Phase 2
N=100
The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery
Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT01085006 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcome: Primary: The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward — 260; 380 ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tranexamic acid (Drug); Normal saline (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Tehran University of Medical Sciences
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward |
260; 380 | — |
| SECONDARY Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery |
— | — |
Summary
Intravenous Tranexamic acid is used to reduce the hemorrhage during and after cesarean delivery in a double blind randomized placebo controlled trial.
Eligibility Criteria
Inclusion Criteria
- Term pregnancy
- Single fetus
- Maximally only one previous cesarean delivery
Exclusion Criteria
- More than one previous cesarean delivery
- Hx of other abdominal or pelvic surgery
- Hx of medical disorders
- Hx of thromboembolic disorders
- Polyhydramnios
- Macrosomia
- Preeclampsia
- Hx of sensitivity to Tranexamic acid
- Abnormal Pt, PTT, PT or INR
Data sourced from ClinicalTrials.gov (NCT01085006). 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.