Tranexamic Acid vs Placebo: Number of Participants With Seizure Activity That Was Not Seen Prior to Study Enrollment
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 | 0.000395 | 0.000108 | 0.00144 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0 | 0 | 0.000768 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.000395 | -0.000425 | 0.00144 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | ClinicalTrials.gov | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | ClinicalTrials.gov | |||
| Number needed to treat, for one more participant with the outcome on Tranexamic Acid than on Placebo | 2,530 | 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) | 2 | 5,069 | 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) | 0 | 4,996 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With Seizure Activity That Was Not Seen Prior to Study Enrollment | ClinicalTrials.gov |
| Description | This is the number of mothers who experienced seizure activity, confirmed by central review, whose onset is after enrollment | ClinicalTrials.gov |
| Time frame | within 6 weeks postpartum | ClinicalTrials.gov |
| Population | Participants who received study medication are included according to the treatment received; only those with follow-up through 6 weeks postpartum are included. Additionally, 5 enrolled for a second pregnancy (4 in the tranexamic acid group and 1 in the placebo group) only included the result from the first enrolled pregnancy (when available) since participants were only permitted to be enrolled in the study one time. | 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.