Tranexamic Acid in Pregnancies With Vaginal Bleeding
- Conditions
- Vaginal Bleeding During Pregnancy
- Interventions
- Registration Number
- NCT03632824
- Lead Sponsor
- Hawler Medical University
- Brief Summary
Tranexamic acid has been proposed and used for prevention and management of antepartum and postpartum hemorrhage.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 139
- 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
- Hypersensitivity to tranexamic acid
- Women with acquired defective color vision
- History of venous thromboembolism
- Refused to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description interventional arm Tranexamic Acid Tranexamic acid applied intravenously for 2 days followed by oral tranexamic acid comparative group Tranexamic Acid 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
- Primary Outcome Measures
Name Time Method Gestational age up to 7 days postpartum Newborn delivered before, at or after 20 weeks gestation in weeks
Rate of perinatal deaths 7 dya after delivery total number of newborn delivered showing no signs of life (movement, appearance, cardiac pulsation) plus deaths of newborn in first week of life
Cessation of vaginal bleeding as self-reported by women 7 days Following up the pregnant woman clinically to approve cessation of vaginal bleeding after Tranexamic acid use using yes/No format
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> Up to fifth minutes of life 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hawler Medical University
🇮🇶Erbil, Kurdistan Region, Iraq