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

Postpartum Hemorrhage Clinical Trial

— ETAPPH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04733157
• Other study ID #: ETAPPH
• Secondary ID: D43TW009343
• Status: Completed
• Phase: Phase 3
• Start date: March 23, 2021
• Est. completion date: December 14, 2021

Study information

• Verified date: February 2023
• Source: University of Zimbabwe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1226
• Est. completion date: December 14, 2021
• Est. primary completion date: December 14, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Tranexamic acid injection
Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section

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

Locations

Country	Name	City	State
Zimbabwe	Parirenyatwa Group of Hospitals (Mbuya Nehanda Maternity Hospital)	Harare
Zimbabwe	Sally Mugabe Central Hospital Maternity Unit	Harare

Sponsors (2)

Lead Sponsor	Collaborator
University of Zimbabwe	Fogarty International Center of the National Institute of Health

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Postpartum Hemorrhage (PPH)	Calculated estimated blood loss exceeding 1000ml. Estimated Blood Loss (EBL) was calculated using laboratory values of hemoglobin levels before and after procedure. Postpartum hemorrhage is defined as blood loss exceeding 1000mL after cesarean section.	Up to day 2 postpartum
Secondary	Blood Loss Using Hemoglobin Values	Calculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values	Up to day 2 postpartum
Secondary	Mean Blood Loss as Estimated by Obstetrician	Visually estimated blood loss at time of caesarean section. Attending obstetrician gave an estimated value of blood loss after delivery.	2 hours
Secondary	Occurrence of Postpartum Shock	Number of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse.	Up to day 2 postpartum
Secondary	Use of Supplementary Uterotonic(s)	Number of women requiring supplementary uterotonics	Up to day 2 postpartum
Secondary	Postpartum Transfusion	Number of women given postpartum transfusion	Up to day 2 postpartum
Secondary	Emergency Surgery for PPH	Number of participants who had emergency surgery for PPH including caesarean hysterectomies	Up to day 2 postpartum
Secondary	Change in Peripartum Haemoglobin	Mean change in haemoglobin concentration between the study group, calculated hemoglobin values at day 2 postpartum minus baseline hemoglobin values.	Up to day 2 postpartum
Secondary	Number of Participants With a Decrease in Peripartum Hemoglobin	Number of participants with a drop in hemoglobin more than 2g/dL or less than 2g/dL	Up to day 2 postpartum
Secondary	Change in Peripartum Haematocrit	Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum	Up to day 2 postpartum
Secondary	Admission Into Intensive Care Unit	Number of participants transferred to intensive care unit	Up to day 2 postpartum
Secondary	Death From Any Cause	Number of participants who died from any cause	Up to date of death or day 4 from admission
Secondary	Blood Pressure Measurements	Blood pressure at 15, 30, 45, 60, and 120 min after delivery	Up to 2 hours after the caesarean section
Secondary	Number of Mild Adverse Events	Number of mild events of nausea, vomiting, sensation of rings or spots of light in the visual field, dizziness	Up to 24 hours after administration
Secondary	Number of Severe Adverse Events	Deep vein thrombosis (if the diagnosis is confirmed by Doppler ultrasound); Pulmonary embolism (if the diagnosis is confirmed by radiological examination); Myocardial infarction; Seizure; Renal failure requiring dialysis	Up to day 3 postpartum
Secondary	Any Other Unexpected Adverse Event	Number of unexpected events during and after the adminstration of study drug and duration of observation	Up to day 3 postpartum
Secondary	Length of Hospital Stay	Duration of hospital admission in days	Up to day 3 postpartum