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

University of Zimbabwe

Status and phase: Completed; Phase 3

Conditions: Postpartum Hemorrhage

Treatments: Other: Normal saline placebo; Drug: Tranexamic acid injection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04733157

D43TW009343 (U.S. NIH Grant/Contract)

ETAPPH

Details and patient eligibility

About

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.

Full 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. .

Enrollment: 1,226 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,226 participants in 2 patient groups, including a placebo group

Study group/Group A

Experimental group

Description:

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

Treatment:

Drug: Tranexamic acid injection

Control group/Group B

Placebo Comparator group

Description:

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

Treatment:

Other: Normal saline placebo