Placenta Previa Clinical Trial
Official title:
Efficacy of Antenatal Tranexamic Acid in Pregnant Women With Symptomatic Placenta Previa in Decreasing Antepartum Hemorrhage - A Randomized Controlled Trial
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).
Status | Recruiting |
Enrollment | 200 |
Est. completion date | August 1, 2020 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain SHams Maternity Hospital | Cairo | Abbaseya |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Amount of bleeding during antepartum bleeding attacks | Amount of bleeding during antepartum bleeding attacks will be estimated by hemoglobin change from baseline at admission till delivery. | 9 weeks GA | |
Secondary | Number of women requiring antepartum blood transfusion | Number of women requiring antepartum blood transfusion for resuscitation after severe antepartum hemorrhage. | 9 weeks GA | |
Secondary | Number of PRBCs units required during antepartum blood transfusion | Number of PRBCs required during antepartum blood transfusion for resuscitation after severe antepartum hemorrhage. | 9 weeks GA | |
Secondary | Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery | Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery | 9 weeks GA | |
Secondary | Gestational age at delivery | Gestational age in weeks at the time of delivery | 9 weeks GA | |
Secondary | Neonatal intensive care unit (NICU) admission | Number of neonates requiring NICU admission. | 9 weeks |
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