Tranexamic Acid vs Placebo: Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0364 | 0.0318 | 0.0416 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0426 | 0.0376 | 0.0483 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00622 | -0.0135 | 0.00107 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.854 | 0.71 | 1.03 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.849 | 0.7 | 1.03 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Tranexamic Acid than on Placebo | 161 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Tranexamic Acid | Tranexamic Acid for intravenous administration~Tranexamic Acid: A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward) | 201 | 5,525 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Normal saline for intravenous administration~Placebo: 50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward) | 233 | 5,470 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells | ClinicalTrials.gov |
| Description | Participants were monitored from delivery until hospital discharge or 7 days after delivery (postpartum), whichever is sooner. This is the number of mothers who died for any reason, or had a blood transfusion of 1 or more units (of packed red blood cells, including whole blood or cell saver). | ClinicalTrials.gov |
| Time frame | by hospital discharge or by 7 days postpartum, whichever is sooner | ClinicalTrials.gov |
| Population | Of 5529 participants, 4 were enrolled in the study for a second pregnancy in the tranexamic acid group and out of 5471 participants, 1 was enrolled for a second pregnancy in the placebo group. Since participants were only permitted to be enrolled in the study one time, only the first pregnancy was included in the analysis. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean | ClinicalTrials.gov |
| NCT number | NCT03364491 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Obstetrical Complications, Hemorrhage, Labor and Delivery | ClinicalTrials.gov |
| Interventions | Tranexamic Acid, Placebo | ClinicalTrials.gov |
| Lead sponsor | The George Washington University Biostatistics Center | ClinicalTrials.gov |
| Results first posted | 2023-01-19 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03364491?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.