Trial · NCT03463993
Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section
NCT03463993, Phase 3, Completed, University of Zimbabwe; results first posted 2022-04-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section. Trials, record NCT03463993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03463993
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section
- NCT number
- NCT03463993
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 506 participants, actual
- Lead sponsor
- University of Zimbabwe
- Conditions
- Post Partum Hemorrhage
- Interventions
- Tranexamic Acid, Oxytocin
- First posted
- 2018-03-13
- Last updated
- 2022-06-01
- Results first posted
- 2022-04-20
- Limitations and caveats
- The a priori power was not been achieved as the target sample size had not yet been achieved due to reasons beyond the scope of the study. The study had no placebo and was not blinded.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Postpartum Haemorrhage (PPH) | Up to 48 hours post-caesarean section | PPH based on Haematocrit calculation and PPH based on Haemoglobin calculation |
| Secondary | Estimated Blood Loss | At caesarean section | Blood loss during caesarean section based on visual estimation and calculation. |
| Secondary | Amount of Blood Transfused | At caesarean section up to 48 hours post-caesarean section | Requirement by participant of blood transfusion |
| Secondary | Number of Participants With Use of Additional Uterotonics | At caesarean section up to 48 hours post-caesarean section | Number of participants who received additional uterotonics such as an oxytocin infusion or prostaglandin (misoprostol). |
| Secondary | Number of Participants With Tranexamic Acid Side Effects | From intravenous infusion of the drug up to 48 hours post-caesarean section | Number of participants with adverse effects related to tranexamic acid use |
| Secondary | Number of Participants Requiring Emergency Surgery for PPH | At caesarean section up to 48 hours post-caesarean section | Number of participants requiring emergency surgical procedures to manage any PPH that occurs |
| Secondary | Number of Days of Participants' Hospital Stay | From date of randomization until the day 2 post-caesarean section (date of discharge from hospital) or date of death whichever comes earlier | The number of days the participant stayed in hospital from the date of admission to date of discharge from hospital. |
| Secondary | Neonatal Outcome - Weight | From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier | Neonatal birth weight in grams |
| Secondary | Neonatal Outcome - APGAR Score of the Neonates at 1 Minute and 5 Minutes After Delivery | Scores at 1 minute from time of delivery and at 5 minutes after delivery | APGAR (Appearance, Pulse, Grimace, Activity, Respiration) scores out of 10 at 1 minute and 5 minutes. A measure of the physical condition of a newborn infant. It is obtained by adding points (maximum score of 2, 1, or 0 as minimum score) for Appearance (0 - blue/pale, 1 - pink body, blue extremities, 2 - pink); Pulse (0 - absent heart rate, 1 - below 100 beats per minute, 2 - over 100 beats per minute), Grimace (Reflex irritability - 0 - floppy, 1 - minimal response to stimulation, 2- prompt response to stimulation), Activity (muscle tone: 0 - absent, 1 - Flexed arms and legs, 2 - active), Respiration ( 0 - absent, 1 - slow or irregular, 2 - vigorous cry). APGAR score at 1minute or 5 minute can be a minimum of of 0 (0+0+0+0+0) or maximum of 10 (2 for each parameter above). |
| Secondary | Neonatal Outcome - Number of Neonates Admitted to the Neonatal Unit | From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier | Number of neonates requiring admission to the neonatal unit from time of delivery at caesarean section |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Postpartum Haemorrhage (PPH) | Up to 48 hours post-caesarean section | Intention-to-treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Estimated Blood Loss | At caesarean section | Intention-to-treat population | ml | MEAN |
| SECONDARY | Amount of Blood Transfused | At caesarean section up to 48 hours post-caesarean section | Intention-to-treat population | units of blood given | MEDIAN |
