Phase 3
Completed N=1,226
The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
Source: ClinicalTrials.gov NCT04733157 ↗Enrolled (actual)
1,226
Serious AEs
0.1%
Results posted
Mar 2023
Primary outcomePrimary: Number of Participants With Postpartum Hemorrhage (PPH) — 409; 399; 111; 125 Participants — p=0.33
◆ Published Evidence
Emerging
18citations · ~6 / year
Effect of anesthesia administration method on apgar scores of infants born to women undergoing elective cesarean section.
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.
Linked Publications
-
Effect of anesthesia administration method on apgar scores of infants born to women undergoing elective cesarean section.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.