Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa

Ain Shams University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Placenta Previa

Treatments: Drug: Tranexamic acid tablets; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04055194

AntenatalTRX-PP

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Tranexamic acid group

Active Comparator group

Description:

100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.

Treatment:

Drug: Tranexamic acid tablets

Placebo group

Placebo Comparator group

Description:

100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.

Treatment:

Drug: Placebo oral tablet