| SECONDARY | Number of Participants With Use of Additional Uterotonics | At caesarean section up to 48 hours post-caesarean section | Intention-to-treat analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Tranexamic Acid Side Effects | From intravenous infusion of the drug up to 48 hours post-caesarean section | Intention-to-treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Requiring Emergency Surgery for PPH | At caesarean section up to 48 hours post-caesarean section | Intention-to-treat analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Days of Participants' Hospital Stay | From date of randomization until the day 2 post-caesarean section (date of discharge from hospital) or date of death whichever comes earlier | Intention-to-treat population | days | MEDIAN |
| SECONDARY | Neonatal Outcome - Weight | From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier | Intention-to-treat population | grams | MEAN |
| SECONDARY | Neonatal Outcome - APGAR Score of the Neonates at 1 Minute and 5 Minutes After Delivery | Scores at 1 minute from time of delivery and at 5 minutes after delivery | Intention-to-treat analysis | units on a scale up to 10 | MEDIAN |
| SECONDARY | Neonatal Outcome - Number of Neonates Admitted to the Neonatal Unit | From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier | Intention-to-treat population | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Postpartum Haemorrhage (PPH) | Group A | PPH based on Haematocrit calculation | 48 | Participants | |
| Number of Participants With Postpartum Haemorrhage (PPH) | Group B | PPH based on Haematocrit calculation | 54 | Participants | |
| Number of Participants With Postpartum Haemorrhage (PPH) | Group A | PPH based on Haemoglobin calculation | 56 | Participants | |
| Number of Participants With Postpartum Haemorrhage (PPH) | Group B | PPH based on Haemoglobin calculation | 71 | Participants | |
| Estimated Blood Loss | Group A | Visually estimated blood loss | 483.73 | Standard Deviation 182.56 | ml |
| Estimated Blood Loss | Group B | Visually estimated blood loss | 479.61 | Standard Deviation 139.49 | ml |
| Estimated Blood Loss | Group A | Haematocrit-based calculation of estimated blood loss | 650.06 | Standard Deviation 631.50 | ml |
| Estimated Blood Loss | Group B | Haematocrit-based calculation of estimated blood loss | 653.05 | Standard Deviation 796.03 | ml |
| Estimated Blood Loss | Group A | Haemoglobin-based calculation of estimated blood loss | 644.30 | Standard Deviation 692.27 | ml |
| Estimated Blood Loss | Group B | Haemoglobin-based calculation of estimated blood loss | 707.68 | Standard Deviation 948.01 | ml |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A | 253 | |
| Overall Study | STARTED | Group B | 253 | |
| Overall Study | COMPLETED | Group A | 224 | |
| Overall Study | COMPLETED | Group B | 227 | |
| Overall Study | NOT COMPLETED | Group A | 29 | |
| Overall Study | NOT COMPLETED | Group B | 26 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypotension | Cardiac disorders | Group A | 3 | 224 | |
| other | Hypotension | Cardiac disorders | Group B | 1 | 227 | |
| other | Headache | Nervous system disorders | Group A | 1 | 224 | |
| other | Headache | Nervous system disorders | Group B | 1 | 227 | |
| other | Nausea | Gastrointestinal disorders | Group A | 2 | 224 | |
| other | Nausea | Gastrointestinal disorders | Group B | 0 | 227 | |
| other | Vomiting | Gastrointestinal disorders | Group A | 1 | 224 | |
| other | Vomiting | Gastrointestinal disorders | Group B | 1 | 227 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A | 0 | 224 |
| Total, all-cause mortality | Group B | 0 | 227 |
| Total, other adverse events | Group A | 7 | 224 |
| Total, other adverse events | Group B | 3 | 227 |
| Total, serious adverse events | Group A | 0 | 224 |
| Total, serious adverse events | Group B | 0 | 227 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group A vs Group B: Neonatal Outcome - Number of Neonates Admitted to the Neonatal Unit | Trial comparisons |
| Group A vs Group B: Neonatal Outcome - Death | Trial comparisons |
| Group A vs Group B: Number of Participants With Use of Additional Uterotonics | Trial comparisons |
| Group A vs Group B: Neonatal Outcome - Number of Neonates Diagnosed With Jaundice | Trial comparisons |
| Group A vs Group B: Number of Participants With Tranexamic Acid Side Effects | Trial comparisons |
| Group A vs Group B: Number of Participants Requiring Emergency Surgery for PPH | Trial comparisons |
| Group A vs Group B: deaths from any cause | Trial comparisons |
| Group A vs Group B: Neonatal Outcome - Thromboembolic Event | Trial comparisons |
| Group A vs Group B: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03463993
GET https://conductscience.org/api/trials/v1/NCT03463993/results?page=2