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The aim of the study is to assess the prophylactic role of tranexamic acid in reducing blood loss during and after elective cesarean section delivery in high risk patients.
Comparing effect of administration of 1gm of TXA half an hour before elective C-section , effect of administration of 1gm of TXA on the start of uterine incision and placebo effect, Where in all an addition of prophylactic uterotonics is given, in a randomized control, double blind trial of 3 groups.
All patients will undergo the following
I. History : Medical history, Obstetric history, Comorbidities, Allergies. II. Clinically: Vital signs, Abdomino-pelvic examination, per-vaginal examination.
III. Laboratory: Hemoglobin, Hematocrit before & after cesarean section. IV. Routine Ultrasound. V. Cesarean section: done under spinal anathesia.
VI. Calculation of blood loss:
The quantity of blood loss (ml) is calculated from 3 components :
VII. Informed Consent: will be obtained from all participants including the pregnant women who are included in the study .
All patients will receive routine ecbolics ( oxytocin ) after delivery of baby.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preoperative | Experimental | 1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) 30 mins before the operation |
|
| uterine incision | Experimental | 1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) directly before uterine incision |
|
| placebo | No Intervention | 1ml of normal saline will be given |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) | Drug | IV 1gm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of blood loss during C-section. | ml | 1 hour |
| Prevention of 1ry postpartum hemorrhage. | ml | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of hospital stay. | Number of days | 48 hours |
| Decrease risk of maternal blood transfusion | Number of blood products units | 48 hours |
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Inclusion Criteria:
High risk women undergoing elective C-section
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayman Hany, MD | Associate professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Egypt |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000249 | Adenosine Monophosphate |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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