The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage

Study Overview
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Brief Summary
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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.

Detailed Description
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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 : (weight of used towels during surgery - weight of used towels prior to surgery),plus (volume of blood sucked in suction container after placental delivery) ,plus (weight of used vaginal pad in the first 2 hours after CS - the pad' s dry weight) Each 1 mg increase the weight of either the towels or the vaginal pads is equivalent to 1 ml blood loss (Vitello, Dominic J., et al). 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.

Official Title
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The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage

Conditions
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High Risk Pregnant Women Undergoing Elective Cesarean Section

Intervention / Treatment
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* Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High risk women undergoing elective C-section Hypertensive patients. Obese patients. Patients on LMWH. Transverse lie DM ( Type 1 & Gestational ) Cardiac ( Not on Anticoagulants ) Placenta Previa ( Not in PAS ) Previous uterine scar ( > previous 2 C- section ) Exclusion Criteria: Patients with bleeding tendency. HELLP Syndrome. Emergency C- section. Mechanical prosthetic valve Atrial Fibrillation. Allery to tranexamic acid Placenta Accreta , Increta , percreata.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preoperative<br>1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) 30 mins before the operation | Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)<br>* IV 1gm<br>|
| Experimental: uterine incision<br>1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) directly before uterine incision | Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)<br>* IV 1gm<br>|
| No Intervention: placebo<br>1ml of normal saline will be given | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of blood loss during C-section. | ml | 1 hour | 
| Prevention of 1ry postpartum hemorrhage. | ml | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high risk pregnancy, cesarean section., tranexamic acid