ETAPPH: The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section

Sponsor

University of Zimbabwe (Other)

Overall Status

Completed

CT.gov ID

NCT04733157

Collaborator

Fogarty International Center of the National Institute of Health (NIH)

1,226

Enrollment

Locations

Arms

8.7

Actual Duration (Months)

613

Patients Per Site

70.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study seeks to determine if the using tranexamic acid prophylactically at caesarean section will prevent postpartum haemorrhage which is a major cause of maternal mortality in Zimbabwe and globally.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Hemorrhage	Drug: Tranexamic acid injection Other: Normal saline placebo	Phase 3

Detailed Description

This trial will be an placebo-controlled, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive tranexamic acid (TXA) 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby. .

Study Design

Study Type:

Interventional

Actual Enrollment :

1226 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This trial will be an open-label, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive TXA 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby.This trial will be an open-label, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive TXA 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby.

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 23, 2021

Actual Primary Completion Date :

Dec 14, 2021

Actual Study Completion Date :

Dec 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group/Group A The study group will receive TXA 1g intravenously at the onset of skin incision.	Drug: Tranexamic acid injection Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section Other Names: TXA
Placebo Comparator: Control group/Group B There is an equivalent volume of normal saline for the control group.	Other: Normal saline placebo 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group

Arm

Intervention/Treatment

Experimental: Study group/Group A

The study group will receive TXA 1g intravenously at the onset of skin incision.

Drug: Tranexamic acid injection

Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section

Other Names:

TXA

Placebo Comparator: Control group/Group B

There is an equivalent volume of normal saline for the control group.

Other: Normal saline placebo

10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group

Outcome Measures

Primary Outcome Measures

Incidence of postpartum hemorrhage (PPH) [Up to day 2 postpartum]
Calculated estimated blood loss exceeding 1000ml or red blood cell transfusion

Secondary Outcome Measures

Blood loss [Up to day 2 postpartum]
Calculated blood loss
Blood loss [2 hours]
Visually estimated blood loss at time of caesarean section
Units of packed red blood cells transfused [Up to day 2 postpartum]
Mean / median number of units of packed red blood cells transfused
Incidence of postpartum shock [Up to day 2 postpartum]
Incidence of hypovolemic shock related to PPH as determined by assessing BP and pulse
Supplementary uterotonic use [Up to day 2 postpartum]
Proportion of women requiring supplementary uterotonics
Postpartum transfusion [Up to day 2 postpartum]
Incidence of postpartum transfusion
Emergency surgery for PPH [Up to day 2 postpartum]
Incidence of emergency surgery for PPH including caesarean hysterectomies
Change in peripartum haemoglobin [Up to day 2 postpartum]
Mean change in haemoglobin
Decrease in peripartum haemoglobin [Up to day 2 postpartum]
Drop in haemoglobin more than 2g/dl
Change in peripartum haematocrit [Up to day 2 postpartum]
Mean change in haematocrit
Admission in Intensive care unit [Up to day 2 postpartum]
Transfer of patient to intensive care unit
Death [Up to date of death or day 4 from admission]
Death from any cause
Blood pressure measurements [Up to 2 hours after the caesarean section]
Blood pressure at 15, 30, 45, 60, and 120 min after delivery
Pulse rate measurements [Up to 2 hours after the caesarean section]
Pulse rate at 15, 30, 45, 60, and 120 min after delivery
Occurrence of mild adverse events [Up to 24 hours after administration]
Occurrence of nausea, vomiting, sensation of rings or spots of light in the visual field, dizziness
Occurrence of severe adverse events [Up to day 3 postpartum]
Deep vein thrombosis (if the diagnosis is confirmed by Doppler ultrasound); pulmonary embolism (if the diagnosis is confirmed by radiological examination); myocardial infarction; seizure v. renal failure requiring dialysis
Any other unexpected adverse event [Up to day 3 postpartum]
Occurrence of an unexpected event
Length of hospital stay [Up to day 3 postpartum]
Duration of hospital admission

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria: Women undergoing elective or emergency caesarean section with:

Estimated gestational age of 37 weeks or more
Live intrauterine foetus
Elective or emergency caesarean delivery
Signed informed consent

Exclusion Criteria:

History of coagulopathies or conditions predisposing them to thromboembolic phenomena,
seizure history,
autoimmune disease,
placental abruption,
placenta praevia,
abnormally adherent placentae if identified on prenatal ultrasound,
eclampsia or HELLP syndrome,
known hypersensitivity to TXA,
planned general anaesthesia,
caesarean delivery for the second twin or second/third triplet(s) after vaginal birth of the first twin,
poor understanding of English/Shona languages,
those who have received anticoagulants in the week before delivery
persons-under-investigation for Coronavirus disease (COVID-19) and confirmed COVID-19 positive women