NCT04733157 (ETAPPH) is a Phase 3 clinical trial of Tranexamic acid injection in Postpartum Hemorrhage, sponsored by University of Zimbabwe.

Who is sponsoring NCT04733157?

NCT04733157 is sponsored by University of Zimbabwe.

What drugs are being tested in NCT04733157?

Interventions in NCT04733157: Tranexamic acid injection, Normal saline placebo.

What condition does NCT04733157 study?

NCT04733157 studies Postpartum Hemorrhage.

Is NCT04733157 still recruiting?

NCT04733157 is currently completed. Last updated 20 March 2023.

Are results published for NCT04733157?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-03-20 · How we verify

NCT04733157: ETAPPH

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 20 March 2023

What this trial tests

Phase 3 trial testing Tranexamic acid injection in Postpartum Hemorrhage in 1,226 participants. Completed in 14 December 2021.

Timeline

23 March 2021

Primary endpoint
14 December 2021

14 December 2021

Quick facts

Lead sponsor	University of Zimbabwe
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	1,226
Start date	23 March 2021
Primary completion	14 December 2021
Estimated completion	14 December 2021
Sites	2 locations across Zimbabwe

Drugs / interventions tested

Tranexamic acid injection — full drug profile →
Normal saline placebo

Conditions studied

Postpartum Hemorrhage — all drugs for Postpartum Hemorrhage →

Sponsor

University of Zimbabwe

Who can join

Eligibility, female only, with Postpartum Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Postpartum Hemorrhage (PPH) Primary · Up to day 2 postpartum

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.

Group	Value	95% CI
Study Group/Group A_(Tranexamic Acid)	409
Control Group/Group B_(Placebo)	399
Study Group/Group A_(Tranexamic Acid)	111
Control Group/Group B_(Placebo)	125

Blood Loss Using Hemoglobin Values Secondary · Up to day 2 postpartum

Calculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values

Group	Value	95% CI
Study Group/Group A_(Tranexamic Acid)	537.2	± 758.2
Control Group/Group B_(Placebo)	528.6	± 1020.9

Mean Blood Loss as Estimated by Obstetrician Secondary · 2 hours

Visually estimated blood loss at time of caesarean section. Attending obstetrician gave an estimated value of blood loss after delivery.

Group	Value	95% CI
Study Group/Group A_(Tranexamic Acid)	501.2	± 209.8
Control Group/Group B_(Placebo)	495.0	± 188.8

Occurrence of Postpartum Shock Secondary · Up to day 2 postpartum

Number of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse.

No postpartum shock

Group	Value	95% CI
Study Group/Group A_(Tranexamic Acid)	603
Control Group/Group B_(Placebo)	611

Postpartum shock

Group	Value	95% CI
Study Group/Group A_(Tranexamic Acid)	8
Control Group/Group B_(Placebo)	2

Use of Supplementary Uterotonic(s) Secondary · Up to day 2 postpartum

Number of women requiring supplementary uterotonics

No supplementary uterotonic

Group	Value	95% CI
Study Group/Group A_(Tranexamic Acid)	93
Control Group/Group B_(Placebo)	74

Supplementary uterotonic given

Group	Value	95% CI
Study Group/Group A_(Tranexamic Acid)	252
Control Group/Group B_(Placebo)	232

Postpartum Transfusion Secondary · Up to day 2 postpartum

Number of women given postpartum transfusion

Group	Value	95% CI
Study Group/Group A_(Tranexamic Acid)	8
Control Group/Group B_(Placebo)	9
Study Group/Group A_(Tranexamic Acid)	603
Control Group/Group B_(Placebo)	604

Emergency Surgery for PPH Secondary · Up to day 2 postpartum

Number of participants who had emergency surgery for PPH including caesarean hysterectomies

No emergency surgery

Group	Value	95% CI
Study Group/Group A_(Tranexamic Acid)	603
Control Group/Group B_(Placebo)	601

Emergency Surgery done

Group	Value	95% CI
Study Group/Group A_(Tranexamic Acid)	4
Control Group/Group B_(Placebo)	4

Change in Peripartum Haemoglobin Secondary · Up to day 2 postpartum

Mean change in haemoglobin concentration between the study group, calculated hemoglobin values at day 2 postpartum minus baseline hemoglobin values.

