Tranexamic Acid in Pregnancies With Vaginal Bleeding

Study Overview
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Brief Summary
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Tranexamic acid has been proposed and used for prevention and management of antepartum and postpartum hemorrhage.

Detailed Description
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Bleeding during pregnancy is associated with a three- to fourfold increase in perinatal mortality. Hemorrhage in pregnancy is characterized by activation of the fibrinolytic system. Tranexamic acid is a potent pharmaceutical agent that suppresses fibrinolysis, and thus can be used for managing hemorrhage in pregnancy. The FDA's pregnancy category for tranexamic acid is category B. Tranexamic acid has been used to decrease blood loss and treatment of intra partum blood loss in cesarean section also it has been used for prevention and management of postpartum hemorrhage after vaginal bleeding, regardless of whether the bleeding is due to genital tract trauma or other causes.

Official Title
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Tranexamic Acid for Antepartum Bleeding of Unknown Origin in the Second and Third Trimester: Nonrandomized Controlled Trials

Conditions
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Vaginal Bleeding During Pregnancy

Intervention / Treatment
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* Drug: Tranexamic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant woman having vaginal bleeding Second and third trimester of unknown etiology No placenta previa, abruptio placentae, local cervical or vaginal causes for bleeding Primigraivid, multiparous and grand multiparous woman Accept to participate in the trial Exclusion Criteria: Hypersensitivity to tranexamic acid Women with acquired defective color vision History of venous thromboembolism Refused to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 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: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Tranexamic acid was prescribed for pregnant women with vaginal bleeding of unknown etiology in second and third trimester (13-34 weeks) gestation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional arm<br>Tranexamic acid applied intravenously for 2 days followed by oral tranexamic acid | Drug: Tranexamic Acid<br>* One gram( 2 ampules ) of tranexamic acid was received by the participant intravenously twice daily for 48 hours followed by 500 mg tranexamic acid tablet three times daily for 5 days . follow up of the patient was done by recurrence of the bleeding latter on during pregnancy . the course of treatment was repeated again .<br>* Other names: TRANSAMIN , NIKOLAKOPOULOS A.E. GALATSIOU AVENUE, Athens;|
| Placebo Comparator: comparative group<br>expectant management, including admission to hospital, ultrasound examination at least twice a week, regular blood coagulation tests, fetal wellbeing , frequent ultrasound performing for placenta location ,betamethasone administration for whom delivery was suspected | Drug: Tranexamic Acid<br>* One gram( 2 ampules ) of tranexamic acid was received by the participant intravenously twice daily for 48 hours followed by 500 mg tranexamic acid tablet three times daily for 5 days . follow up of the patient was done by recurrence of the bleeding latter on during pregnancy . the course of treatment was repeated again .<br>* Other names: TRANSAMIN , NIKOLAKOPOULOS A.E. GALATSIOU AVENUE, Athens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cessation of vaginal bleeding as self-reported by women | Following up the pregnant woman clinically to approve cessation of vaginal bleeding after Tranexamic acid use using yes/No format | 7 days | 
| Gestational age | Newborn delivered before, at or after 20 weeks gestation in weeks | up to 7 days postpartum | 
| Rate of perinatal deaths | total number of newborn delivered showing no signs of life (movement, appearance, cardiac pulsation) plus deaths of newborn in first week of life | 7 dya after delivery | 
| Neonatal Apgar(Appearance, Pulse, Grimace, Activity, and Respiration) score Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed <0-3>, moderately depressed<4-6> and excellent condition<7-10> | Apgar scores includes 10 sores , 2 for each . The Apgar score was classified as severely depressed 0-3, moderately depressed 4-6 and excellent condition 7-10 | Up to fifth minutes of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antepartum bleeding, Perinatal morbidity, Perinatal mortality, Preterm labor