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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group will be given tranexamic acid | Active Comparator | 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:
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|
| Control group | Placebo Comparator | The control group will not be given Tranexamic acid but only the standard management ( Oxytocin ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid 100 milligram/Milliliter | Drug | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Volume of blood loss | 150 ml/pack | 30 minutes after baby delivery |
| Measure | Description | Time Frame |
|---|---|---|
| transfusion requirements | number of women transfused blood | 7 days postpartum |
| additional medical intervention | number of patients were treated by an additional medical intervention |
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Inclusion Criteria:
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:
women with high risk for postpsrtum hemorrhage after ceserean section
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed A Morad, MD | Contact | 0201224214435 | awalid217@yahoo.com | |
| Abubaker M Elnashar, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Abubaker M Elnashar, MD | Benha Faculty of Medecine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha university hospital | Recruiting | Banhā | Banha | 13511 | Egypt |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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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:
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|
|
| Oxytocin | Drug | both groups will be given oxytocin as a standard management |
|
|
| 48 hours postpartum |
| additional surgical or radiological interventions to control bleeding | number of patients were treated by additional surgical or radiological intervention | 7 days postpartum |
| Change in maternal hematocrit concentration | Hematocrit concentration (Percent) | 48 hours postpartum |
| Tranexamic acid side effects | number of patients suffered from side effects | 24 hours postpartum |
| thromboembolic events | number of patients suffered from thromboembolic events | 7 days postpartum |
| Maternal death | Number of women will die. | 7 days postpartum |
| Benha University | Active, not recruiting | Banhā | Banha | 13511 | Egypt |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |