Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa
- Registration Number
- NCT04055194
- Lead Sponsor
- Ain Shams University
- Brief Summary
200 pregnant women with symptomatic placenta previa with previous bleeding attacks attending Ain Shams University maternity hospital will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 200
- Gestational age 28 weeks of gestation.
- Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using transvaginal ultrasound scan.
- Haemodynamically stable pregnant women.
- Maternal age:20-40years old.
- Pregnant women with placenta previa, and had previous bleeding attacks or admitted with antepartum haemorrhage.
- Multiple pregnancy.
- Women with bleeding tendency due to any medical disorder (ITP, thrombocytopenia, coagulopathies),or on anticoagulants .
- Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery.
- Women have hypersensitivity or any contraindication to use of tranexamic acid.
- Pregnant women with placenta previa with doppler showing morbidly adherent placenta.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tranexamic acid group Tranexamic acid tablets 100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery. Placebo group Placebo oral tablet 100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.
- Primary Outcome Measures
Name Time Method Amount of bleeding during antepartum bleeding attacks 9 weeks GA Amount of bleeding during antepartum bleeding attacks will be estimated by hemoglobin change from baseline at admission till delivery.
- Secondary Outcome Measures
Name Time Method Number of PRBCs units required during antepartum blood transfusion 9 weeks GA Number of PRBCs required during antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.
Number of women requiring antepartum blood transfusion 9 weeks GA Number of women requiring antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.
Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery 9 weeks GA Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery
Gestational age at delivery 9 weeks GA Gestational age in weeks at the time of delivery
Neonatal intensive care unit (NICU) admission 9 weeks Number of neonates requiring NICU admission.
Trial Locations
- Locations (1)
Ain SHams Maternity Hospital
🇪🇬Cairo, Abbaseya, Egypt