Tranexamic Acid for the Prevention of Blood Loss in High Risk Delivered Women

Study Overview
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Brief Summary
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Postpartum hemorrhage and its complications are very well known causes for maternal mortality .Uterine atony is the most common cause for postpartum hemorrhage

Detailed Description
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Postpartum hemorrhage and its complications are very well known causes for maternal mortality and morbidity especially in developing countries. World Health Organization Recommendations for Active Management of the Third Stage of Labor (AMTSL), on 2012 included the use of uterotonics for the prevention of postpartum hemorrhage (PPH) during the third stage of labor for all births. Tranexamic acid (TA) is antifibrinolytic agent used to decrease blood loss in surgery and health conditions associated with increased bleeding. A Cochrane Systematic Review from the best available evidence to determine whether TA is effective and safe for preventing PPH in comparison to placebo or no treatment the review concluded that TA (in addition to uterotonic medications) decreases blood loss postpartum and prevents PPH and blood transfusions following vaginal birth and abdominal delivery in women at low risk of PPH based on studies of mixed quality. There was insufficient evidence to draw conclusions about serious side effects and the effects of TA on venous thromboembolic events and mortality beside its use in high-risk women was not investigated on

Official Title
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Tranexamic Acid for the Prevention of Blood Loss After Vaginal Delivery in a High Risk Pregnancy: A Double Blind Randomized Controlled Trial

Conditions
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Postpartum Hemorrhage, High Risk Pregnancy, Tranexamic Acid, Third-Stage Postpartum Hemorrhage, With Delivery

Intervention / Treatment
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* Drug: Tranexamic acid injection
* Other: Glucose water 5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 year. Planed vaginal delivery Grand multiparity Twin pregnancy Polyhydramnios Previous history of PPH Macrosomic baby Prolonged labour HELLP syndrome Using of low-molecular weight heparin and Asprin during pregnancy. Vaginal birth after Cesarean section Exclusion Criteria: Intrauterine death. History of thromboembolic disease Current or previous history of heart disease ,renal and liver disorders History of seizure or epilepsy Placenta previa Placental abruptio

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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No

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
Interventional Model Description: Two infusion bags will be prepared and labeled as bag A (experimental group) containing 1 g/10mL Tranexamic acid diluted with 20mL of 5% glucose water, and bag B (placebo group) containing 30 mL of 5% glucose water. Providers and patients will be blinded to the contents of the bags until the end of the study. TA or placebo will be administered intravenously immediately after the delivery of the fetus.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic group<br>Group A will receive 1gm Tranexamic acide diluted in 20 ML 5% glucose water | Drug: Tranexamic acid injection<br>* Participant in group A will receive 2 ampules of 5 milliliters (mL) Tranexamic acid applied to 20 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus<br>* Other names: TRENAXA 500 mg, MACLEODS PHARMACEUTICALS LTD.India;Other: Glucose water 5%<br>* Group B will receive 30 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus<br>* Other names: Glucose B.Braun 50 mg/mL;|
| Placebo Comparator: Placebo group<br>Group B will receive 30ML 5% glucose water | Drug: Tranexamic acid injection<br>* Participant in group A will receive 2 ampules of 5 milliliters (mL) Tranexamic acid applied to 20 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus<br>* Other names: TRENAXA 500 mg, MACLEODS PHARMACEUTICALS LTD.India;Other: Glucose water 5%<br>* Group B will receive 30 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus<br>* Other names: Glucose B.Braun 50 mg/mL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of vaginal blood loss in the third and fourth stages (the fourth begins with delivery of the placenta and ends 2 hours after delivery) | The volume of blood loss vaginally will be measured by weighing a specially prepared pad applied beneath the delivered women buttocks before the delivery of the fetus. An electronic scale will be used to weigh the pads before and after 2 hours of the delivery. The quantity of blood (ml) will be = (weight of used materials - weight of materials prior to use) | From the time of injection and up to 2 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participant with Post Partum Hemorrhage | Vaginal blood loss of more than 500 mL | up to 2 hours after delivery | 
| Number of participant with severe postpartum hemorrhage | Vaginal blood loss ≥1000mL | up to 2 hours after delivery | 
| Number of participant who will need additional uterotonic drugs to control blood loss | Methyl Ergometrine 0.2 mL, 20 IU oxytocin , and/or 800 misoprostol rectally | up to 2 hours after delivery | 
| the mean length of third stage of labor in both groups | time from injection of the intervention and placebo group till the delivery of placenta | up to 30 minutes |