Group	Value	95% CI
Study Group/Group A_(Tranexamic Acid)	1.1	± 1.4
Control Group/Group B_(Placebo)	1.16	± 1.7

Number of Participants With a Decrease in Peripartum Hemoglobin Secondary · Up to day 2 postpartum

Number of participants with a drop in hemoglobin more than 2g/dL or less than 2g/dL

drop less than 2g/dl

Group	Value	95% CI
Study Group/Group A_(Tranexamic Acid)	438
Control Group/Group B_(Placebo)	442

drop greater than or equal to 2g/dl

Group	Value	95% CI
Study Group/Group A_(Tranexamic Acid)	117
Control Group/Group B_(Placebo)	125

Change in Peripartum Haematocrit Secondary · Up to day 2 postpartum

Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum

Group	Value	95% CI
Study Group/Group A_(Tranexamic Acid)	3.8	± 4.6
Control Group/Group B_(Placebo)	3.6	± 4.6

Admission Into Intensive Care Unit Secondary · Up to day 2 postpartum

Number of participants transferred to intensive care unit

Group	Value	95% CI
Study Group/Group A_(Tranexamic Acid)	75
Control Group/Group B_(Placebo)	75
Study Group/Group A_(Tranexamic Acid)	525
Control Group/Group B_(Placebo)	531

Death From Any Cause Secondary · Up to date of death or day 4 from admission

Number of participants who died from any cause

Group	Value	95% CI
Study Group/Group A_(Tranexamic Acid)	611
Control Group/Group B_(Placebo)	613
Study Group/Group A_(Tranexamic Acid)	0
Control Group/Group B_(Placebo)	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 week. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Study Group/Group A_(Tranexamic Acid)

Serious: 0/611 (0%)

Deaths: 0/611

Control Group/Group B_(Placebo)

Serious: 1/613 (0%)

Deaths: 0/613

Serious adverse events (1 terms)

Reaction	System	Study Group/Group A_(Trane…	Control Group/Group B_(Pla…
Myocardial Infarction	Cardiac disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Study Group/Group A_(Trane…	Control Group/Group B_(Pla…
Vomiting	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Dizziness	General disorders	—	—

Most-reported serious reactions: Myocardial Infarction.

Data from ClinicalTrials.gov NCT04733157 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Transfusion strategies in bleeding critically ill adults: a clinical practice guideline from the European Society of Intensive Care Medicine.
Vlaar APJ, Dionne JC, de Bruin S, Wijnberge M, et al · · 2021 · cited 65× · PMID 34677620 · DOI 10.1007/s00134-021-06531-x
Effect of anesthesia administration method on apgar scores of infants born to women undergoing elective cesarean section.
Gwanzura C, Gavi S, Mangiza M, Moyo FV, et al · · 2023 · cited 7× · PMID 37106343 · DOI 10.1186/s12871-023-02098-w

Verify or expand the search:

Other trials of Tranexamic acid injection

Trials testing the same drug.

NCT04387305 — Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: An Efficacy Study · Phase 3 · not yet recruiting
NCT06604325 — Prophylactic Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery. · NA · recruiting
NCT06010368 — Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section · Phase 3 · not yet recruiting
NCT06509256 — Different Methods of Tranexamic Acid Application in Controlling Peri Operative Bleeding in Gynecomastia Surgery · EARLY_PHASE1 · not yet recruiting
NCT06522984 — Fractional Erbium YAG Laser vs Intradermal and Systemic Tranexamic Acid · NA · recruiting

Other University of Zimbabwe trials

Trials by the same sponsor.

NCT07195006 — Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories · recruiting
NCT04782739 — Impact of COVID-19 on Provision and Uptake of Prevention of Mother-to-child Transmission of HIV Services in Zimbabwe · completed
NCT04178408 — IBD Registry in a Sub-Saharan African Population · recruiting
NCT03463993 — Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section · Phase 3 · completed
NCT03274960 — Screening and Treating Asymptomatic Bacteriuria Every Trimester and Preterm Birth · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04733157 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Zimbabwe
Last refreshed: 20 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04733157.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing