A Phase 2/3 interventional study of Tranexamic acid tablets and Placebo oral tablet in Placenta Previa, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by Ain Shams University · Phase 2/3, Interventional, and Prevention
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).
93 studies on the registry are indexed under Placenta Previa; 20 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 53 interventional studies indexed under Placenta Previa.
Browse Placenta Previa studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.
Drug: Tranexamic acid tablets
100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.
Drug: Placebo oral tablet
Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.
Also known as: Kapron(R)
Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.
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.
Time frame: 9 weeks GA
Number of women requiring antepartum blood transfusion
Number of women requiring antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.
Time frame: 9 weeks GA
Number of PRBCs units required during antepartum blood transfusion
Number of PRBCs required during antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.
Time frame: 9 weeks GA
Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery
Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery
Time frame: 9 weeks GA
Gestational age at delivery
Gestational age in weeks at the time of delivery
Time frame: 9 weeks GA
Neonatal intensive care unit (NICU) admission
Number of neonates requiring NICU admission.
Time frame: 9 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Ain Shams University