Trial · NCT04733157
The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
NCT04733157, Phase 3, Completed, University of Zimbabwe; results first posted 2023-03-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section. Trials, record NCT04733157. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04733157
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
- NCT number
- NCT04733157
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,226 participants, actual
- Lead sponsor
- University of Zimbabwe
- Conditions
- Postpartum Hemorrhage
- Interventions
- Tranexamic acid injection, Normal saline placebo
- First posted
- 2021-02-01
- Last updated
- 2023-03-20
- Results first posted
- 2023-03-20
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Postpartum Hemorrhage (PPH) | 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. |
| Secondary | Blood Loss Using Hemoglobin Values | Up to day 2 postpartum | Calculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values |
| Secondary | Mean Blood Loss as Estimated by Obstetrician | 2 hours | Visually estimated blood loss at time of caesarean section. Attending obstetrician gave an estimated value of blood loss after delivery. |
| Secondary | Occurrence of Postpartum Shock | Up to day 2 postpartum | Number of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse. |
| Secondary | Use of Supplementary Uterotonic(s) | Up to day 2 postpartum | Number of women requiring supplementary uterotonics |
| Secondary | Postpartum Transfusion | Up to day 2 postpartum | Number of women given postpartum transfusion |
| Secondary | Emergency Surgery for PPH | Up to day 2 postpartum | Number of participants who had emergency surgery for PPH including caesarean hysterectomies |
| Secondary | Change in Peripartum Haemoglobin | 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. |
| Secondary | Number of Participants With a Decrease in Peripartum Hemoglobin | Up to day 2 postpartum | Number of participants with a drop in hemoglobin more than 2g/dL or less than 2g/dL |
| Secondary | Change in Peripartum Haematocrit | Up to day 2 postpartum | Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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 Hemorrhage (PPH) | Up to day 2 postpartum | Postpartum hemorrhage defined as having a blood loss greater than or equal to 1000 mL using change in hemoglobin values. In the clinical trial, some participants in both arms had missing data because they did not have their laboratory measurements for hemoglobin done. In Group A (93 participants) and in Group B (87 participants) had missing assessments for PPH. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Blood Loss Using Hemoglobin Values | Up to day 2 postpartum | Average blood loss in mL calculated using laboratory hemoglobin values collected from participants before and after procedure. | mL | MEAN |
| SECONDARY | Mean Blood Loss as Estimated by Obstetrician | 2 hours | Missing data for some participants due to estimates not being done at the time of delivery. | mL | MEAN |
| SECONDARY | Occurrence of Postpartum Shock | Up to day 2 postpartum | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Use of Supplementary Uterotonic(s) | Up to day 2 postpartum | Missing information about additional uterotonics for some participants due to data entry issues after delivery. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Postpartum Transfusion | Up to day 2 postpartum | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Emergency Surgery for PPH | Up to day 2 postpartum | Missing information from some participants due to data entry issues. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Peripartum Haemoglobin | Up to day 2 postpartum | Missing values due to missing information if blood draws were not done within the required time frame. | g/dL | MEAN |
| SECONDARY | Number of Participants With a Decrease in Peripartum Hemoglobin | Up to day 2 postpartum | Missing data a result of laboratory specimens not being collected at the expected time from participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Peripartum Haematocrit | Up to day 2 postpartum | Missing data due laboratory measurements not being done for some participants as samples were not taken within required time frame. | percent of hematocrit change | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group92
