Phase 3
N=1,226
The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
Postpartum Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT04733157 ↗Enrolled (actual)
1,226
Serious AEs
0.1%
Results posted
Mar 2023
Primary outcome: Primary: Number of Participants With Postpartum Hemorrhage (PPH) — 409; 399; 111; 125 Participants — p=0.33
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tranexamic acid injection (Drug); Normal saline placebo (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- University of Zimbabwe
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Postpartum Hemorrhage (PPH) |
409; 399; 111; 125 | 0.33 |
| SECONDARY Blood Loss Using Hemoglobin Values |
537.2; 528.6 | — |
| SECONDARY Mean Blood Loss as Estimated by Obstetrician |
501.2; 495.0 | — |
| SECONDARY Occurrence of Postpartum Shock |
603; 611; 8; 2 | — |
| SECONDARY Use of Supplementary Uterotonic(s) |
93; 74; 252; 232 | — |
| SECONDARY Postpartum Transfusion |
8; 9; 603; 604 | — |
| SECONDARY Emergency Surgery for PPH |
603; 601; 4; 4 | — |
| SECONDARY Change in Peripartum Haemoglobin |
1.1; 1.16 | — |
| SECONDARY Number of Participants With a Decrease in Peripartum Hemoglobin |
438; 442; 117; 125 | — |
| SECONDARY Change in Peripartum Haematocrit |
3.8; 3.6 | — |
| SECONDARY Admission Into Intensive Care Unit |
75; 75; 525; 531 | — |
| SECONDARY Death From Any Cause |
611; 613; 0; 0 | — |
| SECONDARY Blood Pressure Measurements |
132.2; 131.2; 64.9; 69.1; 118.3; 119.0 | — |
| SECONDARY Number of Mild Adverse Events |
9; 16; 602; 597; 29; 18 | — |
| SECONDARY Number of Severe Adverse Events |
0; 0; 611; 613; 0; 0 | — |
| SECONDARY Any Other Unexpected Adverse Event |
0; 0; 611; 613 | — |
| SECONDARY Length of Hospital Stay |
3.5; 3.5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04733157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.