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

NCT04733157 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: ETAPPHD43TW009343
• Study Type: interventional
• Target: 1,226
• Locations: 1 country
• Sites: 2

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.

Conditions

Postpartum Hemorrhage

Keywords

Postpartum hemorrhage; Tranexamic acid; Caesarean section; Prevent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Blood Loss Using Hemoglobin Values

  Up to day 2 postpartum

• Mean Blood Loss as Estimated by Obstetrician

  2 hours

• Occurrence of Postpartum Shock

  Up to day 2 postpartum

• Use of Supplementary Uterotonic(s)

  Up to day 2 postpartum

• Postpartum Transfusion

  Up to day 2 postpartum

Study Arms (2)

Study group/Group A

EXPERIMENTAL

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

Drug: Tranexamic acid injection

Control group/Group B

PLACEBO COMPARATOR

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

Other: Normal saline placebo

Interventions

Tranexamic acid injection DRUG

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

Also known as: TXA

Study group/Group A

Normal saline placebo OTHER

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

Control group/Group B

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zimbabwe: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (2)

Parirenyatwa Group of Hospitals (Mbuya Nehanda Maternity Hospital)

Harare, Zimbabwe

Location

Sally Mugabe Central Hospital Maternity Unit

Harare, Zimbabwe

Location

Related Publications (1)

• 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.

  PMID: 37106343 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Chipo Gwanzura
• Organization: University of Zimbabwe

chipo.gwanzura@gmail.com

+263774718381

Study Officials

• Chipo Gwanzura, MD

  University of Zimbabwe

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: February 1, 2021
• Study Start: March 23, 2021
• Primary Completion: December 14, 2021
• Study Completion: December 14, 2021
• Last Updated: March 20, 2023
• Results First Posted: March 20, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ZI (2)