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

NCT ID: NCT04733157

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-23
• Study Completion Date: 2021-12-14

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. .

Conditions

Postpartum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Study group/Group A

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

Group Type: EXPERIMENTAL

Tranexamic acid injection

Intervention Type: DRUG

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

Control group/Group B

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

Group Type: PLACEBO_COMPARATOR

Normal saline placebo

Intervention Type: OTHER

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

Interventions

Tranexamic acid injection

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

Intervention Type: DRUG

Normal saline placebo

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

Intervention Type: OTHER

Other Intervention Names

TXA

Eligibility Criteria

Inclusion Criteria

• 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

University of Zimbabwe

OTHER

Sponsor Role: lead

Responsible Party

Chipo Gwanzura, MD

Senior Registrar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chipo Gwanzura, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zimbabwe

Locations

Parirenyatwa Group of Hospitals (Mbuya Nehanda Maternity Hospital)

Harare, , Zimbabwe

Sally Mugabe Central Hospital Maternity Unit

Harare, , Zimbabwe

Countries

Zimbabwe

References

Gwanzura C, Gavi S, Mangiza M, Moyo FV, Lohman MC, Nhemachena T, Chipato T. Effect of anesthesia administration method on apgar scores of infants born to women undergoing elective cesarean section. BMC Anesthesiol. 2023 Apr 27;23(1):142. doi: 10.1186/s12871-023-02098-w.

Reference Type: DERIVED

PMID: 37106343 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

D43TW009343

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ETAPPH

Identifier Type: -

Identifier Source: org_study_id