Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Tranexamic Acid

Criteria

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.