Clinical trial NCT04733157: The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
Official title: The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postpartum Hemorrhage
Keywords: Postpartum hemorrhage
Tranexamic acid
Caesarean section
Prevent
Lead sponsor: University of Zimbabwe
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2021-02-01
Enrollment: 1226
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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. .

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Postpartum Hemorrhage (PPH)
timeFrame: Up to day 2 postpartum
Secondary outcomes:
measure: Blood Loss Using Hemoglobin Values
timeFrame: Up to day 2 postpartum
measure: Mean Blood Loss as Estimated by Obstetrician
timeFrame: 2 hours
measure: Occurrence of Postpartum Shock
timeFrame: Up to day 2 postpartum
measure: Use of Supplementary Uterotonic(s)
timeFrame: Up to day 2 postpartum
measure: Postpartum Transfusion
timeFrame: Up to day 2 postpartum
measure: Emergency Surgery for PPH
timeFrame: Up to day 2 postpartum
measure: Change in Peripartum Haemoglobin
timeFrame: Up to day 2 postpartum
measure: Number of Participants With a Decrease in Peripartum Hemoglobin
timeFrame: Up to day 2 postpartum
measure: Change in Peripartum Haematocrit
timeFrame: Up to day 2 postpartum
measure: Admission Into Intensive Care Unit
timeFrame: Up to day 2 postpartum
measure: Death From Any Cause
timeFrame: Up to date of death or day 4 from admission
measure: Blood Pressure Measurements
timeFrame: Up to 2 hours after the caesarean section
measure: Number of Mild Adverse Events
timeFrame: Up to 24 hours after administration
measure: Number of Severe Adverse Events
timeFrame: Up to day 3 postpartum
measure: Any Other Unexpected Adverse Event
timeFrame: Up to day 3 postpartum
measure: Length of Hospital Stay
timeFrame: Up to day 3 postpartum
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: Parirenyatwa Group of Hospitals (Mbuya Nehanda Maternity Hospital)
city: Harare
country: Zimbabwe
facility: Sally Mugabe Central Hospital Maternity Unit
Study officials:
affiliation: University of Zimbabwe
name: Chipo Gwanzura, MD
role: PRINCIPAL_INVESTIGATOR
References: