A Phase 1/2 interventional study of Tranexamic Acid 100 milligram/Milliliter and Oxytocin in Postpartum Hemorrhage, sponsored by Benha University. Status unknown at 2 sites in Egypt. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-13.
Sponsored by Benha University · Phase 1/2, Interventional, and Prevention
Use of tranexamic acid (TXA) for the prevention of postpartum haemorrhage (PPH) after cesarean section in high-risk patients ( a randomized control trial ).
Participants will be divided into two groups: a study group \& a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute).
The second dose of TXA 1 g Intravenous can be given if:
445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
This study's planned enrollment of 60 is below the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Scheduled or unscheduled cesarean delivery. Singleton or twin gestation.
Women at high risk for PPH after cesarean section:
Placenta previa, accreta, increta or percreta. haematocrit (HCT) \< 30%. Bleeding at admission. History of Postpartum haemorrhage. Abnormal vital signs (hypotension or tachycardia). Previous Cesarean or uterine surgery. More than four previous deliveries. Multiple Gestation. Large Uterine fibroids. Chorioamnionitis. Magnesium sulphate use. Prolonged use of oxytocin.
Exclusion Criteria:
Participants will be divided into two groups: a study group \& a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute). The second dose of TXA 1 g Intravenous can be given if: * Bleeding continues after 30 minutes * Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess the efficacy of TXA in the prevention of PPH and reduction of intraoperative and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).
Drug: Tranexamic Acid 100 milligram/Milliliter · Drug: Oxytocin
The control group will not be given Tranexamic acid but only the standard management ( Oxytocin )
Drug: Oxytocin
Participants will be divided into two groups: a study group \& a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute). The second dose of TXA 1 g Intravenous can be given if: * Bleeding continues after 30 minutes * Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess the efficacy of TXA in the prevention of PPH and reduction of intraoperative and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).
Also known as: Study group
both groups will be given oxytocin as a standard management
Also known as: Control group
Volume of blood loss
150 ml/pack
Time frame: 30 minutes after baby delivery
transfusion requirements
number of women transfused blood
Time frame: 7 days postpartum
additional medical intervention
number of patients were treated by an additional medical intervention
Time frame: 48 hours postpartum
additional surgical or radiological interventions to control bleeding
number of patients were treated by additional surgical or radiological intervention
Time frame: 7 days postpartum
Change in maternal hematocrit concentration
Hematocrit concentration (Percent)
Time frame: 48 hours postpartum
Tranexamic acid side effects
number of patients suffered from side effects
Time frame: 24 hours postpartum
thromboembolic events
number of patients suffered from thromboembolic events
Time frame: 7 days postpartum
Maternal death
Number of women will die.
Time frame: 7 days postpartum
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Benha University