute can be a minimum of of 0 (0+0+0+0+0) or maximum of 10 (2 for each parameter above).

Outcome measures

Measure	Group A n=224 Participants Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B n=227 Participants Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Neonatal Outcome - APGAR Score of the Neonates at 1 Minute and 5 Minutes After Delivery Apgar score at 1 minute	8 units on a scale up to 10 Interval 8.0 to 9.0	9 units on a scale up to 10 Interval 8.0 to 9.0
Neonatal Outcome - APGAR Score of the Neonates at 1 Minute and 5 Minutes After Delivery Apgar score at 5 minutes	9 units on a scale up to 10 Interval 9.0 to 10.0	9 units on a scale up to 10 Interval 9.0 to 10.0

SECONDARY outcome

Timeframe: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier

Population: Intention-to-treat population

Number of neonates requiring admission to the neonatal unit from time of delivery at caesarean section

Outcome measures

Measure	Group A n=224 Participants Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B n=227 Participants Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Neonatal Outcome - Number of Neonates Admitted to the Neonatal Unit	33 Participants	23 Participants

SECONDARY outcome

Timeframe: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier

Population: Intention-to-treat population

Number of neonates with clinical jaundice (yellowing of the skin or whites of the eyes)

Outcome measures

Measure	Group A n=224 Participants Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B n=227 Participants Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Neonatal Outcome - Number of Neonates Diagnosed With Jaundice	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier

Population: Intention-to-treat population

Number of neonatal thromboembolic events

Outcome measures

Measure	Group A n=224 Participants Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B n=227 Participants Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Neonatal Outcome - Thromboembolic Event	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier

Population: Intention-to-treat population

Neonatal death that occurs

Outcome measures

Measure	Group A n=224 Participants Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B n=227 Participants Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Neonatal Outcome - Death	1 Participants	1 Participants

Adverse Events

Group A

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group A n=224 participants at risk Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby. Tranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision. Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.	Group B n=227 participants at risk Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby Oxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
Cardiac disorders Hypotension	1.3% 3/224 • Adverse event data was collected up to the time the patient and baby were discharged from hospital which on average is on the third day post-caesarean section. The risk of serious adverse events is zero as these are rare events with tranexamic acid administration. The all-cause mortality is zero again as this is a rare event. The common adverse effects include headaches (50.4 - 60.4%), backaches (20.7 - 31.4%), nasal sinus congestion (25.4%), abdominal pain (12 - 19.8%), diarrhoea (12.2%), fatigue (5.2%) and anaemia (5.6%). The WOMAN Trial collaborators found that TXA reduces mortality due to bleeding in women with PPH with no adverse effects.	0.44% 1/227 • Adverse event data was collected up to the time the patient and baby were discharged from hospital which on average is on the third day post-caesarean section. The risk of serious adverse events is zero as these are rare events with tranexamic acid administration. The all-cause mortality is zero again as this is a rare event. The common adverse effects include headaches (50.4 - 60.4%), backaches (20.7 - 31.4%), nasal sinus congestion (25.4%), abdominal pain (12 - 19.8%), diarrhoea (12.2%), fatigue (5.2%) and anaemia (5.6%). The WOMAN Trial collaborators found that TXA reduces mortality due to bleeding in women with PPH with no adverse effects.
Nervous system disorders Headache	0.45% 1/224 • Adverse event data was collected up to the time the patient and baby were discharged from hospital which on average is on the third day post-caesarean section. The risk of serious adverse events is zero as these are rare events with tranexamic acid administration. The all-cause mortality is zero again as this is a rare event. The common adverse effects include headaches (50.4 - 60.4%), backaches (20.7 - 31.4%), nasal sinus congestion (25.4%), abdominal pain (12 - 19.8%), diarrhoea (12.2%), fatigue (5.2%) and anaemia (5.6%). The WOMAN Trial collaborators found that TXA reduces mortality due to bleeding in women with PPH with no adverse effects.	0.44% 1/227 • Adverse event data was collected up to the time the patient and baby were discharged from hospital which on average is on the third day post-caesarean section. The risk of serious adverse events is zero as these are rare events with tranexamic acid administration. The all-cause mortality is zero again as this is a rare event. The common adverse effects include headaches (50.4 - 60.4%), backaches (20.7 - 31.4%), nasal sinus congestion (25.4%), abdominal pain (12 - 19.8%), diarrhoea (12.2%), fatigue (5.2%) and anaemia (5.6%). The WOMAN Trial collaborators found that TXA reduces mortality due to bleeding in women with PPH with no adverse effects.
Gastrointestinal disorders Nausea	0.89% 2/224 • Adverse event data was collected up to the time the patient and baby were discharged from hospital which on average is on the third day post-caesarean section. The risk of serious adverse events is zero as these are rare events with tranexamic acid administration. The all-cause mortality is zero again as this is a rare event. The common adverse effects include headaches (50.4 - 60.4%), backaches (20.7 - 31.4%), nasal sinus congestion (25.4%), abdominal pain (12 - 19.8%), diarrhoea (12.2%), fatigue (5.2%) and anaemia (5.6%). The WOMAN Trial collaborators found that TXA reduces mortality due to bleeding in women with PPH with no adverse effects.	0.00% 0/227 • Adverse event data was collected up to the time the patient and baby were discharged from hospital which on average is on the third day post-caesarean section. The risk of serious adverse events is zero as these are rare events with tranexamic acid administration. The all-cause mortality is zero again as this is a rare event. The common adverse effects include headaches (50.4 - 60.4%), backaches (20.7 - 31.4%), nasal sinus congestion (25.4%), abdominal pain (12 - 19.8%), diarrhoea (12.2%), fatigue (5.2%) and anaemia (5.6%). The WOMAN Trial collaborators found that TXA reduces mortality due to bleeding in women with PPH with no adverse effects.
Gastrointestinal disorders Vomiting	0.45% 1/224 • Adverse event data was collected up to the time the patient and baby were discharged from hospital which on average is on the third day post-caesarean section. The risk of serious adverse events is zero as these are rare events with tranexamic acid administration. The all-cause mortality is zero again as this is a rare event. The common adverse effects include headaches (50.4 - 60.4%), backaches (20.7 - 31.4%), nasal sinus congestion (25.4%), abdominal pain (12 - 19.8%), diarrhoea (12.2%), fatigue (5.2%) and anaemia (5.6%). The WOMAN Trial collaborators found that TXA reduces mortality due to bleeding in women with PPH with no adverse effects.	0.44% 1/227 • Adverse event data was collected up to the time the patient and baby were discharged from hospital which on average is on the third day post-caesarean section. The risk of serious adverse events is zero as these are rare events with tranexamic acid administration. The all-cause mortality is zero again as this is a rare event. The common adverse effects include headaches (50.4 - 60.4%), backaches (20.7 - 31.4%), nasal sinus congestion (25.4%), abdominal pain (12 - 19.8%), diarrhoea (12.2%), fatigue (5.2%) and anaemia (5.6%). The WOMAN Trial collaborators found that TXA reduces mortality due to bleeding in women with PPH with no adverse effects.

Additional Information

Dr Chipo Gwanzura

University of Zimbabwe

Phone: +263774718381

Email: chipo.gwanzura@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place