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 Hemorrhage (PPH) | Study Group/Group A_(Tranexamic Acid) | Did not have PPH (blood loss <1000 mL) | 409 | Participants | |
| Number of Participants With Postpartum Hemorrhage (PPH) | Control Group/Group B_(Placebo) | Did not have PPH (blood loss <1000 mL) | 399 | Participants | |
| Number of Participants With Postpartum Hemorrhage (PPH) | Study Group/Group A_(Tranexamic Acid) | Had PPH (blood loss >=1000 mL) | 111 | Participants | |
| Number of Participants With Postpartum Hemorrhage (PPH) | Control Group/Group B_(Placebo) | Had PPH (blood loss >=1000 mL) | 125 | Participants | |
| Blood Loss Using Hemoglobin Values | Study Group/Group A_(Tranexamic Acid) | 537.2 | Standard Deviation 758.2 | mL | |
| Blood Loss Using Hemoglobin Values | Control Group/Group B_(Placebo) | 528.6 | Standard Deviation 1020.9 | mL | |
| Mean Blood Loss as Estimated by Obstetrician | Study Group/Group A_(Tranexamic Acid) | 501.2 | Standard Deviation 209.8 | mL | |
| Mean Blood Loss as Estimated by Obstetrician | Control Group/Group B_(Placebo) | 495.0 | Standard Deviation 188.8 | mL | |
| Occurrence of Postpartum Shock | Study Group/Group A_(Tranexamic Acid) | No postpartum shock | 603 | Participants | |
| Occurrence of Postpartum Shock | Control Group/Group B_(Placebo) | No postpartum shock | 611 | Participants |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Study Group/Group A_(Tranexamic Acid) | 613 | |
| Overall Study | STARTED | Control Group/Group B_(Placebo) | 613 | |
| Overall Study | COMPLETED | Study Group/Group A_(Tranexamic Acid) | 611 | |
| Overall Study | COMPLETED | Control Group/Group B_(Placebo) | 613 | |
| Overall Study | NOT COMPLETED | Study Group/Group A_(Tranexamic Acid) | 2 | |
| Overall Study | NOT COMPLETED | Control Group/Group B_(Placebo) | 0 |
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 | Nausea | Gastrointestinal disorders | Study Group/Group A_(Tranexamic Acid) | 9 | 611 | 9 |
| other | Nausea | Gastrointestinal disorders | Control Group/Group B_(Placebo) | 16 | 613 | 16 |
| other | Vomiting | Gastrointestinal disorders | Study Group/Group A_(Tranexamic Acid) | 29 | 611 | 29 |
| other | Vomiting | Gastrointestinal disorders | Control Group/Group B_(Placebo) | 18 | 613 | 18 |
| other | Dizziness | General disorders | Study Group/Group A_(Tranexamic Acid) | 12 | 611 | 12 |
| other | Dizziness | General disorders | Control Group/Group B_(Placebo) | 14 | 613 | 14 |
| serious | Myocardial Infarction | Cardiac disorders | Study Group/Group A_(Tranexamic Acid) | 0 | 611 | 0 |
| serious | Myocardial Infarction | Cardiac disorders | Control Group/Group B_(Placebo) | 1 | 613 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Study Group/Group A_(Tranexamic Acid) | 0 | 611 |
| Total, all-cause mortality | Control Group/Group B_(Placebo) | 0 | 613 |
| Total, other adverse events | Study Group/Group A_(Tranexamic Acid) | 50 | 611 |
| Total, other adverse events | Control Group/Group B_(Placebo) | 48 | 613 |
| Total, serious adverse events | Study Group/Group A_(Tranexamic Acid) | 0 | 611 |
| Total, serious adverse events | Control Group/Group B_(Placebo) | 1 | 613 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37106343 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| D43TW009343 | University of California Launching Future Leaders in Global Health Research Training Program | COHEN, CRAIG R; LEE, SUNG-JAE; MARTIN, NATASHA; MARTINEZ LOPEZ, BEATRIZ | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | FOGARTY INTERNATIONAL CENTER | 2017 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Study Group/Group A_(Tranexamic Acid) vs Control Group/Group B_(Placebo): deaths from any cause | Trial comparisons |
| Study Group/Group A_(Tranexamic Acid) vs Control Group/Group B_(Placebo): 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/NCT04733157
GET https://conductscience.org/api/trials/v1/NCT04733157/results?page=2